TytoCare TytoHome User manual

Document Number 760-00050 Rev 04
Tyto Basal Thermometer
TytoHomeTM
For Basal Body Temperature Measurement
User Guide
Version 3.0

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Tyto Basal Thermometer User Guide
Table of Contents
1. General Safety Messages/Product Overview..................................................................................................................... 3
1.1. General Safety Messages.......................................................................................................................................3
1.2. Product Overview...................................................................................................................................................3
1.3. Technical Specifications:...................................................................................................................................4
2. Before the exam................................................................................................................................................................. 4
2.1. Operation Environment .........................................................................................................................................4
2.2. What is Basal Body Temperature...........................................................................................................................4
2.3. Manual Calibration.................................................................................................................................................5
3. Performing the Exam ......................................................................................................................................................... 5
3.1. Select the TEMP Exam............................................................................................................................................5
3.2. Video Tutorial and Animation................................................................................................................................5
3.3. Before You Start: How to Conduct the Exam.........................................................................................................5
3.4. Position the Device ................................................................................................................................................5
3.5. Perform the Exam ..................................................................................................................................................6
Press START when you are ready to begin the exam....................................................................................................6
3.6. Temperature Display..............................................................................................................................................6
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 Basal Thermometer 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.
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 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.
1.2.
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.
The Tyto Basal Thermometer is designed for a clinical or home environment, for use in several 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.
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.

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Tyto Basal Thermometer User Guide
1.3. 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
0.2°C (0.4°F) accuracy for 38°C - 41°C (100.4°F - 105.8°F) 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)
2.
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 with the operation instruction manual. Please note that using the
thermometer not in accordance with the operation, storage and cleaning instructions may lead to
inaccurate temperature measurement.
For cleaning instructions, refer to the General Operation User Guide. The measurement must be taken on
dry skin. Perspiration on the skin can adversely affect the results.
2.1.
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 the most accurate results, the Tyto device and patient should remain in the same environment and at
room temperature for 30 minutes before performing the measurement.
2.2.
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 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 indicates 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 can be
observed.
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 ovulation.
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

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Tyto Basal Thermometer User Guide
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.
2.3.
Manual Calibration
The Tyto Basal Thermometer also measures the room temperature to accurately measure your basal body
temperature. The 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.
3.
Performing the Exam
Note: Refer to the TytoHomeTM General Operation User Guide for preliminary instructions on
logging in to the system and viewing the Exam menu.
3.1.
Select the TEMP Exam
Choose the TEMP (temperature) exam from the Device screen:
3.2.
Video Tutorial and Animation
The first time you do the exam, a video tutorial will display. It is always available by pressing the question
mark symbol 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.
3.3.
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:
3.4.
Position the Device
When you are ready to begin taking the temperature, aim Tyto device at the center of the forehead, just
between and above the eyebrows, at a distance of no more than 2 inches (5 cm).
Place device close to the skin, not
exceeding 2 inches (5 cm) from forehead

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Tyto Basal Thermometer User Guide
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.
3.5.
Perform the Exam
Press START when you are ready to begin the exam.
Device screen showing correct location
on forehead and Start button
3.6.
Temperature Display
The device and App show the measured temperature value:
Measured temperature
Press Repeat (here in picture Add) to measure the temperature
again, or DONE when you have finished measuring the
temperature. Please refer to the General Operation User Guide,
beginning in Section 7.7.2 Recorded Exams,for further
instructions.
Note: The temperature displayed reflects the basal body
temperature, and is 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 Temperature
units. To apply the change, you’ll need to log out and log in
again.
Hold Tyto steady on the forehead during one timing circle (6 seconds),
until you hear a beep.