TytoCare TytoPro User manual

TytoPro
Tyto Thermometer
User Guide
August 2019
Document Number: 760-00263 A01

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TytoPro Tyto 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.
© 2019 TytoCare Ltd. All rights reserved.
Manufacturer Information
TytoCare Ltd.
14 Beni Gaon Street,
Netanya, Israel 4250803
Tel: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.tytocare.com

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TytoPro Tyto 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 8
Operation Environment 9
Manual Calibration 9
Guided Exam 10
Select the TEMP Exam 10
Video Tutorial and Animation 10
Before You Start How to Conduct the Exam 11
Position the Device 11
Perform the Exam 12
Temperature Display 12
Unguided Exam 14
Select the TEMP Exam 14
Take Temperature Reading from the Forehead 14

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TytoPro Tyto 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 Thermometer is a non-contact clinical infrared thermometer intended for intermittent
determination of human body temperature from the center of the forehead on people of all ages.
The Tyto Thermometer is intended for use by both adult lay users and clinicians. It can be used
both at home and in clinic environments.
In Canada: Not recommended for children aged 2 years and under
Product Overview
The Tyto Thermometer™ is a user-friendly, non-contact, electronic, infrared thermometer that
measures body temperature.
The Tyto Thermometer connects to the Tyto App on your mobile device (iPhone, iPad or iPad Mini)
to facilitate the process of storing the recorded data and communicating data with clinicians.
Recorded results may be forwarded for review by a clinician in a different location.

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TytoPro Tyto Thermometer User Guide
General Safety Messages/Product Overview
The Tyto Thermometer is designed for a clinical or home environment, for use in several
scenarios:
lBy an individual clinician/healthcare professional
lBy a clinician/healthcare professional, who forwards exam data to another clinician/healthcare
professional for later diagnosis
lBy a clinician/healthcare professional, who collaborates online with another clinician during or
after the examinations.
lBy an adult lay user at home
This infrared thermometer meets requirements established in ASTM Standard (E1965-98) and ISO
80601-2-56 standards. Full responsibility for the conformance of this product to the standard is
assumed by TytoCare Ltd.
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 36°C - 39°C (96.8°F - 102.2°F)
range
0.3°C (0.5°F) accuracy outside the above range.
Complies with ASTM E1965-98 & ISO 80601-2-56
Resolution 0.1°F (0.1°C)

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TytoPro Tyto Thermometer User Guide
Before the Exam
Before the Exam
Warning:
lUse the equipment only for the purpose described, as explained in this user manual.
lUse of this thermometer is not intended as a substitute for consultation with your physician.
lOnly perform maintenance procedures specifically described in this user manual.

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TytoPro Tyto Thermometer User Guide
Before the Exam
Note: The Tyto 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.
.........................................................................................................................................................
The measurement must be taken on dry skin. Perspiration on the skin can adversely affect the
results.
.........................................................................................................................................................
Temperature elevation may signal a serious illness, especially in neonates and infants, or in
adults who are old, frail, or have a weakened immune system. Please seek professional advice
immediately when there is a temperature elevation and if you are taking temperature on:
lNeonates and infants under 3 months (Consult your physician immediately if the tem-
perature exceeds 37.4°C [99.4°F]).
lPatients over 60 years of age (Fever may be blunted or absent in older patients).
lPatients having diabetes mellitus or a weakened immune system (such as HIV positive, can-
cer chemotherapy, chronic steroid treatment, splenectomy).
lPatients who are bedridden (such as nursing home patient, stroke, chronic illness, recov-
ering from surgery).
lA transplant patient (such as liver, heart, lung, kidney).
.........................................................................................................................................................
Do not allow children to take their temperatures unattended.
.........................................................................................................................................................
Please consult your doctor if you see symptoms such as unexplained irritability, vomiting,
diarrhea, dehydration, changes in appetite or activity, seizure, muscle pain, shivering, stiff
neck, pain when urinating, etc., even in the absence of fever.
.........................................................................................................................................................
Even in the absence of fever, those who exhibit a normal temperature may still need to
receive medical attention. People who are on antibiotics, analgesics, or antipyretics should not
be assessed solely on temperature readings to determine the severity of their illness.

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TytoPro Tyto Thermometer User Guide
Before the Exam
Caution:
lFor the most accurate results, the Tyto Thermometer and patient should remain in the same
environment and at room temperature for 30 minutes before performing the measurement.
lDo not use the device on an open wound or on infected skin.
lDo not take temperature measurements over scar tissue, open sores or abrasions.
lPlease follow the general safety precautions when using on children.
lRemove any sweat prior to measuring with a dry cloth.
lAvoid any cooling or warming cloths on the forehead for at least 30 minutes prior to meas-
urement.
lBefore taking a measurement, remove dirt or hair from the forehead area. Wait 10 minutes
after cleaning the forehead area before taking measurement.
lThis thermometer consists of high-quality precision parts. Do not drop the instrument. Pro-
tect it from severe impact and shock.
lNever insert a sharp object into the scanner area or any other open surface of the ther-
mometer.
lKeep the measurement sensor clean. Avoid directly touching the sensor.
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.

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TytoPro Tyto Thermometer User Guide
Before the Exam
Operation Environment
Tyto Thermometer should be operated only in room temperatures of 60.8 - 104°F / 16 - 40°C, and
humidity of 15 - 70% (non-condensing)
Manual Calibration
When prompted, you’ll need to aim the
thermometer towards an inner wall, at
about the height of the patient and press
“Start Calibration” to start the calibration
process, and measure the room
temperature.
Bear in mind, the Tyto Thermometer
measures the room temperature to
accurately measure your body
temperature, therefore you are required to
be in the same room for 30 minutes before
the exam. The Thermometer features a
self-calibration mechanism, activated automatically when turned on - so usually manual
calibration will not be needed.

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TytoPro Tyto Thermometer User Guide
Guided Exam
Guided Exam
Note: Refer to the TytoProTM General Operation User Guide (Document number: 760-
00263) 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 Thermometer User Guide
Guided Exam
Before You Start How to Conduct the Exam
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 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 device close to the skin, not
exceeding 2 inches (5 cm) from forehead.
For most accurate results, avoid touch with
the skin.
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 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 Thermometer and the Tyto App show the measured temperature value:
Tap Repeat 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 body temperature, and was adjusted to be the
same as when taken orally.

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TytoPro Tyto 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.
Note: It is important to know each individual’s normal temperature when they are well.
This is the only way to accurately diagnose a fever. Take multiple readings when healthy to
determine normal temperature.
Note: A child’s normal temperature can be as high as 37.7°C (99.9°F) or as low as 36.1°C
(97.0°F). Be sure to note this unit reads 0.5°C (0.9°F) lower than a rectal digital measurement.
Note: Always hold the thermometer and the forehead steady when taking a reading. Do not
move the thermometer until you hear the final beep. Don’t take a measurement while or
immediately after nursing a baby.
Note: Patients should not drink, eat, or be physically active before/while taking the
measurement. Remove hats and wait 10 minutes before taking a measurement.
Note: Always take the temperature exactly as directed. Temperature results may vary if
positioned in the wrong location.
Note: In the following situations it is recommended that three temperatures in the same
location be taken and the highest one taken as the reading:
lChildren under three years of age with a compromised immune system and for whom the
presence or absence of fever is critical.
lWhen users are learning how to use the thermometer for the first time, until they famil-
iarized themselves with the instrument and obtain consistent readings.

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TytoPro Tyto 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 Thermometer User Guide
Unguided Exam
1. Immediately upon tapping TEMP, place the
Thermometer on the patient’s forehead.
2. Aim The Tyto 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
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 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.