TytoCare TytoHome User manual

www.tytocare.com
TytoHome™
Important Safety Information

IMPORTANT SAFETY INFORMATION
Please read, view, understand and follow all safety
information contained in this document and the user
manual prior to using the TytoHome™ unit. For complete
instructions, please refer to the User Guide, which is
available through the TytoApp either through the About
screen before login, or through the Menu icon at the top-left
corner after login.
You should retain these printed instructions for future
reference.
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.
EN
701-00030 A02

Intended use for Tyto
Otoscope
The Tyto Otoscope is an electronic
otoscope that enables capturing
and transmission of video and still
images of the external ear canal
and tympanic membrane,
whereby a clinician at one
location on an IP network can
view images and videos of a
patient on site or at a different
location on the IP network with the
signal carried on an IP connection
between the two locations.
Intended use for Tyto
Stethoscope
The Tyto Stethoscope is an
electronic stethoscope that
enables transmission of
auscultation sound data, whereby
a clinician at one location on an
IP network can listen to the
auscultation sounds of a patient
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 Stethoscope is intended to be
used by professional users in a
clinical environment or by lay
users in a nonclinical
environment. The Device is for
medical diagnostics purposes
only. The Device is not intended
for self-diagnosis.
Intended use for Tyto
Exam Camera
The Tyto Camera is an electronic
camera that enables capturing
and transmission of video and still
images of throat (with/without
tongue depressor) and skin,
whereby a clinician at one
location on an IP network can
view images and videos of a
patient on site or at a different
location on the IP network with the
signal carried on an IP connection
between the two locations.
Intended use for Tyto
Thermometer
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.

Contraindications: None known.
Unpacking - View the Instruction
Video on unpacking available on
the TytoApp.
Make sure that all parts of the
TytoHome™ Device were properly
shipped.
General Safety Messages
Warning:
If the Device packaging, the
Device itself or any of its
accessories are damaged or not
intact, do not use the Device.
Do not immerse the Device or any
of its accessories in water or any
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.
The system contains no user-
serviceable components. Do not
disassemble, service or repair this
product or any of its parts.
Disposal of this Device should be
performed in accordance with
local regulations.
If Device is not working as
expected, discontinue use. Refer
servicing to qualified service
personnel.
Use the equipment only for the
purpose described, as explained
in this user guide.
Do not use accessories which are
not supplied or recommended by
the manufacturer.
Do not remove the covers of the
Device components.
Do not use Device during
defibrillator use.
Do not use the Device on an open
wound or on infected skin.
Use of this equipment adjacent to
or stacked with other equipment
should be avoided because it
could result in improper
operation. If such use is
necessary, this equipment and the
other equipment should be
observed to verify that they are
operating normally.
Other equipment could interfere
with the Tyto Device, even if the
other equipment complies with
CISPR emission requirements.
If the Tyto Device does not
respond due to EM phenomena,
you can force a shutdown. Press
and hold the physical button on
the top of the Device for ten
seconds to force the system to
shut down and restart.
Use of accessories, transducers
and cables other than those
specified or provided by the
manufacturer of this equipment
could result in increased
electromagnetic emissions or
decreased electromagnetic
immunity of this equipment and
result in improper operation.
Portable RF communications
equipment (including peripherals
such as antenna cables and
external antennas) should be
used no closer than 30 cm (12
inches) to any part of the Tyto
Device, including cables specified
by the manufacturer. Otherwise,

degradation of the performance
of this equipment could result.
Caution:
Connect only authorized
accessories to the Device.
If the LCD screen is broken or
cracked, or the image quality is
poor, please contact TytoCare
Support.
If the LCD screen is dirty, clean
the screen with a dry cloth or
towel.
If the Device does not turn on or
initialize properly, the splash
screen does not appear, or if it
cannot be turned off, contact
TytoCare Support.
If the audible speaker does not
sound briefly or the LED does not
turn on during system
initialization, contact TytoCare
Support.
If the LED does not turn on during
Throat, Skin or Ears
exam, contact TytoCare Support.
If you see static artifacts on videos
or images, or if the image quality
is insufficient, contact TytoCare
Support.
The Restore to Factory Defaults
option in the menu will erase all
Device settings and data, and will
restore the Device to its initial as-
new state.
Examinations cannot be
performed while the Device is
charging.
Use only the charging cable
provided with the Device. If the
Device doesn’t charge, contact
TytoCare Support.
To charge the Device, plug the
charging cable into the USB port
on your computer or a UL-
certified USB wall charger
supporting at least 2.0A.
Use only a secured Wi-Fi network
such as WPA2 wireless encryption.
If data or instructions are not
displayed on the mobile device
during an examination, view the
Tyto Device screen.
Note:
If for any reason you cannot
perform the connection between
the Device and the TytoApp,
contact TytoCare Support.
When 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.
The Device connection screen in
the TytoApp should only be used
to connect to another Device or to
disconnect from an existing
Device.
Operating conditions: 5° to 40°
Celsius (41° to 104° Fahrenheit) /
15% to 70% humidity (non-
condensing).
For Tyto Thermometer:
16° to 40° Celsius (60.8° to 104°
Fahrenheit).

Storage conditions: -20° to 60°
Celsius / -4° to 140° Fahrenheit /
15% to 70% humidity (non-
condensing).
When charging, the activity LED
will be purple, and when charging
is complete, it will turn blue.
The Device complies with wireless
standard IEEE 802.11 g/n (2.4GHz,
5GHz).
A medical diagnosis should only
be provided by a physician.
Contact with solvents can cause
severe deterioration of the plastic
parts and malfunctioning of the
instrument and accessories.
If the Device image quality is
poor, please contact TytoCare
Support.
The Tyto Device consists of
high-quality precision parts. Do
not drop the instrument. Protect it
from severe impact and shock.
Never insert a sharp object into
the scanner area or any other
open surface of the Device.
Store the Device charged, and
re-charge it once every 3 months.
Storing the Device when the
battery is drained may shorten the
battery life.
The Device has been dyesigned
for practical use, but is not a
substitute for a visit to the
doctor/clinician.
Tyto Otoscope
Note:
Do not use disposables that have
cracks or contain sharp edges.
Discard the disposable ear
speculum after use.
Warning:
When starting an ear exam, it is
important to select the correct ear
(left or right), and to correctly
identify the side that you are
recording. Mixing between sides
could mislead the diagnosing
clinician.
Be careful NOT TO TOUCH THE
EARDRUM. If the canal is blocked
or obstructed by
wax / cerumen, stop the
examination and pull back the
Tyto Otoscope.
Stop once you get a view of the
eardrum. Do not push the Tyto
Otoscope any further! You can
use the yellow dotted circle as a
guide to know when you are too
close to the eardrum. During an
online visit, update the clinician
when you see the eardrum.
Do NOT let the tip of the Tyto
Otoscope get too close to the
eardrum. It must NOT touch the
eardrum.
When performing an online exam
while the clinician experiences
poor network conditions, the
TytoApp might stop displaying the
video. In case of self-examination,
it is important to tap ACTIVATE

VIDEO to resume the Otoscope
video playback.
Tyto Stethoscope
Warning:
Wheezing and respiratory issues
can progress quickly and be fatal.
The Tyto Stethoscope is not
intended for self-diagnosis, and
results should be referred to a
professional. The local emergency
number should be called in the
event of any respiratory event that
causes concern.
The Device has been designed for
practical use, but is not a
substitute for a visit to the doctor.
Note:
Who can use the Tyto
Stethoscope:
lAdults aged 18-65.
lPersons comfortable using
mobile apps.
lPersons able to manage their
own healthcare.
If you wear eyeglasses, contacts
or hearing aids, please use them
while using the Tyto Stethoscope.
Interpreting stethoscope
recordings / auscultations
requires professional training and
self-diagnoses is not
recommended.
Sending recordings: Stethoscope
recordings of the heart and lung
may contain information that can
be used to diagnose and monitor
severity of diseases, like asthma or
bronchiolitis.
Please check TytoApp instructions
for how to send recordings to your
physician or another party.
Tyto Exam Camera
When performing a throat exam,
if the tongue depressor
disconnects from the tongue
depressor holder, for example as
a result of the patient biting the
tongue depressor, gently pull the
tongue depressor out of mouth, or
wait until the patient releases the
tongue depressor.
Tyto Thermometer
Caution:
For 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.
Use in a draft-free space and out
of direct sun or near radiant heat
sources. Do not use in close
proximity to air conditioning or
heating vents.
Please follow the general safety
precautions when using on
children.
Remove any sweat prior to
measuring with a dry cloth.

Avoid any cooling or warming
cloths on the forehead for at least
30 minutes prior to measurement.
Before taking a measurement,
remove dirt or hair from the
forehead area. Wait 10 minutes
after cleaning the forehead area
before taking measurement.
Keep the measurement sensor
clean. Avoid directly touching the
sensor.
Note:
The Tyto Thermometer is a non-
contact forehead thermometer.
The reading displayed is
equivalent to oral thermometer
temperature.
When prompted, aim the
thermometer at an inner wall, at
about the height of the patient
and tap Start Calibration to start
the calibration process and
measure the room temperature.
The Tyto Thermometer has been
clinically tested and proven to be
safe and accurate when used in
accordance with the user guide.
Please note that using the
thermometer not in accordance
with the operation, storage and
cleaning instructions may lead to
inaccurate temperature
measurement.
The temperature 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 temperature
exceeds 37.4°C [99.32°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, cancer
chemotherapy, chronic steroid
treatment, splenectomy).
lPatients who are bedridden
(such as nursing home patients,
stroke, chronic illness,
recovering from surgery).
lA transplant patient (such as
liver, heart, lung, kidney).
Do not allow children to take their
temperatures unattended.
Even in the absence of fever,
please consult your clinician 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,
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.
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.
A child’s normal temperature can
be as high as 37.7°C (99.86°F) or
as low as 36.1°C (96.98°F).
This thermometer reads 0.5°C
(0.9°F) lower than a rectal digital
measurement.
Always hold the thermometer and
the forehead steady when taking
a reading. Do not move the
thermometer until you hear the
final beep. Do not take a
measurement while or
immediately after nursing a baby.
Patients should not drink, eat, or
be physically active before/while
taking the measurement. Remove
hats and wait 10 minutes before
taking a temperature
measurement.
Always take the temperature
exactly as directed. Temperature
results may vary if positioned in
the wrong location.
In the following situations, it is
recommended that three
temperature readings be taken in
the same location 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 familiarized
themselves with the instrument
and obtains consistent
readings.
Cleaning and Disinfection
Instructions Before Use
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 to
air dry for at least two minutes
before taking a measurement.
Make sure the tongue depressor
holder, blade 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, blade
and otoscope tip and allow it to
air dry for at least two minutes.
Don’t reuse the tongue depressor
if you notice signs of material
degradation such as scratches.
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.
Note:
As the Tyto Stethoscope is placed
directly on the skin, please use
wipes or cloth moistened with 70%
isopropyl alcohol or pads
impregnated with 70% ethyl
alcohol to disinfect the Tyto
Stethoscope membrane (black
surface touching the skin) before
each use.
Thoroughly wipe the Tyto
Stethoscope membrane and allow
it to air dry for at least two
minutes.
Use a 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.
After Use
Storage instructions
If you are not using the Device for
an extended period, charge the
Device at least every 3 months.
Store the Device and the
components in a clean and safe
location.
Do not store the Device in a wet,
humid or dusty location.
Do not store the Device outside
the above-mentioned storage
conditions.
Do not store the Device where it is
directly exposed to sunlight.
User responsibility
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 of the
TytoHome Device by anyone other
than TytoCare or persons or
entities designated by TytoCare.
The safety, reliability, and
performance of the TytoHome™
Device can only be assured under
the following conditions:
lTytoHome™ has been used
according to its intended use
and according to this guide
and guides accesible through
the TytoApp.
lAll fittings, extensions,
readjustments, changes, or
repairs have been carried out
by a TytoCare authorized
representative.
Electrical safety and
electromagneticcompatibility
The Device complies with the
requirements of IEC/EN 60601-1
for 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.