Kinsa Smart Ear Thermometer A-10240 User manual

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Kinsa Smart Ear ThermometerTM
Instructions For Use
Thank you for purchasing the Kinsa Smart Ear
Thermometer™, a professionally accurate instrument for
fast and easy temperature taking in the ear. Please read
these instructions carefully to ensure accurate
temperatures and safe operation.
Your Kinsa Smart Ear Thermometer is optimized for use
with the free Kinsa app, but can be used alone as well. For
the full experience including features such as symptom
tracking and fever guidance, download the app on the
App Store or Google Play store and connect your
thermometer to your mobile device. For the full list of
supported devices, see kinsahealth.com/phones.
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Feel Better.

Product Description
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Power/Start button
Probe
Probe tip
Display
Battery door
Protective cap
Kinsa mobile app
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B
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Intended Use
The Kinsa Smart Ear Thermometer is intended to measure the human body temperature in the ear. This
device is reusable for clinical or home use on both adults and children older than 1 year old.
Warnings And Precautions
This thermometer uses Bluetooth Low Energy 4.1 to communicate with Apple and Android mobile
devices. Please see kinsahealth.com/phones for the full list of supported devices.
Clean the probe before and after use.
Never use the thermometer for purposes other than body temperature measurement. Please follow the
safety precautions when using on children.
The operating ambient temperature range for this thermometer is 60.8 - 104 °F (16 - 40 °C).
Do not expose the thermometer to temperature extremes:
(below -13 °F / -25 °C or over 131 °F / 55 °C) or excessive humidity (>95% RH).
Use of this thermometer is not intended as a substitute for consultation with your physician.
High, prolonged fever requires medical attention. Be sure to contact your physician.
The thermometer is water resistant, not waterproof. Never dip the thermometer into water or other
liquids. Do not boil the probe. For cleaning and disinfecting, please see Cleaning and Storage.
Keep out of reach of unattended children. Do not allow children to walk or run while taking a temperature.
Do not store the unit in direct sunlight or at high temperatures.
Kinsa recommends using a password on your smartphone to protect your information
WARNING Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to SmartEar. Otherwise, degradation
of the performance of this equipment could result.
WARNING: 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.
Power line magnetic fields (in excess of 3A/m) should be kept at a distance to reduce the likelihood of
interference. Warning keep DEVICE away from sources of high levels of power line magnetic fields (in
excess of 30 A/m) to reduce the likelihood of interference
Do not mix alkaline, standard or rechargeable batteries.
Changes or modifications not expressly approved by the party responsible for compliance could void the
user's authority to operate this device.
Features of your Kinsa Smart Ear Thermometer
Fast 1.5 second reading. Meets ASTM standards for professional accuracy.
Gentle and easy to use in the ear, no probe covers needed.
Conveniently displays in °F or °C. Water resistant, for safe cleaning.
Use with or without your mobile device. Connects via Bluetooth Low Energy. Additional Smart
functionality available through Kinsa app.
Body Temperature
Temperature readings vary from person to person, by age, time of day, and by site of measurement. For
example, core body temperature often decreases with age. The best method to determine your own
normal temperature is to use the thermometer when you are feeling well. Record your temperature twice a
day (early morning and late afternoon) using the Kinsa app. Take the average of the two temperatures. This
is considered your normal body temperature. Any variation from it may indicate some sort of illness and
you should consult your physician.
Why Measure in the Ear?
Ear temperatures accurately reflect core body temperature, since the eardrum shares a blood supply with
the temperature control center in the brain: the hypothalamus.1The Kinsa Smart Ear Thermometer
monitors the infrared heat radiated from the eardrum and surrounding tissue and detects once an
accurate temperature measurement has been taken.
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1 Netter H F, Atlas of Human Anatomy, Novartis Medical Education, East Hanover, NJ, 1997, pp 63, 95.
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To Set Up Your Thermometer For First Time Use
Open the battery door .
Insert two AAA batteries (included), making sure the poles are in the right
direction, into the thermometer. Snap battery door into place.
Enable Bluetooth on your mobile device.
Download the Kinsa app from the App Store or Google Play. The app can also
be downloaded by going directly to kinsahealth.com/download. Please see
kinsahealth.com/phones for the full list of supported devices.
Launch the Kinsa app. (The app will be on your Home screen or in your Apps
folder depending on type of mobile device.)
Turn the thermometer on and follow the prompts to install.
Your thermometer is now successfully connected to your mobile device.
For future temperature readings, open the Kinsa app to automatically sync
readings to your mobile device and assign to individual family members, add
notes or symptoms/medications, and see guidance.
Having trouble?
Your thermometer will display APP until it is connected with the Kinsa app.
If your thermometer won't connect to the app, you can activate it on its own
by turning it on and pressing the big white button 2 times in rapid succession.
Note: viewing temperature history or receiving guidance will not be possible
until the thermometer has been connected to the app. For additional
support, contact Customer Happiness at kinsahealth.com/contactus
To Set Up Your Thermometer with Additional Mobile Devices
If you have the original phone, open Kinsa, go to “More,” select the
thermometer to remove and choose “Forget Thermometer.”
On the additional mobile device, repeat Steps 3 through 7 above.
Your thermometer is now successfully connected to an additional
mobile device.
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Taking a Temperature
Tap the Power/Start button Ato turn on the thermometer. You will hear a
beep when the thermometer is ready to take a temperature.
During an internal self-check, the display shows all segments.
The thermometer will be ready for temperature taking when
the screen shows three dashes.
First, gently tug the ear straight up and back. Next, fit the probe snuggly
into the ear canal. Be sure to position the probe so that it is pointing
toward the center of the head. Once in position, push and release the
Power/Start button.
A beep will indicate when the temperature measurement is successfully
completed. Temperature readings typically take 1 second.
The temperature reading will be shown on the illuminated display. A smiling
face icon indicates that the temperature is normal while a neutral or
frowning face indicates a mild or high fever, respectively.
The thermometer will automatically turn off after 30 seconds of inactivity.
The display will briefly flash OFF and it will go blank. You can also hold down
the button to power off.
NOTE: Always take measurements in the same ear since temperature readings may
differ from the right and left ear.
Kinsa recommends taking your temperature three times in the same ear and using the
highest of those readings. This is especially important if you meet the following criteria:
Children under three with a compromised immune system
Individuals unfamiliar with this thermometer
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Understanding Your Thermometer Display
DISPLAY
Battery icon,
empty, blinking
Battery levels:
UPD
APP
ERR
Happy Face
Neutral Face
Sad Face
SITUATION
Battery is critically low
and may not operate
correctly
Changing The Temperature Scale
If you wish to change the temperature scale of your thermometer, turn your
thermometer on and then press the big white button two more times in rapid
succession.
NOTE: temperature scale in app can be changed within app settings.
Replacing the Battery
The Kinsa Smart Ear thermometer is powered by 2 AAA batteries. The low battery
icon displays when power is low. To protect the environment dispose of empty
batteries at appropriate collection sites according to national or local regulations.
Keep out of reach of young children, elderly, and pets. To replace the batteries:
1. Open the back battery cover by pressing on the Kinsa logo and applying
downward pressure to slide it off.
2. Remove the old batteries and replace with new ones. Make sure the the batteries
are in the correct polarity direction.
3. Close the battery cover.
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Firmware update in progress.
Connect to Kinsa app.
Problem detected, check the app for details.
SOLUTION
Insert new batteries.
2 bars = 20–40% battery
1 bar = 5–20% battery
0 bars = less than 5% battery
≥ 96.9°F (36.1°C) and < 100°F (37.8°C)
≥ 100°F (37.8°C) and < 102.6°F (39.2°C)
≥ 102.6°F (39.2°C)

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93.2 °F – 108 °F
60.8 °F – 104 °F
0.1 °F or °C
MAXIMUM LABORATORY ERROR
±0.4 °F
±0.6 °F
–4 °F to 122 °F (–20 °C to 70 °C)
at water vapor pressure up to 50 hPa
0 – 95 % RH (non-condensing)
Two AAA batteries
Approx 2 years
Bluetooth Low Energy v4.1
5000 uses or approx. 3 years
5 years
Displayed temperature range:
Operating ambient temperature range:
Display resolution:
ACCURACY FOR PATIENT TEMPERATURE RANGE
95.0 °F – 107.6 °F (36 °C – 39 °C):
Outside this range:
LONG TERM STORAGE RANGES
Temperature:
Humidity:
OTHER
Battery type:
Battery life:
Bluetooth:
Operation Time/Number of procedures:
Service Life:
(34 °C – 42.2 °C)
(16 °C – 40 °C)
(±0.2 °C)
(±0.3 °C)
Cleaning And Storage
To ensure your Smart Ear thermometer is recording accurate
temperatures, it is very important to keep the probe sensor tip clean.
To clean the probe tip, gently wipe it with a cotton swab or soft cloth
moistened with alcohol. Gently circle the alcohol wipe around the
inner sensor area at the tip of the Smart Ear. Be sure to clean the inner
flat surface of the sensor - not just the rim. Never submerge your
Kinsa or put it in boiling water or a dishwasher.
Keep the protective cap snapped onto the top of the thermometer when not in use to
protect the tip from damage.
Calibration
This thermometer is initially calibrated at the time of manufacture. If this thermometer
is used according to the use instructions, periodic re-adjustment is not required. If at
any time you question the accuracy of temperature measurements, please contact
Customer Support.
Product Specifications
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© Copyright 2017 Kinsa, Inc.
For patents: kinsahealth.com/patents
This thermometer conforms to the following standards:
ASTM Standard E 1965-98:2009 Standard Specification for Infrared Thermometers for Intermittent
Determination of Patient Temperature
IEC/EN 60601-1-2: 2014 «Medical electrical equipment» – Part 1-2: General requirements for safety - electromagnetic
disturbances and electromagnetic emissions
IEC 60601-1-11: 2010 «Medical electrical equipment» - Part 1-11: General requirements for basic safety and
essential performance - Requirements for medical electrical equipment and medical electrical systems used in
the home healthcare environment
FCC Note: This device complies with part 15 of the FCC Rules. Operationis subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause undesired operation. This equipment has been
tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency energy, which could theoretically
cause harmful interference to radio communications. If this equipment does cause harmful interference to
radio or television reception, which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following measures: increase the separation
between the equipment and receiver, consult the dealer or an experienced radio/TV technician for help, or
contact Kinsa customer support.
The equipment is suitable for use in domestic establishments and is tested to CISPR emissions Class B Group 1
as well a home healthcare immunity criteria found in IEC 60601-1-2 Table 4, 6, and Table 9. During the IEC
60601-1-2 immunity tests performed the thermometer will accurately measure temperature or display an error.
Smart Ear utilizes Bluetooth Low Energy (BLE), which uses the 2.4 GHz ISM band. BLE operates between 2.402
and 2.480 GHz. Smart Ear transmits less than 0 dBm effective radiated power. To protect the environment,
dispose of empty batteries at appropriate collection sites according to national or local regulations. Keep out of
reach of young children, elderly and pets.
Manufactured By:
Kinsa, Inc
535 Mission Street, 18th Fl
San Francisco, CA 94105
www.kinsahealth.com
Customer Support: [email protected]
Limited Warranty:
Kinsa, Inc warrants this product against any defects that are due to faulty material or
workmanship for a period of one year from the original date of consumer purchase or receipt as a gift. This
warranty applies when used for normal household use in accordance with the Instructions for Use and excludes
the battery and damage to the product resulting from accident or misuse. This product is not warrantied when
used in a professional environment.
In no event shall Kinsa, Inc be liable for any special, incidental, indirect, or consequential damages in connection
with the purchase or use of this product or costs over the original cost of the product.
If the product should not perform to specifications within the warranty period, please contact Customer
Support.
Explanation of Symbols
0120
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L-10280 Rev A1
A-10240
Consult instructions for use
Temperature limitation
Humidity limitation
Manufacturer batch code
Catalogue number
Non-sterile
Type BF applied part
Do not use if product is
broken, damaged, or open
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FCC ID: 2AFEOE2