Natural Cycles NCTG3 Manual de usuario
Instructions
For Use
NC° THERMOMETER (GEN3)
Model number NCTG3
This thermometer is being imported under FDA
Enforcement Policy for Clinical Electronic Thermometers
During the Coronavirus Disease 2019 Public Health
Emergency. This device meets performance requirements
but is not yet FDA-cleared.
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Contents
Introduction 4
Warnings And Cautions 6
Operating Your Thermometer 9
Maintenance 14
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Introduction
Please read and save these instructions
Thank you for purchasing the NC° Thermometer (Gen3),
Please read these instructions carefully to ensure proper
use and safe operation of your thermometer. If you have
any questions or comments about the thermometer,
contact Customer Support at help@naturalcycles.com.
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Thermometer key parts
Front
Tip Wand History button Display
Battery hatchNFC zone symbol
Plastic tab
Power button
Back
Settings button
Tip is the part of the thermometer
that is applied to the mouth.
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Package Contents
• NC° Thermometer (Gen3)
• Instructions for Use
• Founder welcome card
The Thermometer is intended to be used on its own or with
iOS/Android smartphones using a dedicated App.
Indications for Use
The NC° Thermometer (Gen3) is used orally for the
intermittent measurement and monitoring of human body
temperature. The device can be used by adults and children
over the age of 5 years old.
Warnings And Cautions
The thermometer may be used by itself or alongside the
Natural Cycles app. See Natural Cycles application IFU for
information regarding use of the app.
• This product is not intended to diagnose or treat any
health problem or disease and should not be used as a
substitute for the consultation and advice of a physician
or other medical professional.
• The thermometer should not be used by children under the
age of 5. The thermometer should only be used by children
over the age of 5 if under the supervision of an adult.
• This thermometer should be held during use; the user
should be seated or lying down during measurements.
• Keep the device away from sources of high levels of power
line magnetic elds to reduce the likelihood of interference.
° The device is suitable for use in all environments
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listed in these instructions for use, including
domestic environments.
° The use of the device may be limited in the
presence of electromagnetic disturbances. This
could result in issues such as error messages
or the failure of the display/device.
• If the thermometer is not likely to be used for some time,
please remove the battery.
• Don’t use near active HF surgical equipment and the RF
shielded room of an ME system for magnetic resonance
imaging, where the intensity of EM disturbances is high.
• 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.
• Use of accessories, transducers, and cables other than
those specied 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 12 in (30 cm)
to any part of the equipment, including cables specied
by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
Precautions
• This thermometer uses Bluetooth Low Energy 5.0 and
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Near Field Communication (NFC) to interact with a
dedicated iOS/Android smartphone App.
• Clean the thermometer probe before and after use.
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 the Care and Cleaning section.
• Keep out of reach of young children and pets. Do not
bend or bite the probe as this may damage the probe.
• Do not use the thermometer if there are signs of
damage or after a drop/shock that might have caused
damage. If damaged, do not attempt to repair. Please
contact Customer Support at help.naturalcycles.com.
• Parts of the NC° Thermometer (Gen3) are not to be
serviced or maintained while in use with the patient.
• The patient is the intended operator.
• The NC° Thermometer (Gen3) is a continuous
operating device per IEC 60601-1.
• Do not store in direct sunlight or at high temperatures
–see Product Specications section.
• Avoid exercise and drinking hot or cold beverages
before taking a temperature as these activities
may affect the accuracy of the measurement. If the
thermometer has been stored in cold conditions, it
should be left for 30 minutes to stabilize to room
temperature before attempting a measurement.
• The use of heat and cold producing devices, such
as electric heating blankets, heating pads or ice
packs, may impair the performance of the device and
increase the risk of injury to the patient.
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• The manufacturer recommends using a password on
your smartphone.
About Temperature Measurements
Normal oral temperature measurements vary throughout
the day. Level of activity, time of day, beverages, smoking
and other factors may also affect body temperature.
This device is calibrated at the time of manufacturing. No
recalibration is required. Contact Customer Support at
help.naturalcycles.com for any accuracy issues.
Operating Your Thermometer
The Thermometer can either be used by itself or the user
can sync the temperature data to the Natural Cycles app
on their smartphone. Before using the thermometer for the
rst time, pull the plastic tab sticking out of the battery
hatch to activate the battery.
To Set Up Your Thermometer With A New Mobile Device
1. Open iOS/Android Natural Cycles smartphone app for
additional pairing instructions if using thermometer
with smartphone. When the thermometer nds the
smartphone app, a connection is established.
2. Press the settings button on the thermometer. Pressing
the settings button will make the thermometer look for
the app to establish connection for 60 seconds, if the
app is not found, the thermometer shuts itself off.
3. Once the thermometer connects with the phone/device,
you should see the setup complete screen.
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Fahrenheit Celsius Switchable Feature
The thermometer takes measurements in both Fahrenheit
and Celsius. When the thermometer is off, press and hold
the settings button for 5 or more seconds to switch the
measurements from Fahrenheit to Celsius or Celsius to
Fahrenheit. The thermometer screen will conrm the switch
to Fahrenheit or Celsius. You can change thermometer
settings in the app as well.
History Mode
The thermometer includes a recall of the past ten
temperatures taken. Press the history button to see the last
temperature. Continue pressing the history button to see
previous temperatures one at a time up to ten temperatures.
Oral Use
1. Press the power button and then place the thermometer
in your mouth to begin measuring.
2. Place the probe under the tongue as near as possible to
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