Natural Cycles NC° Thermometer Gen 2 Bluetooth Thermometer Instruction Manual

Natural Cycles NC° Thermometer Gen 2 Bluetooth Thermometer

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.

INTENDED USE
The NC° Thermometer (Gen 2) is a medical digital thermometer (direct mode) for the self-measurement of human basal body temperature. The device transmits the measured values to the Natural Cycles app via a Blue-tooth 4.0 interface. The device is intended for use with the Natural Cycles app. The device cannot be operated with other apps.

SAFETY INSTRUCTIONS

• The device must be used solely for the purpose described in these operat-ing instructions. The manufacturer shall not be held liable for any damages resulting from improper use.
• Do not allow the thermometer to fall on the floor. The thermometer is not shock-resistant or impact-resistant.
• Protect the device from dirt, dust and strong sunlight and keep the device away from excessive heat or cold.
• Using the thermometer in a way that does not comply with the intended operating conditions can result in inaccurate measurement values. Before each measurement, check the integrity of the measuring tip. A dam-aged measuring tip can cause injuries.
• Do not bite or bend the sensor. This can cause damage and lead to mal-functions.
• The use of this device near mobile phones, radios or other strong electro-magnetic fields can cause errors and malfunctions. Maintain a distance of at least 3.3 metres from such devices when using the device. If you cannot maintain the minimal distance check that the thermometer is working cor-rectly before using it.
• The thermometer contains small parts that could be swallowed by children. Do not leave the device unattended with children.
• Do not open the device (except when changing the battery).
• If the device is not being used for an extended period of time, remove the battery.
• Always store the thermometer in the protective cover.
• If the device has been stored at temperatures below 10°C or above 40°C, allow it to stand at room temperature for at least 2 hours before using it.

DEVICE DESCRIPTION

1. Gold-plated measuring tip
2. Bluetooth button
3. Illuminated display
4. On/off button
5. Battery compartment

DISPLAY

1. Temperature unit
2. Bluetooth data connection
3. Battery display
4. Date
5. Memory mode
6. Synchronising
7. Time

INITIAL DEVICE SETUP

You must install the Natural Cycles app on your smartphone before setting up the device for the first time. The NC° Thermometer (Gen 2) cannot be set up without the Natural Cycles app.
Download the Natural Cycles app from the App Store or Google Play.

Open the Natural Cycles app. Follow the instructions in the app.
Now initiate the initial setup of the thermometer. To do this, hold the Bluetooth button for at least 1 second. The device switches on and automatically goes into SET mode, where you can set the date and time (Fig-ure 1).
The date and time are synchronised automatically from the Natural Cycles app. To do this, the device con-nects to the app via Bluetooth (Figure 2).
If the connection is successful, the “APP” indicator ap-pears (Figure 3).
If the device cannot connect to the app, it switches off after 60 seconds. If this occurs, check whether Blue-tooth is enabled on your smartphone and that the Natural Cycles app is running. Now try to establish a connection again.

TEMPERATURE MEASURING
Remove the transparent protective cover from the thermometer before taking a measurement.
Switch on the device by pressing and holding the on/off button for at least 1 second. The word “On” will ap-pear on the display (Figure 1).
The device now performs an internal self-test; all dis-play elements are displayed (Figure 2).

Checking the transfer status

The device now checks whether all previous measurement values have already been transferred to the Natural Cycles app. The device can temporarily store up to 30 measurements.

The number of measurement values not yet transferred is shown on the display (Figure 3).
If more than 25 saved measurements have not been transferred to the Natural Cycles app, the message “APP/FULL” (Figures 4 and 5) appears on the display to remind you to transfer the measurement values to the app as soon as possible.

If you perform more than 30 measurements without transferring the values to the app, the oldest value is deleted to make room for a new measurement.

Once the transfer status has been checked, the display flashes and/or a beep is sounded. The device is now ready to perform a new measurement.
Never begin a measurement before the display flashes and/or the beep sounds (if the sound is activated). The thermometer must already be in measurement mode when you start measuring to be able to correctly record the progress of the measurement.

Measuring temperature

Place the probe tip underneath your tongue on either the left-hand or right- hand side. The temperature sensor must make good contact with the tissue.
Close your mouth and breathe calmly through your nose so that the meas-urement result is not affected by the air that you breathe.
As long as the measured temperature remains below the measuring range (32.00°C to 43.99°C), the display shows L (low) (Figure 6). Have a little patience during the measurement. The sensor must first warm up from room temperature to body temperature.

During the measurement, the current temperature is shown on the display. You must wait until the measurement is complete to ensure the accuracy of the temperature value.

A long beep indicates that the measurement is com-plete. If the sound is deactivated, the display flashes to indicate that the measurement is complete. The measurement value is shown on the display (Figure 7). If the thermometer measures an elevated tempera-ture of 37.50 °C or above, the display will illuminate yellow and/or 10 beeps will sound in rapid succes-sion. The display switches between showing the tem-perature and “HI” (fever alert, Figure 8).
The device now tries to establish a Bluetooth con-nection to transfer the measured value to the Natural Cycles app. Make sure that the smartphone is within range, Bluetooth is enabled and the Natural Cycles app is running.

If the connection is successful, the “APP” indicator ap-pears (Figure 9). Once the data has been transferred, the thermometer switches off automatically (Figure 10). If the device cannot establish a connection, the meas-urement value is stored on the device to be transferred later. The device can temporarily store up to 30 meas-urement values. The thermometer then switches itself off (Figure 10).

MANUALLY TRANSFERRING DATA TO THE NATURAL CYCLES APP
If the measurements cannot be transferred to the Natural Cycles app im- mediately after the measurement (e.g. if your smartphone is not within Bluetooth range or the Natural Cycles app is not open), you can transfer the measurements to the Natural Cycles app at a later date. To do so, proceed as follows:

Open the Natural Cycles app on your smartphone.
With the device switched off, press and hold the Bluetooth button for at least 1 second, but no more than 5 seconds, until the Bluetooth symbol appears in the display. If you hold down the button for more than 5 seconds, you will enter memory recall mode.
The device now connects to the app via Bluetooth (Figure 1).

If the connection is successful, the “APP” indicator appears (Figure 2).
If the device cannot connect to the Natural Cycles app, it switches itself off after 60  seconds. If this occurs, check whether Bluetooth is enabled on your smart- Figure 2 phone and that the Natural Cycles app is running, then try again.

RECALLING SAVED MEASUREMENT VALUES
The thermometer has a measurement value memory with 30 save slots. The measurement values are saved automatically together with the date and time of the measurement. The most recently measured value is stored in save slot 1; the value measured prior to that is stored in save slot 2, and so on. If more than 30 measurements are taken, the oldest value (no. 30) is deleted so that the most recent value (no. 1) can be saved.

The measurement values and lots of additional information are saved in the Natural Cycles app, where they can be analysed with ease.
You can also recall the last 30 readings directly from the NC° Thermometer (Gen2). To do so, proceed as Figure 1 follows:
With the device switched off, press and hold the Bluetooth button for at least 5 seconds until the icon appears on the display. The device switches to memory mode (Figure 1).

The most recently measured value, no. 1, is now dis- Figure 2 played (Figure 2, Figure 3). The display switches between the measurement value and the year, month/day and time. For measurement values that have been transferred to the Natural Cycles app, the symbol is displayed. Figure 3
By repeatedly pressing the Bluetooth button, you can call up the previous measurements (no. 2, no. 3 …).
If no measurement values are saved, the following appears on the display (Figure 4):

BATTERY DISPLAY/CHANGING THE BATTERY
The device is equipped with a CR2032 lithium battery.
If the battery icon flashes on the display while the thermometer is in use, the battery is low (Figure 1). You can still perform some temperature measurements at this point, but you should have a spare battery ready.

Change the battery if:
After switching on the device, the “battery flat” indicator (Figure 2) appears on the display. You must insert a new battery before you can take any temperature measurements.
Nothing is shown on the display despite pressing the on/off button.

Unlock the battery cover by turning it past the marker to the left. Then lift the cover off.
Remove the old battery and insert a new battery (CR2032) with the “+” symbol facing up.

Place the cover back on the battery compartment and lock it in place. After changing the battery, the thermometer must be connected to the Natural Cycles app so that the date and time can be resynchronised. To do this, open the Natural Cycles app and turn on the thermometer. Until you have done this, you cannot take any new temperature measurements. Measurement values stored on the device are retained when the battery is changed.

CHANGING DEVICES

Each NC° Thermometer (Gen 2) has a unique signature assigned to a spe-cific user. Signatures are assigned during initial setup when the device is synchronised with the Natural Cycles app for the first time.
If your device is lost or faulty, you can assign a new NC° Thermometer (Gen 2) to your user account.

To do this, go to the Top Menu in the Natural Cycles app and follow the instructions.
Please note: If you change device during a cycle, the current cycle becomes inactive in the Natural Cycles app. For your safety, the app only accepts measurement data from a single device during a cycle.

ERROR MESSAGES

TECHNICAL DATA

± 0.10°C in other temperature ranges

Memory:| 30 measurement values with date and time can be recalled in memory mode
Operating conditions:| Ambient temperature 10°C to 40°C, maximum relative humidity 15% to 95%
Conditions for storage and transport:| -25°C to +55°C, maximum relative humidity 15% to 95%
Time to adjust from minimum/ maximum storage temperature to operating temperature:| 30 minutes
Battery:| 1 x CR2032, 3.0 V, mercury-free
Battery life:| approx. 400 measurements
Data transfer:| Bluetooth 4.0 LE (low energy)
IP classification:| IP67: dust tight, protection against

temporary submersion

---|---
Expected service life:| 5 years
Dimensions:| 137 mm (L) x 32 mm (W) x 15 mm (H)
Weight:| 27 g with battery

CUSTOMER SERVICE

Device repairs may only be performed by the manufacturer or an expressly authorised body. Please contact:
NaturalCycles Nordic AB
St Eriksgatan 63b
112 34 Stockholm, Sweden
help.naturalcycles.com
www.naturalcycles.com

We recommend a technical inspection of the device every 5 years. This in- spection can be carried out either by UEBE Medical GmbH or by authorised maintenance services.

EXPLANATION OF SYMBOLS

This product complies with Council Directive 93/42/EEC of 5 Sep-tember 2007 concerning medical devices and bears the mark CE 0123 (TÜV SÜD Product Service GmbH).

DISPOSAL
Technical equipment and batteries do not belong in household waste. They must be disposed of at appropriate collection and disposal points.

CLEANING AND CARE

• Clean the thermometer with a soft cloth and isopropyl alcohol diluted with water or cold, soapy water.
• Do not use aggressive cleaning agents, solvents or petroleum spirit to clean the device.
• The thermometer can be immersed in water or a disinfectant solution when cleaning. Do not sterilise the device by boiling it, using gas or placing it in a steam autoclave.
• Make sure that the surface of the measuring sensor and the display do not get scratched.
• After cleaning the measuring sensor with alcohol, wait 5 minutes before taking the next temperature measurement so that the thermometer can return to the required operating temperature.

WARRANTY

The device has been manufactured and tested with all due care. Neverthe-less, in the event of defects upon delivery, we provide a warranty under the following conditions:
During the warranty period of 2 years from the date of purchase, we remedy such defects at our discretion and at our expense in our plant through repair work or replacement delivery of a defect-free device.
The warranty does not cover normal wear and tear of wearing parts or damage caused by failure to observe the instructions for use, improper handling (e.g. unsuitable power sources, breakage, leaking batteries) and/or disassembly of the device by the buyer.

Furthermore, the warranty does not constitute grounds for asserting claims for damages against us. Warranty claims can only be asserted during the warranty period and upon presentation of the proof of purchase. In the case of a warranty claim, the device along with the proof of purchase and a description of the complaint must be sent to:

NaturalCycles Nordic AB
St Eriksgatan 63b
112 34 Stockholm
Sweden

The cost of returning the device to our factory shall be borne by the sender. Complaints that are sent back without prepayment will not be accepted. The statutory claims and rights of the buyer against the seller (for example, defect claims, producer liability) are not restricted by this warranty. Please note: In the case of a warranty claim, please make sure to enclose the proof of purchase.

NaturalCycles Nordic AB
St Eriksgatan 63b
112 34 Stockholm
Sweden
help.naturalcycles.com
www.naturalcycles.com

References

• Natural Cycles: Natural Birth Control | No Hormones or Side Effects

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