Natural Cycles NCTG3 Degree Thermometer Instructions

Natural Cycles NCTG3 Degree Thermometer

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

Thermometer key parts

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 fields to reduce the likelihood of interference.
  • The device is suitable for use in all environments 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 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 12 in (30 cm) to any part of the equipment, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Precautions

• This thermometer uses Bluetooth Low Energy 5.0 and 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 Specifications 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.

• 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 first 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 finds 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.

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 confirm 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 a heat pocket at the back of the mouth, as noted in the diagram below.
3. Hold the thermometer in place during the measurement; do not bite down on the thermometer. The mouth must remain closed to ensure accurate results. The measurement should take approximately 40 seconds.
4. When the measurement is complete the thermometer will provide feedback. The feedback can be light and/or sound based on user settings. The final temperature value will be displayed on the thermometer screen.
5. After a measurement is completed, simply press the power button to turn the thermometer off or the thermometer will shut off automatically.

Troubleshooting / Error Codes

Performance may be affected should one or more of the following occur:

• Operation outside stated temperature and humidity range
• Storage outside stated temperature and humidity range
• Mechanical shock
• User temperature is below ambient temperature

Syncing temperatures with NC App
You can sync the temperature to your phone right after you measure or later by following the instructions in the app. There are two ways to sync temperatures with the NC app.
After a successful measurement is completed, the thermometer will advertise the value via NFC or Bluetooth. NFC/Bluetooth depends on user settings which can be changed in the NC app.

temperature
try again| below 60.8°F (16°C) or final| again. Make sure that
 | temperature value is too| your environment is in the
 | low, below 89.6°F (32.0°C)| operating range and that the
 |  | thermometer is placed as
 |  | described in the diagram in the
 |  | ‘Oral Use’ section.
Temperature too high,| Starting temperature value is| Try measuring the temperature
try again| above 104°F (40°C) or final| again. Make sure that
 | temperature value is too| your environment is in the
 | high, above 107.6°F (42.0°C)| operating range and that the
 |  | thermometer is placed as
 |  | described in the diagram in the
 |  | ‘Oral Use’ section.
No measurement detected| No placement of| Try measuring the temperature
 | thermometer in mouth| again. Make sure that the
 | detected| thermometer is placed as
 |  | described in the diagram in the
 |  | ‘Oral Use’ section.
Error| Problem/Cause| Solution
---|---|---
Battery low| Battery is depleted| Change the battery as described in the section ‘Replacing The Battery’.

When the thermometer is in History mode it also advertises unsynced values via NFC or Bluetooth.

Syncing temperatures troubleshooting
If you have issues syncing your temperature from the thermometer into the app, please visit help.naturalcycles.com or scan the QR code below and find the instructions for different types of devices.

Maintaining Your Thermometer

Care And Cleaning Instructions
Store the thermometer in the provided protective case when not in use. Do not store the thermometer where it will be exposed to direct sunlight, dust or humidity. Avoid extreme temperatures. Do not attempt to disassemble the thermometer. Clean the thermometer by wiping with 75% medical alcohol solution or mild soap and water. Do not submerge in any liquid or autoclave. Wipe the thermometer with a dry cloth and allow it to air dry.

Replacing The Battery
If the thermometer is low in battery, ‘battery low’ or ‘critically low battery life’ messages will appear on the thermometer screen. Open the hatch in the back of the thermometer to remove the existing battery, and replace it with a new battery.

Product specifications

• Battery                                            CR2032
• Battery voltage                           3V
• Battery Life                                   6 months
• Automatic Shut-Off                       1 minute
• Measurement Range                32-42°C (89.6–107.6°F)
• Suggested Time Between Measurements      10 minutes if device left at rest, 3 minutes if shaking the device in the air
• Measurement Time                    40 seconds nominally
• Accuracy                                       ± 0.1°C / 0.2°F within measurement range
• Operating Temperature               15-40°C (59–104°F)
• Storage Temperature                -25-50°C (-13–122°F)
• Humidity                                        £ 95% R.H.
• Atmospheric Pressure                70 kPa to 106 kPa
• Display                                          OLED Screen
• Display Resolution                      0.01ºC or 0.02°F
• Dimensions                                    136.8mm x 11.0mm x 29.0mm
• Weight                                            25g
• Memory Function                       10 logs
• Service Life                                  5 Years
• RF interface                                  Bluetooth LE(2400–2483.5 MHz): 2402–2480 MHz; 0 dBm NFC (13.56MHz): 13.553˜13.567MHz
• Operating Mode                         Adjusted
• Intended Operator                      Thermometer can be used by adults and children (patient) in non-medical settings.

The operator can contact Customer Support at help@naturalcycles. com to obtain special test mode(DIRECT MODE) data.

FCC Statement

IMPORTANT INFORMATION REQUIRED BY THE FCC
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: this device may not cause harmful interference, and this device must accept any interference received, including interference that may cause undesired operation.

The equipment is suitable for use in domestic establishments and is tested to CISPR emissions Class B Group 1 as well as 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. NC° Thermometer (Gen3) utilizes Bluetooth Low Energy (BLE), which uses the 2.4 GHz ISM band. BLE operates between 2.402 and 2.480 GHz. And Near Field Communication (NFC), Which use the 13.56MHz ISM band. NFC operates between 13.553 and 13.567MHz. NC° Thermometer (Gen3) transmits less than-2 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.

FCC WARNING: Changes or modifications not expressly approved by Intretech could void the user’s authority to operate the equipment.
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 and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation.

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;

• Reorient or relocate the receiving antenna
• Increase the separation between the equipment and receiver
• Connect the equipment to an outlet on a circuit different from that to which the receiver is connected
• Consult the dealer or an experienced radio/TV technician for help

FCC Radiation Exposure Statement
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. Statement
NC° Thermometer (Gen3) conforms to all the requirements established in ASTM standard E1112.

Warranty Information

• The manufacturer provides the warranty of 1 year, starting from the date on which the appliance is sold to the end user
• The warranty only covers defects in material or workmanship
• The repairs under warranty may only be carried out by an authorized service centre. When making a claim under the warranty, the original bill of purchase (with purchase date) must be submitted.

The warranty will not apply in cases of:

• Normal wear and tear
• Incorrect use, e.g. overloading of the appliance, use of non-approved accessories
• Use of force, damage caused by external influences
• Damage caused by non-observance of the user manual, e.g. connection to an unsuitable mains supply or non-compliance with the installation instructions
• Partially or completely dismantled appliances

Proposition 65 Warning
WARNING: This product may contain chemicals known to the State of California to cause birth defects or other reproductive harm.

For more information on Proposition 65 chemicals, please visit: https://www.p65warnings.ca.gov/

Guidance and Manufacturers Declaration

–electromagnetic immunity

|
---|---
Immunity Test| IEC 60601-1-2 Test level| Compliance level
Electrostatic discharge (ESD)| ±8 kV contact| ±8 kV contact
IEC 61000-4-2| ±2 kV, ±4kV, ±8kV, ±15kV air| ±2 kV, ±4kV,

±8kV, ±15kV air

Electrical fast transient/burst IEC 61000-4-4| Not applicable| Not applicable
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11| Not applicable| Not applicable
Power frequency magnetic field IEC 61000-4-8| 30 A/m

50Hz/60Hz

| 30 A/m

50Hz/60Hz

Conducted RF IEC 61000-4-6| Not applicable| Not applicable
Radiated RF IEC 61000-4-3| 10 V/m,

80 MHz – 2,7 GHz,

80 % AM at 1 kHz80 MHz – 2,7

| 10 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

Explanation of Symbols

• Name of the Manufacturer
  Xiamen Intretech Inc.

• Address of the Manufacturer
  No. 100, Dongfu West Road, Haicang District, Xiamen, Fujian, China

• Contact Information
  http://www.intretech.com/
  86-(0)592-5797666

• Device Name
  NC° Thermometer (Gen 3)

• Date of publication
  February 2023

• Document version
  INTRE-9-THERO-IFU-001 v1.2

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