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Instructions For Use Model No.: MT16W2 Region: US-FDA Tag: IB-EN Draft Version: 2024-02-12
Instructions for Use:
Device Model #: MT16W2
Product REF #: NCTG2
Introduction
Document Scope
Thank you for purchasing the NC° Thermometer (Gen2)! This instruction of Use contains important information about the
device safety, performance, and operation. If you have any questions or comments about the thermometer, contact
Customer Support at help@naturalcycles.com
Please read these Instructions for Use, the device label, and all other information provided with this product, before using
the device.
Disclaimers
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks
on this device is under license.
Apple, the Apple logo, iPad, and iPhone are trademarks of Apple Inc., registered in the U.S. and other countries. App
Store is a service mark of Apple Inc.
Android and Google Play are both trademarks of Google Inc.
Other trademarks and trade names are those of their respective owners.
Important Information
Device Description
The NC° Thermometer (Gen2) is used orally for the intermittent measurement and monitoring of human body
temperature.
1
Microlife Corporation
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Summary of Contents for Microlife MT16W2
- Page 1 Instructions For Use Model No.: MT16W2 Region: US-FDA Tag: IB-EN Draft Version: 2024-02-12 Instructions for Use: Device Model #: MT16W2 Product REF #: NCTG2 Introduction Document Scope Thank you for purchasing the NC° Thermometer (Gen2)! This instruction of Use contains important information about the device safety, performance, and operation.
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Page 2: Intended User
Instructions For Use Model No.: MT16W2 Region: US-FDA Tag: IB-EN Draft Version: 2024-02-12 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 Bluetooth 4.0 interface. - Page 3 Instructions For Use Model No.: MT16W2 Region: US-FDA Tag: IB-EN Draft Version: 2024-02-12 cause Internal Chemical Burns in as little as 2 hours. Seek immediate medical attention if a battery is suspected to be swallowed or inserted inside any part of the body.
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Page 4: Electromagnetic Compatibility Information
(2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications to the product are not approved by Microlife USA and could void the user's authority to operate the equipment under FCC jurisdiction. - Page 5 Instructions For Use Model No.: MT16W2 Region: US-FDA Tag: IB-EN Draft Version: 2024-02-12 Founder welcome card • Battery: CR2032 • Device Description Gold-plated measuring tip • Bluetooth button • Illuminated display • On/off button • Battery compartment • Device User Interface Display A.
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Page 6: Battery Installation
Instructions For Use Model No.: MT16W2 Region: US-FDA Tag: IB-EN Draft Version: 2024-02-12 If the device cannot connect to the app, it switches off after 60 seconds. If this occurs, check whether Bluetooth is enabled on your smartphone and that the Natural Cycles app is running. Now try to establish a connection again. - Page 7 Instructions For Use Model No.: MT16W2 Region: US-FDA Tag: IB-EN Draft Version: 2024-02-12 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.
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Page 8: Memory Full
Instructions For Use Model No.: MT16W2 Region: US-FDA Tag: IB-EN Draft Version: 2024-02-12 Memory Function Operation 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;... -
Page 9: Manual Data Transfer
Instructions For Use Model No.: MT16W2 Region: US-FDA Tag: IB-EN Draft Version: 2024-02-12 Manual Data Transfer If the measurements cannot be transferred to the Natural Cycles app immediately 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 later. - Page 10 Instructions For Use Model No.: MT16W2 Region: US-FDA Tag: IB-EN Draft Version: 2024-02-12 temperature and allow it to stabilize for at least 2 hours before using it. Fever warning. Temperature higher Not applicable for device trouble shooting. than 99.5℉ measured.
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Page 11: Cleaning And Disinfecting
Instructions For Use Model No.: MT16W2 Region: US-FDA Tag: IB-EN Draft Version: 2024-02-12 The device is in technical test mode. Switch it off and on again after a few seconds to return to normal mode. Device Maintenance & Disposal Cleaning & Disinfecting Clean the thermometer with a soft cloth and isopropyl alcohol diluted with water or cold, soapy water. -
Page 12: Technical Specifications
Instructions For Use Model No.: MT16W2 Region: US-FDA Tag: IB-EN Draft Version: 2024-02-12 Please contact: NaturalCycles Nordic AB St Eriksgatan 63b 112 34 Stockholm, Sweden help.naturalcycles.com www.naturalcycles.com Disposal Technical equipment and batteries do not belong to household waste. They must be disposed of at appropriate collection and disposal points. -
Page 13: Compliance Information
Instructions For Use Model No.: MT16W2 Region: US-FDA Tag: IB-EN Draft Version: 2024-02-12 Battery life: approx. 400 measurements Applied part: Type BF Electrical Protection Type: Internally powered ME equipment. Operation mode: Continuous operation Data transfer: Bluetooth 4.0 LE (low energy) Ingress Protection (IP) Rating: IP67: dust tight, protection against temporary submersion Expected service life: 5 years or 10,000 uses. -
Page 14: Symbols And Definitions
Instructions For Use Model No.: MT16W2 Region: US-FDA Tag: IB-EN Draft Version: 2024-02-12 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. -
Page 15: Manufacturer & Certification
Instructions For Use Model No.: MT16W2 Region: US-FDA Tag: IB-EN Draft Version: 2024-02-12 Applied Part: Type BF Manufacturer Warning Caution Temperature limitation Humidity limitation Unique Device Identifier Manufacturer & Certification Manufacturer: Microlife Corporation. 9F, 431, Ruiguang Road, Nei-Hu, Taipei, Taiwan, China...
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