The information on this page is meant to inform all US based users of CORE, an innovative clinical thermometer, about its safe use and potential risks. As of October 6, 2020, the CORE Medical Temperature Monitoring System does not require a formal EUA pre-launch review process at this time and may be marketed in the USA in support of this current Public Health Emergency (COVID-19) in accordance with the current FDA guidance and requirements.
CORE used as a medical thermometer should be used by individuals to self-monitor their core body temperature in both clinical and non-clinical settings. The CORE thermometer can either be worn with medical-grade adhesive patches (see right picture) or by clipping it onto any heart rate monitor (HRM), chest strap, arm strap (see picture left) or even by attaching it to bras. With proper body placement, the CORE thermometer allows for highly accurate core body temperature monitoring (within ±0.21°C / ±0.36°F).
The CORE thermometer connects to a user supplied smart phone using a standard Bluetooth protocol. The CORE thermometer also has an integrated alarm function, which warns the user when crossing a user defined core body temperature threshold. Furthermore, our new clinical thermometer is capable of recording data for up to 48 hours, even if it is not connected to the smart phone. Data download is currently not enabled for CORE.
The CORE thermometer is not intended to replace any primary temperature screening processes utilizing FDA approved medical thermometers. However, CORE is an ideal supplement to routine medical grade temperature screenings, such as those conducted prior to admission, or dismissal from/to any facility, building or regulated public areas.
The CORE device is only for sale and use under the Food and Drug Administration’s Emergency Use Authorization provisions (COVID-19).
FACT SHEET FOR HEALTHCARE PROVIDERS AND PATIENTS
As set forth in the EUAs, the following fact sheets for patients and healthcare providers is to be provided as additional information and as a package insert supplement to the labeling for US customers. The following information contains warnings for all US based users of CORE and contains safe use guidelines and information regarding potential risks and hazards:
- Do not attempt to clean or sanitize CORE device in any other manner than set out in the "Maintenance" section of the CORE Important Product Information document.
- Do not expose CORE device to direct sunlight or excessive heat. The recommended operational temperature range is between 10 and 40°C (55-104°F).
- Do not use CORE if any of the conditions apply which are specified in the "Device Warnings" section of the CORE Important Product Information document.
- The sensor should be free of visible defects, discoloration, and damage. If the sensor is discolored or damaged, discontinue use. Never use a damaged sensor or one with exposed electrical circuitry.
- Only use CORE as directed in the instructions provided in the CORE Important Product Information document.
- Do not use CORE in any manner other than that specified in the CORE Important Product Information document. Do not attempt to measure a person's body temperature in another body location other than those specified in the official supporting documentation of CORE.
- Note that alteration at the skin surface such as oils, make-up or tattoos may cause inaccuracies in temperature estimation.
- User’s with known skin conditions or sensitive skin should avoid using the medical grade adhesive patches. If a user experiences irritation as a result from using the medical grade adhesive patches, they should immediately remove the patches from the body and only use CORE with either a heart rate belt, chest strap or arm strap.
- CORE should not be used to measure a person's body temperature instantaneously and in no way is intended to replace routine temperature screening. The user must be aware that CORE has a thermal equilibration time (time needed to acquire a stable reading) of up to 5 minutes before it can display the user's body temperature accurately.
- Accuracy of temperature estimation can be affected by profuse sweating, superficial wounds or injury at the measurement site.
- The back side of CORE device must be kept clean and intact. Any damage, dust or dirt can result in an erroneous temperature reading and might cause skin irritations.
- In case water enters the CORE device, do not use or attempt to charge the device and contact your dealer immediately for technical service.
- Do not use CORE device in any environment with a strong electromagnetic field.
- Handle CORE device with care and avoid any physical percussion such as knocking the device against hard surfaces or dropping it. Do not use CORE device if damaged or not in proper working condition.
- Users of CORE should be aware that, in the case of elderly people (≥65 years old), the temperature detected may be lower than the actual body temperature.
- CORE device shall not be used by children without the supervision of an adult. Keep the CORE out of the reach of children or persons with limited sensorimotor skills. Small parts may be ingested or inhaled.
- Use of the CORE device does not substitute for professional medical consultation as the CORE is not an FDA approved medical device. Tell your physician what type of thermometer you are using and where on the body the temperature reading was taken.
- Note that there is no single "normal" temperature which is valid for everyone. Individual temperature varies according to factors including, but not limited to, a person’s sex, BMI, age, outside temperature, and physical conditions.
- The CORE device has not been formally tested on pregnant individuals. Temperature patterns may deviate from the user's "normal" temperature range, in a non-pregnant state
- Due to thermoregulatory processes of the body, a person's CORE temperature does not increase evenly throughout the body. For this reason, it can take up to 1 hour for CORE to report changes in body temperature.
- In the event that the CORE app is closed, CORE device is equipped with enough internal storage to buffer temperature data up to 48 hours.
- Failure to observe above-mentioned precautions may lead to either overestimated or underestimated body temperature readings.
- CORE is not a medical device and cannot be used for medical diagnoses. Note that CORE cannot be used as a replacement for the standard of care, but CORE is a perfect supplement to routine medical grade temperature screenings, such as those conducted prior to admission, or dismissal from to any facility, building or regulated public areas.
- Note that physical exertion can elevate the body temperature. Any misinterpretation of body temperature readings by the user as well as any actions taken as a result of this misinterpretation, cannot be attributed to product malfunctions.
- Note that the CORE device and CORE app are subject to frequent updates. Users of CORE are responsible for regularly updating their CORE device and CORE app to their respective latest versions.