Official user guide of TAURI Temperature Check Tablet
FDA Compliant in accordance to the Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 Public Health Emergency.
SETTING UP TAURI
Factors to consider when installing and setting up TAURI such as environment, facility protocols, installation.
A summarized report of the necessary procedures TAURI has taken to become a FDA
TAURI is FDA compliant and in accordance to the Enforcement Policy for Telethermogrphic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency-consistent to the guidelines in ISO/TR13154:2017: Medical electrical equipment- Deployment, implementation and operational guidelines for identifying febrile humans using a screening thermograph.
TAURI is used to estimate the temperature at a reference body site during a triage process. TAURI is NOT intended for a medical purpose and is not a medical device, it is NOT intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease.
Visual Heat Map patterns are only intended for locating the points from which to extract thermal measurement. TAURI has a measurement error of +/- 0.3 degree Celsius and at an appropriate distance of 0.5 to 1 meter.
The current sensor array is 32 x 32, each sensor point measures an independent temperature that reflects to the heat map.
SETTING UP TAURI
Factors to consider during setup
The infrared camera of TAURI should be positioned perpendicular, both horizontally and vertically to the face of the individual being screened.
The individual being screened and the external temperature reference source should be in the correct position and orientation relative to the camera for proper focal distance, depth of field and image capture. There should be a means of ensuring that the individual being screened is in this proper position e.g. a stool, marks on the floor. Consideration should be given to individuals in wheelchairs.
The backdrop behind the individual being screened and where TAURI is utilized should be thermally uniform, non-reflective in the IR spectrum, and not dark in color in the visible spectrum (closer to white than black).
The operator should be positioned with a clear visual field of the individual being screened and the display of TAURI. The operator may need to intervene to correct the individual’s position. The operator should also be positioned in such a way as to divert individuals to the secondary screening area when required.
Environmental factors to consider
The area chosen for screening should have a non- reflective background and minimal reflected infrared radiation from the surroundings. Reflective background such as glass panels should be avoided or covered with opaque materials. Unwanted sources of infrared radiation such as sunlight, heaters, electrical sources and strong sunlight (e.g. incandescent, halogen, quartz tungsten halogen) should be avoided at the screening area, particularly within the field of view of the camera of TAURI.
The environment in which the individual is being screened can affect the skin temperatures. The temperatures measured by TAURI can be influenced when the screening subject is sweating. Sweating thresholds can vary according to a person’s fitness level, environment of residence, length of adaption and the relative humidity. When humidity is controlled, these effects are minimized. To produce consistent and reliable results of the temperature screening process, it is imperative that TAURI be situated in a stable room temperature with a relative humidity range from 10% to 50% These conditions can best be achieved by creating a local, controlled environment.
Factors to consider on design of Facility Protocol
To facilitate an effective screening operation, trained operators are stationed near TAURI to observe the temperature of the individual being screened. TAURI is intended to be used as a reference device to detect elevated temperature. A raised temperature should be confirmed by temperature measurement using a clinical thermometer compliant with ISO80601-2056. Any confirmed cases of raised temperature should be handled according to established medical protocols. It is important to recognize areas of bottlenecks and deploy this equipment appropriately.
Factors to consider during Installation
LOCATION: TAURI should be positioned near the entrance of the facility. The secondary screening area should be at a tangent to TAURI area, but removed from the general traffic flow. Screening near the entrance of the facility prevents commingling. The secondary screening area is a care area that should be equipped with a clinical thermometer and accessories that comply with ISO 80601-2-56 and should be staffed by qualified medical personnel.
ADEQUATE SOURCE OF SUPPLY MAINS: Since TAURI can have a prolonged stabilization period prior to being ready for use, consideration should be given to a means of providing a reliable source of supply mains. Even a short transient loss of supply mains or start up can cause a 30 min to 40 min delay in the availability of use. Such delays can cause a significant disruption in the flow of traffic.
LIGHTING: The ambient visual light level should be adequate for the operator to determine that the individual being screened is properly positioned and free from obstruction. The lighting source should not produce significant IR emissions, as those can interfere with TAURI. If visual imaging is provided, the light level should be adequate for image quality.
SOURCES: Thermal sources either hot or cold, need to be avoided in the area around TAURI. Sun facing windows, radiant heaters or sources of cold (cold windows or outside walls) can interfere with TAURI. The traffic layout should be designed to channel the traffic into a single file prior to entering each TAURI area. Toilets should not be proximal to the screening area to inhibit potential cross-infection.
HUMIDITY AND TEMPERATURE: The area leading to TAURI and the immediate area around TAURI should be maintained at a humidity level below 50% and a room temperature to minimize the effects of elevated humidity and ambient temperature, which can produce sweating. Significant convective airflow should be avoided in TAURI.
Glory Star will continuously update this user guide.
1. FDA recommends that devices use labeling that help users better understand the device
The labeling includes a prominent notice that the measurement should not be solely or primarily relied upon to diagnose or exclude a diagnosis of COVID-19, or any other disease. The labeling includes a clear statement that: Elevated body temperature in the context of use should be confirmed with secondary evaluation methods ( e.g. an NCIT or clinical grade contact thermometer);
The labeling includes a clear statement that: Elevated body temperature in the context of use should be confirmed with secondary evaluation methods ( e.g. an NCIT or clinical grade contact thermometer);
Label on TAURI
"Tauri Temperature-Check Tablets are not intended not designed to diagnose or detect medical conditions including, but not limited to, viruses or other illnesses. In the event that an elevated skin temperature is detected, the subject should be advised to check temperature with an approved medical thermometer and the finding confirmed. Absence of an elevated skin temperature does not preclude a fever."
2. Public health officials experience with device in environment of use
Public health officials, through their experience with the device in the particular environment of use, should determine the significance of any fever or elevated temperature based on the skin telethermographic temperature measurement;
It is important to understand that SKIN TEMPERATURE does not solely depend on body core temperature and can be affected by other physiological factors and environmental factors. Public health officials should determine the significance of any fever or elevated temperature.
3. Measure one subject's temperature at a time
The technology should be used to measure only one subject’s temperature at a time;
TAURI temperature check tablets only measure one person’s temperature at a time.
The Tauri Temperature-Check Tablets are designed to detect temperature anomalies. It’s important to understand there are many factors, including environmental and physiological that can impact a person’s surface temperature reading. Skin surface temperature vs actual core body temperature may differ either way. The Tauri Temperature-Check Tablets must be operated in accordance with the manufacturer’s user guide.
Tauri Temperature-Check Tablets are not intended not designed to diagnose or detect medical conditions including, but not limited to, viruses or other illnesses. Tauri tablets should only be used to detect variations in surface temperature.
In the event that an elevated skin temperature is detected, the subject should be advised to check temperature with an approved medical thermometer and the finding confirmed. Absence of an elevated skin temperature does not preclude a fever. It is important to understand that skin temperature does not solely depend on body core temperature and can be affected by other physiological factors and environmental factors. TAURI is designed to test one subject’s temperature at a time.