Temp Screening Assistant for Misty II Safety Information

Important Safety Information: Save These Instructions

Warning: When using an electrical appliance, basic precautions should always be followed, including the following: READ ALL INSTRUCTIONS.

Warning: To reduce the risk of injury or damage, read and follow the safety precautions in this Legal Guide, in the Misty II Reference Manual, and the Temp Screening Assistant for Misty II User Guide both located at www.mistyrobotics.com/support/manuals when setting up and maintaining your Misty II robot and Temp Screening Assistant for Misty II.

United States FDA Notices:

  • The Temp Screening Assistant (which consists of a Misty II Robot with Integrated Thermal Imaging Camera Visor, Temp Screening Assistant Software, and blackbody Temperature Reference Device) is intended for initial body temperature measurement FOR TRIAGE USE ONLY and the temperature measurements delivered should NOT BE solely or primarily relied upon to diagnose or exclude a diagnosis of COVID-19, or any other disease.
  • Indication of elevated body temperature measured by the Temp Screening Assistant should be confirmed with secondary evaluation methods, such as a clinical grade contact thermometer.
  • The Temp Screening Assistant should be used to measure only one person’s temperature at a time.
  • Use the Temp Screening Assistant ONLY with the Misty Temperature Reference Device when utilizing temperature measurements.
  • The Temp Screening Assistant IS NOT FDA approved or cleared. This product aims to follow the guidelines issued by the FDA here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-telethermographic-systems-during-coronavirus-disease-2019-covid-19-public-health

Note
The explanations provided in this guide are for informational purposes only and may be modified by Misty Robotics at any time. The most current version of this Legal Guide can be found at www.mistyrobotics.com/legal. Additional warnings, cautions, notes, disclaimers, and information can be found in the Misty II Reference Manual and/or Temp Screening Assistant for Misty II User Guide.

Safety and Handling:
Store and operate your Temp Screening Assistant hardware (Misty II with thermal camera visor and Misty Temperature Reference Device) in room temperature environments only as extreme temperatures could damage it. DO NOT disassemble the Misty II visor or the associated Misty Temperature Reference Device temperature calibration source; doing so could cause electric shock, burns, or other safety risks. Never place your Misty II or Misty Temperature Reference Device in water, nor place the Misty Temperature Reference Device’s charging source in or near water as significant risk of electrical shock to yourself or others and damage to the product and chargers is possible. Avoid getting water on or near the Misty Temperature Reference Device charging brick. To reduce the risk of damage or injury, do not attempt repairs to the Misty II’s visor or Misty Temperature Reference Device. Attempting to service the Misty II visor or Misty Temperature Reference Device yourself will void any applicable warranty and may result in expensive repairs and or calibrations. For all other servicing questions see our website at www.mistyrobotics.com/support or contact us at [email protected] or 1-720-370-4912. Always disconnect your Misty Temperature Reference Device from its power supply cord before cleaning or maintaining it. Do not place your Misty Temperature Reference Device on an unstable base or unstable flooring as it could fall over and cause physical harm to a person in the area or damage the Misty Temperature Reference Device. For additional information, see “Important Safety and Handling Information” in the Misty II Reference Manual and Temp Screening Assistant for Misty II User Guide.

Use
Additional information about how to properly use and calibrate the Temp Screening Assistant is available in the Temp Screening Assistant for Misty II User Guide. This information includes: (a) performance specifications and the methodology and frequency of any calibration needed to maintain the labeled specifications; (b) how to position a person for use with the thermal imaging to make a temperature measurement to within the stated device accuracy; (c) description and purpose of the blackbody reference source (used for thermal drift compensation) and its importance in obtaining an accurate temperature assessment; (d) the reference body site used for temperature estimation; (e) how different environmental and system setup factors can affect the measurement, including the body site chosen for measurement, the condition of the screening site (e.g., screening background, ambient temperature and humidity, airflow); (f) different factors to consider in the design of the facility protocol (e.g., installation, viewing angle, blackbody temperature reference source); (g) the installation procedures and qualification testing that should be performed during installation or when imaging equipment is being relocated; and (h) the appropriate imaging distance based on the spatial resolution and performance of the device.

MISTY ROBOTICS DOES NOT GUARANTEE THAT THE TEMP SCREENING ASSISTANT IS ERROR-FREE OR BUG FREE OR THAT IT WILL DETECT ELEVATED TEMPERATURES WITHOUT FAIL. THE TEMP SCREENING ASSISTANT SHOULD NOT BE RELIED ON IN PLACE OF OTHER PUBLIC HEALTH MEASURES RECOMMENDED BY PUBLIC HEALTH OFFICIALS AND THE CENTERS FOR DISEASE CONTROL AND PREVENTION, SUCH AS SOCIAL DISTANCING AND WEARING FACE COVERINGS.

Health Considerations
Neither the Misty II visor nor the Misty Temperature Reference Device are a toy and are not intended to be used by children; babies and small children as well as pets should be supervised when Misty II or the Misty Temperature Reference Device are operating. For a list of several other important health matters see “Health Considerations” in the Misty II Reference Manual.

This equipment IS NOT FDA APPROVED. However, it does follow the FDA guidelines for thermal imaging systems used during Covid 19 Public Health Emergency. As per the FDA recommendations, it utilizes a blackbody temperature reference source, the Misty Temperature Reference Device.

Recycling
Contact Misty Robotics or your authorized reseller/distributor from whom you purchased your Misty II for instructions on how to recycle your Misty II.

Misty Robotics One-Year Limited Warranty
This Misty II (with thermal camera visor) and Misty Temperature Reference Device, except for the motors, as supplied and distributed by Misty Robotics or its authorized resellers/distributors and delivered new, in the original carton to the original purchaser, is warrantied by Misty Robotics to the original purchaser against manufacturing defects in materials and workmanship for a period of one (1) year. The specific terms of the Limited Warranty can be found online at https://www.mistyrobotics.com/legal. To request a free written copy of the Temp Screening Assistant for Misty II Limited Warranty, please contact us at [email protected], 1-720-370-4912 or 5305 Spine Rd., Unit E, Boulder, CO 80301.

Software
Your Misty II robot and Misty Temperature Reference Device uses proprietary Misty Robotics copyrighted software to control its operation. Parts of this software may contain copyrighted elements that are licensed under the GPL, MIT, and Creative Common licenses, among others. Additionally, your Misty II robot and Misty Temperature Reference Device contain proprietary firmware developed and copyrighted by Misty Robotics. Any software contained in your Misty II robot and Misty Temperature Reference Device is licensed, not sold. Please refer to the Misty Robotics End User License Agreement at www.mistyrobotics.com/legal for details. For the terms of use of Misty Robotics programming interfaces, see “Developer Terms” at www.mistyrobotics.com/legal.

Support
You may contact Misty Robotics for support questions at [email protected], call 1-720-370-4912, or visit our website at www.mistyrobotics.com/support.

Regulatory
Both the Misty II thermal camera equipped visor and the Misty Temperature Reference Device, and the combination of the two ARE NOT FDA APPROVED. No health-related activity that would rely on such FDA approval should be performed or undertaken with the Misty II visor or Misty Temperature Reference Device. The Misty II visor and Misty Temperature Reference Device are intended for initial body temperature measurement for triage use only and the temperature measurements delivered should not be solely or primarily relied upon to diagnose or exclude a diagnosis of COVID-19, or any other disease.

Contains FCC IDs: Misty Temperature Reference Device Embedded Bluetooth module FCC ID: T9JRN41-1

Transmit Frequency:
BLE 4.0 (2402MHz – 2480MHz)

© Misty Robotics, Inc.; Misty Robotics and the Misty Robotics logo are all registered trademarks of Misty Robotics Inc. Temp Screening Assistant for Misty II and Misty Temperature Reference Device are trademarks of Misty Robotics, Inc. All rights reserved. Patents pending. Other trademarks and trade names are those of their respective owners. For more information about Misty II, visit us at www.mistyrobotics.com.

Designed in Boulder, Colorado – Assembled in China

Misty Robotics, 5305 Spine Rd., Unit E, Boulder, CO 80301, USA