Timmy3 Module Clinical Accuracy ISO 80601-2-56:2017 + A1 2018

TIMMY3 80601-2-56:2017 + A1 2018 Clinical Accuracy Study

The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module, integrated into host device CVSM, according to ISO 80601-2-56:2017 + A1 2018.

The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module, integrated into host device CVSM, according to 80601-2-56:2017 + A1 2018.

This study is designed to provide supporting documentation for the TIMMY3 module operating with SureTemp Plus algorithms. Testing will be performed with a production equivalent CVSM modified to use TIMMY3 (TIMMY3 investigational device), running the SureTemp Plus algorithms. The TIMMY3 module is intended to be integrated into additional Welch Allyn devices such as, but not limited to, the Connex Spot Monitor and Spot 4400. The process described below will be followed in accordance with the method called out in ISO 80601-2-56:2017 + A1:2018.

Inclusion Criteria:

• Study subjects (person who is having their temperature taken) must meet the following criteria to participate in this study:

  • Subjects that are minors must provide assent to the clinical site's policy (if approved by Baxter) and/or the study sponsor's policy to participate in the study.
  • Subject or the legally authorized representative (LAR) must sign the informed consent form in order for the subject to participate.
  • Subject must be willing and able to comply with the study procedures.
  • Age: normal weight (full-term) newborn to adult
  • The study subject is in ambient temperature for at least 20 minutes prior to participating.
  • The study subject is able to have their temperature taken for up to six minutes for multiple rounds of temperatures per anatomical site.
  • The study subject is not physically or emotionally agitated/uncooperative.
  • The study subject or legal guardian speaks/understands fluent English.

Exclusion Criteria:

• Study subjects (person who is having their temperature taken) are excluded if they meet any of the below criteria. Any subject that withdraws from the study will be replaced.

  • The study subject has anatomical abnormalities that would affect temperature.
  • The study subject has any known contraindication to oral, axillary, or rectal temperature measurements.
  • The subject is not alert or unable to follow simple commands such as closing one's mouth completely around the probe if an oral reference temperature is being taken.
  • The study subject has consumed food or drink, or smoked, within the last 20 minutes. The subject may be included if they wait 20 minutes prior to taking oral temperature.
  • The study subject has engaged in strenuous or semi-strenuous activity within the last twenty minutes (i.e., running, weightlifting, etc.).
  • Subject has taken antipyretics (Aspirin, acetaminophen, ibuprofen) in the preceding 120 minutes.
  • Subjects has medical conditions such as inflammation at the MEASURING SITE (Barbiturates, thyroid preparations, antipsychotics, recent immunizations).
  • Neutropenic immunocompromised patients, in whom rectal manipulation may seed the blood with bacteria.

Note: The study subject will be excluded if the reference temperature does not stabilize after the 3 -5 minute monitoring time.