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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Febrile Illness

Intervention / Treatment
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* Device: Connex CSVM with Timmy3 module


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Study subjects (person who is having their temperature taken) must meet the following criteria to participate in this study: Subjects that are between 7 and 17 years of age must provide assent to participate in the study. Subjects must be able to provide an informed consent or have legally authorized representative consent 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 study subject or their legally authorized representative (LAR) refuses to allow the study subject to participate for any reason. 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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Temperature Measurement<br>Oral temperature measurements for subjects age Group C as 5 years or older. Both febrile and non-febrile subjects included in this arm. | Device: Connex CSVM with Timmy3 module<br>* Connex Vital Signs Monitor with the Timmy3 Investigational module<br>|
| Experimental: Axillary Temperature Measurement<br>Adult Axillary temperature measurement supports age Group C where C contains 18 years and older subjects. Pediatric Axillary temperature measurement supports newborn to 5 years and less than 18 years old. Both febrile and non-febrile subjects included in this arm. | Device: Connex CSVM with Timmy3 module<br>* Connex Vital Signs Monitor with the Timmy3 Investigational module<br>|
| Experimental: Rectal Temperature Measurement<br>Rectal temperature measurements for all age groups (newborn to subjects older than 18 years of age) with no restrictions. Both febrile and non-febrile subjects included in this arm. | Device: Connex CSVM with Timmy3 module<br>* Connex Vital Signs Monitor with the Timmy3 Investigational module<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate the Clinical Accuracy of the Timmy3 thermometer algorithm | All age groups in the oral, adult and pediatric axillary, and rectal temperature modes. Clinical accuracy will include measurement of clinical bias, with its limits of agreement, and clinical repeatability as defined by the ISO 80601-2-56:2017 + A1:2018. | Up to 2 years |