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

Status Enrolling by invitation

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Febrile Illness

Clinical Trial Details

NCT number	NCT06056011
Study type	Interventional
Source	Baxter Healthcare Corporation
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	February 19, 2024
Completion date	December 15, 2024

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