NCT06056011

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 373 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 1 Day – 99 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Febrile Illness

Interventions

Type	Name	Description
DEVICE	Connex CVSM with Timmy3 module	Connex Vital Signs Monitor with the Timmy3 Investigational module

Timeline

• Start date: 2024-02-19
• Primary completion: 2025-03-18
• Completion: 2025-03-18
• First posted: 2023-09-28
• Last updated: 2026-03-11
• Results posted: 2026-03-11

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study