DRKS00032633
Completed
N/A
Clinical investigation to validate the accuracy of ThermoFlash®Pro used by health care professionals under real-life conditions
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- As this is a medical device, we work according to ISO 80601-2-56 (2017). For thermometers, independent of disease
- Sponsor
- BIOSYNEX
- Enrollment
- 116
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed and dated informed consent
- •2\. Febrile and non\-febrile patients without any age restrictions
Exclusion Criteria
- •1\. Patients who have taken antipyretics in the preceding 120 minutes
- •2\. Patients with medical conditions which might skew Clinical Accuracy Validation results such as inflammation at the measuring site (e.g.: Barbiturates, thyroid preparations, antipsychotics, recent immunizations or intensive sports before the measuring)
- •3\. Current participation in an interventional clinical trial
- •4\. Employees of the sponsor or patients who are employees or relatives of the users
- •5\. Patient with injuries/skin disease at measuring site
- •6\. Pregnant or breastfeeding woman
- •7\. Patient under guardianship or curatorship
Outcomes
Primary Outcomes
Not specified
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