U-TruSignal SpO2 Testing in Neonates

The purpose of this study is to collect blood samples from neonates under normal clinical conditions to ensure proper function (clinical performance) with the U-TruSignal device.

The study will include both the TruSignal AllFit Sensor and TruSignal Sensitive Sensor.

After providing consent, no preparation beyond the investigational site's standard of care is required before study procedures begin. At the start of the procedure, one to two sensors, upon the discretion of the investigator, shall be applied to the subject.

The duration of the subject's participation in the study is dependent upon the scheduled routine arterial blood draw and obtaining the maximum of 6 data pairs (3 data pairs per sensor). The Investigator or designated study staff will collect of SpO2 and pulse rate for each study subject. Laboratory results from arterial blood draw will be collected from the hospital's medical records. The description, severity, and device relatedness of any AE or SAE during the study will be recorded.

Inclusion criteria

• Parents or legally authorized representative (LAR) can understand and provide written informed consent; AND
• Subjects are < 29 days old, and requiring arterial blood samples per the site's standard of care.

Exclusion criteria

• Neonates with injuries, deformities or abnormalities may prevent proper application of the sensor;
• Neonates with inadequate heart pump function affecting blood circulation caused by identified cardiac or cardiovascular conditions such as patent ductus arteriosus, persistent pulmonary hypertension, septal defects, or congenital heart disease;
• Neonates with mean arterial blood pressure < 20mmHg;
• Neonates with congenital diaphragmatic hernia; OR
• Neonates under High frequency ventilation therapy.