baxter Starling - Limitations of Use; Clinical Situations Potentially Affecting Starling Algorithm Accuracy or Performance

2-4 Starling Monitor - User Guide
Indications for Use
The Starling with NIBP and SpO2 functionalities is intended for use within hospitals and other
healthcare facilities (e.g., outpatient clinics) that provide patient care.
Limitations of Use
Clinical Situations Potentially Affecting Starling Algorithm Accuracy or Performance
Note Most of the clinical situations and patient conditions listed below may impact absolute values but
should not affect device responsiveness and sensitivity/specificity to assess directional
hemodynamic changes. The exception is in circumstances of severe external pacemaker interference.
Examples of conditions that can influence reported Cardiac Output (CO), influence monitor
accuracy, or result in suboptimal signal quality are shown below.
1. Severe aortic insufficiency
The regurgitation fraction associated with severe cases of aortic insufficiency may
result in overestimation of the net forward CO. That is because the Starling measures
the ejection but does not subtract the backward regurgitation that takes place during
diastole.
2. Severe anatomic abnormalities of the thoracic aorta
Severe anatomic abnormalities of the thoracic aorta, such as a large synthetic aortic
graft, large aortic aneurysm or large aortic dissection can impact the accuracy or
performance of hemodynamic parameters. The abnormality has to be large in order to
have a meaningful impact on monitor accuracy.
3. External pacemakers and internal pacemakers with unipolar electrodes
Use caution in monitoring patients with external pacemakers, and patients with
relatively older models of internal pacemakers which utilize unipolar electrodes. Some
external pacemakers and unipolar internal pacemakers can add electrical artifact to
the Starling Bioreactance signal.
Note It is possible to completely mitigate or significantly alleviate the problem by placing the Starling
Sensor 2.5 inches (approximately 6 cm) or more away from the external pacemaker percutaneous
lead. Unipolar internal pacemakers are rarely used today.