Masimo LiDCO - Performance Warnings and Cautions

Masimo LiDCO Safety Information, Warnings and Cautions
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 Do not use device if it has been exposed to more than just vertical dripping fluids.
WARNING: To ensure safety, avoid placing anything on the device during operation.
WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of
patient entanglement or strangulation.
WARNING: All cables are designed for use with specific devices. Verify the compatibility of the device
and cable before use; otherwise, degraded performance and/or patient injury can result.
WARNING: Do not place Masimo LiDCO where the controls can be changed by the patient.
WARNING: To ensure patient electrical isolation, all external device connections to the output interface
connector must be done using only authorized data cables.
WARNING: Make sure Masimo LiDCO is securely mounted, and that all accessories and cables are
appropriately arranged to minimize the risk of injury to patients, users or the equipment.
WARNING: Before use, check the patient notes for the presence of aortic valve regurgitation. Masimo
LiDCO may be inaccurate in such patients.
Performance Warnings and Cautions
WARNING: Masimo LiDCO is intended only as an adjunct device in patient assessment. It should not be
used as the sole basis for diagnosis or therapy decisions. It must be used in conjunction with clinical
signs and symptoms.
WARNING: Masimo LiDCO may be used during electrocautery, however this may temporarily affect the
accuracy or availability of the parameters and measurements.
WARNING: The scaling factor estimate cannot be as precise as an independent calibration of the LiDCO
algorithm with a well-performed indicator dilution measurement.
WARNING: Before use, check the patient notes for the presence of aortic valve regurgitation. The
Masimo LiDCO may be inaccurate in such patients.
CAUTION: If any measurement seems questionable, first check the patient’s vital signs by alternate
means and then check Masimo LiDCO for proper functioning.
CAUTION: Do not place Masimo LiDCO on electrical equipment that may affect the device, preventing it
from working properly.
Note: The Calibration Factor estimate used has boundary conditions similar to any device using a
nomogram-based approach to estimate physical characteristics. Individual patient history may include a
variety of potentially confounding conditions such as chronic hypertension, arteriosclerosis and/or
diabetes, which may alter aortic capacitance.
Note: Care should be taken when using Masimo LiDCO in patients with severe peripheral
vasoconstriction due to pre-existing disease or because of vasoactive drug treatment. In these cases, the
radial artery pressure may be substantially different to the central aortic pressure.
Note: Dynamic preload response variables (e.g. SVV or PPV) are only valid in patients with closed
chests on full mode control ventilation.
Note: Dynamic preload response variables (e.g. SVV or PPV) are unreliable in patients with significant
arrhythmia.
Note: Use and store Masimo LiDCO in accordance with specifications. See the Specifications section in
this manual.