MD/PRD/IN16.ANIMOC9 V.02 - 12/03/2020
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Never put sensors on skin injuries.
Using sensors other than those specified by Mdoloris Medical Systems can damage
the device or result in a risk of harm to the user or the patient.
Reusing a sensor could reduce adhesion, leading to a possible decrease in ECG
signal acquisition performance.
Reusing a sensor could reduce its adhesive strength due to an initial application,
withdrawal and a new application.
Performance warnings and cautions
The ANI MOC-9 may be used during electrosurgery, but this may affect the accuracy
or availability of the parameters and measurements.
The ANI MOC-9 may be used during defibrillation, but this may affect the accuracy or
availability of the parameters and measurements.
The ANI MOC-9 may be used during defibrillation; however, the display may require
up to 15 seconds to return to normal operation.
The ANI MOC-9 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.
Inaccurate ANI readings or no ANI readings may be caused by:
• Moisture on the skin.
• Excessive motion.
• Muscle activity
• Metal plate or other foreign object in sensor path.
• Electrosurgical interference.
• Improperly applied sensor.
• Adjacent placement of any sensor that is not connected to the same ANI
MOC-9.