Cautions In Using Finometer® Model-2; When To Use Finometer® Model-2 - FINAPRES Finometer Model-2 User Manual

6 Finometer® Model-2
Cautions in using Finometer® Model-2
• Direct finger arterial pressure is not within the ANSI/AAMI SP10
standard. Inverse filtering and level correction improve bias and
precision and are automatically applied in the default configuration,
but systolic precision is still below that required for blood pressure
diagnostics.
• Finometer® Model-2 should not be used without interruption for
periods longer than four (4) hours on a single finger in awake
subjects.
• The only mode of measuring blood pressure levels in compliance
with the recommendations of the ANSI/AAMI SP10 standard is
when the device is used with the return-to-flow method of
calibration, as available in Finometer® Model-1 only.
When to use Finometer® Model-2
The Finometer® Model-2 is a non-invasive instrument to measure
blood pressure in the finger of a human subject. Since it is non-
invasive, application is associated with little risk.
The Finometer® Model-2 is intended to be used when there is a need
for a non-invasive hemodynamic monitor. The Finometer® Model-2
provides a non-invasive characterization of the arterial circulation and
its beat-to-beat variability in pressure and flow as well as in various
hemodynamic parameters derived from these pressure and flow
signals. The device does not report any diagnosis but provides
numerical values. It is the physician's responsibility to make proper
judgments based on these numbers.
The non-invasively blood pressure waveform is measured by using the
Finapres method of Peñáz/Wesseling. Cardiovascular parameters
include cardiac output and total peripheral resistance based on the
Modelflow method of Wesseling.
The Finometer® Model-2 is intended to be installed and operated by a
qualified physician or operator. Pressure measurements are validated
for subjects above 18 years of age.
The device, equivalent to the Finapres device, is not equipped with the
return-to-flow method of calibration and does not allow for the
User's Guide