When Not To Use Finometer® Model-2; Avoiding Injury To Subjects And Personnel - FINAPRES Finometer Model-2 User Manual

measurement of accurate absolute blood pressure data, but provides
optimal trending of blood pressure data.
Modelflow built-in calibration is useful from 18 years on. Cardiac output
measured with this device under the Modelflow model requires a
calibration with thermal dilution.
The physiological parameters provided by the device have clinical
significance only if determined by a physician and should not be used
as the sole means for a subject's diagnosis.
The data provided by the device can be further processed by the
included PC-based BeatScope® software.
When not to use Finometer® Model-2
When 100% availability of arterial pressure is required in critically ill
subjects since treatment depends on it, and other means are available,
Finometer® Model-2 is not the preferred choice. Still, in two studies
we found that the overall percentage availability of Finapres in the
operating room during coronary artery bypass grafting (Wesseling3)
and of Portapres in 24 hour ambulatory recordings (Imholz2) was
equal to that of the intra-arterial lines. The finger is a distal measuring
site and smooth muscle in the arteries and arterioles of the circulation
of hand and finger can come to full contraction. An extreme example of
this is Raynaud's phenomenon. Measures have been built into
Finometer® Model-2 to alert the user to such conditions developing.
When full contraction does occur finger pressure measurement is no
longer possible, and cannot be restored quickly.

Avoiding injury to subjects and personnel

• (USA) Federal law restricts this device to sale by or on the order of
a physician. This device is intended for use by trained health care
professionals.
• The physiological parameters provided by this device have clinical
significance only if determined by a physician and should not be
used as the sole means for determining a subjects diagnosis.
Finometer® Model-2 7
User's Guide