The Finapres Nova is used in a professional medical environment (i.e. hospitals,
clinics and research institutions etc.). The Finapres Nova is suitable for use in an
operating room in the non-sterile zone. The Finapres Nova is not intended for use
in an oxygen rich environment.
The Finapres Nova should not be used in combination with systems
that can cause electromagnetic interference. This includes devices
such as defibrillators, MRI’s, or electro-surgical units
1.3 Intended user
The user of the Finapres Nova should be a qualified operator. The operator should
have knowledge of the system and data interpretation, obtained via medical
education, system manuals and/or specific courses. He/she is the person
operating the Finapres Nova instrument.
1.4 Intended patient population
Age
18 years and up
Weight
20 up to 255 kg
Health
With respect to the measurement principle it is known that the application of the
device in patients with Raynaud’s disease is limited.
Condition
Provided the device can detect a sufficient pulsating artery (according to its own
acceptance criteria) and the finger cuff is applied correctly, the measurement can
be performed.
The Finapres Nova can be used with pregnant, pre-eclamptic patients with
caution.
Diagnosis
The device has an added value for diagnosing a patient. However, an
uninterrupted availability of measurement data cannot be guaranteed. Therefore,
in situations where this is required additional patient monitoring equipment is
needed.
Contraindications
Not known.
1.5 Device classification
The Finapres Nova is class I ME equipment according to IEC 60601-1.
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