M
anatec
B
iomedical
21, Rue du stade, Petit Ebersviller
▪
57730 Folschviller
▪
France
Tél : +33 (0)3 72 82 50 00
▪
Fax : +33 (0)1 30 74 46 48
Service Manual PhysioFlow Lab1
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Version of Monday, 10 July 2017
Definitions
Patient Environment
Any area in which intentional or unintentional contact can occur between
a patient and parts of the PhysioFlow® system or between a patient and
other persons touching parts of the PhysioFlow® system. For the
PhysioFlow® application, it equates to a 1.5m distance around the patient
himself or of the surface he is in contact with (in any direction).
Conditions of Use
The PhysioFlow® Lab1 is a noninvasive hemodynamic evaluation system using analysis of trans-thoracic
bioimpedance signals. The system can be used at rest or while exercising to assess the patient’s
cardiovascular state.
The PhysioFlow® devices are intended to place the computer out of the patient environment (cf.
“
Definitions”
section).
If the operator has to install/use the computer within the patient
environment, the computer needs to have a medical grade (Comply with
IEC 60601-1 standard).