Valve Test; Re-Implantation; Pressure-Flow-Characteristics - MIETHKE proGAV 2.0 Mode D'emploi

proGAV ® 2.0

VALVE TEST

Preoperative valve test
The most careful way of filling the valve is by
aspiration through a sterile single-use syringe
attached to the distal end of the catheter.
The distal end of the valve is connected and
immersed in a sterile physiological saline solu-
tion. The valve is patent if saline solution can be
extracted (fig. 15).
CAUTION
Contamination in the solution used for test-
ing can impair the product's performance.
Fig. 15: Patency test
WARNING
Pressurisation by the single-use syringe
should be avoided both at the proximal and
the distal end (fig. 16).
Fig. 16: Avoidance of pressurisation
Postoperative valve test
The proGAV 2.0 has been constructed as a reli-
ably functioning unit without pump or test func-
tion. The valve test can be performed by flush-
ing, pressure measurement or pumping.

RE-IMPLANTATION

Under no circumstances should products that
had previously been implanted in a patient be
subsequently reimplanted in another, because
a successful decontamination of the device
cannot be reached without functional degrada-
tion.
INSTRUCTIONS FOR USE | EN

PRESSURE-FLOW-CHARACTERISTICS

Horizontal valve position
The pressure flow characteristics of the
adjustable differential pressure unit in the pro-
GAV 2.0 are shown as an example for pres-
sure levels 0, 10 and 20 cmH O in the horizon-
tal valve position below.
Fig. 17: Pressure flow characteristics for selected pres-
sure levels of the adjustable differential pressure unit
Vertical valve position
The opening pressure of the proGAV 2.0 in the
vertical position is the sum of the opening pres-
sure of the adjustable DP-unit and the gravi-
tational unit. The following diagrams show the
pressure-flow-characteristics for some pres-
sure settings in the vertical body position. The
total opening pressure refers to a reference
flow of 5 ml/h. When the flow rates reach
20 ml/h, the opening pressures are approxi-
mately 1-2 cmH O higher.
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