Contraindications; Interaction With Products From Other Manufacturers; Re-Implantation; Safety Measures - MIETHKE proGAV 2.0 Instrucciones De Manejo

| INSTrUcTIONS fOr USe
GB
60
55
50
45
Adj. DP-unit 20 cmH2O
40
35
Adj. DP-unit 10 cmH2O
30
25
Adj. DP-unit 0 cmH2O
20
15
10
Gravitational unit 20 cmH
5
0 5 10 15 20 25
Flow (ml/h)
60
55
50
Adj. DP-unit 20 cmH2O
45
40
35 Adj. DP-unit 10 cmH
30
Adj. DP-unit 0 cmH
25
20
15
10
5
Gravitational unit 25 cmH
0 5 10 15 20 25
Flow (ml/h)
60
55
Verstellb. Diff.einheit 20 cmH
50
45
Verstellb. Diff.einheit 10 cmH
40
35
Verstellb. Diff.einheit 0 cmH
30
25
20
15
10
Gravitational unit 30 cmH
5
0 5 10 15 20 25
Flow (ml/h)
60
Adj. DP-unit 20 cmH
55
50
Adj. DP-unit 10 cmH
45
40
Adj. DP-unit 0 cmH
35
30
25
20
15
10
5
Gravitational unit 35 cmH
0 5 10 15 20 25
Flow (ml/h)
28
O
2
30 35 40 45 50 55
O
2
O
2
O
2
30 35 40 45 50 55
O
2
O
2
O
2
O
2
30 35 40 45 50 55
O
2
O
2
O
2
O
2
30 35 40 45 50 55
The total opening pressure refers to a reference flow of 5 ml/h.
when the flowrates reach 20 ml/h, the opening pressures are ap-
proximately 1-2 cmh O higher.
2

contraIndIcatIons

The adjustable dP-unit should not be implanted within an area
which makes locating and sensing the valve more difficult (e. g.
under a scar). The valve should lie on the periost or the bone to
make an adjustment after implantation possible.
InteractIons wIth Products from other
manufacturers
The proGAV 2.0 with gravitational unit should not be used under
any circumstances in conjunction with any additional hydrostatic
valves, as this can bring about abnormally high ventricular pressure
outside of the normal physiological range. hydrostatic valves allow
for changes in hydrostatic pressure in the drainage system caused
by changes in position. If in doubt, please contact the medical pro-
duct consultants at christoph miethke Gmbh & cO. kG.

re-ImPlantatIon

Under no circumstances should products that have had previously
been implanted in a patient be subsequently reimplanted in ano-
ther, because a successfull decontamination of the device cannot
be reached without functional degradation.

safety measures

The patients must be carefully monitored after the implantation.
reddened skin and tension in the area of the drainage tissue could
indicate infections at the shunt system. Symptoms such as head-
ache, dizzy spells, mental confusion or vomiting are common oc-
currences in cases of shunt dysfunction. Such symptoms, as well
as shunt system leakage, necessitate the immediate replacement
of the shunt component responsible, or of the entire shunt system.

comPatIbIlIty wIth dIagnostIc Procedures

mrI examinations with field strengths of up to 3.0 tesla and cT
examinations can be carried without endangering or impairing
the functionality of the shunt. The proGAV 2.0 is mr conditional
(ASTm-f2503-13). The proGAV 2.0 will not change when sub-
jected to an mrI of 1.5T or 3.0T. All components are visible via
X-ray. The provided catheters are mrI Safe. reservoirs, deflectors
and connectors are mr conditional.
Warning note: When using a magnetic field and simultaneous
pressing on the valve an adjustment of the valve cannot be
excluded. The proGAV 2.0 will produce artifacts or signal-
intensity voids in MR images larger than the physical size of
the device.

PostoPeratIve valve test

The proGAV 2.0 has been designed as a safe and reliable unit
even without the provision of a pumping device. however, there
are ways of testing the unit if a shunt system with a prechamber
or a borehole reservoir is used. Valve tests can be carried out by
flushing or pressure measurements.