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INSTRUCTIONS FOR USE
GB
PRESSURE-FLOW CHARACTERISTICS
The diagrams below show the pressure-flow
characteristics for the pressure ratings in which
the
miniNAV
is available.
5
10
10
20
30
40
0
5
25
15
35
45 50 55
15
20
miniNAV 0 cmH
2
O
Pressure ( cmH
2O)
Flow (ml/h)
Pressure rating 0 cmH
2
O
5
10
10
20
30
40
0
5
25
15
35
45 50 55
15
20
miniNAV 5 cmH
2
O
Pressure ( cmH
2O)
Flow (ml/h)
Pressure rating 5 cmH
2
O
5
10
10
20
30
40
0
5
25
15
35
45 50 55
15
20
miniNAV 15 cmH
2
O
Pressure ( cmH
2O)
Flow (ml/h)
Pressure rating 15 cmH
2
O
5
10
10
20
30
40
0
5
25
15
35
45 50 55
15
20
miniNAV 10 cmH
2
O
Pressure ( cmH
2O)
Flow (ml/h)
Pressure rating 10 cmH
2
O
The total opening pressure refers to a reference flow of
5 ml/h. When the flowrates reach 20 ml/h, the opening
pressures are approximately 1-2 cmH
2
O higher.
FUNCTIONAL SAFETY
The valves have been designed for long-term
reliable and precise operation. Still, the possi-
bility that the shunt system will need to be re-
placed for technical or medical reasons cannot
be excluded.
The valve and the valve system are able to re-
sist positive and negative pressure up to 200
cmH
2
O during and after implantation.
NOTE ON THE INSTRUCTIONS FOR USE
The descriptions and explanations given in this
document are based on the clinical experience
available to date. It is for the surgeon to deci-
de if surgical procedures should be changed
according to his or her experience and to sur-
gical practice.
REQUIREMENTS OF THE MDD 93/42/EEC
The MDD calls for the comprehensive docu-
mentation of the whereabouts of medical pro-
ducts that are applied in human beings, es-
pecially the whereabouts of implants. For this
reason, the individual identification numbers
of any implanted valves are to be noted in pa-
tients‘ records, so that in the event of any in-
quiries, the implant can be traced without any
difficulties. Each valve is outfitted with a sticker
for this purpose.
