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Idiomas disponibles
Idiomas disponibles
miniNAV
RESTERILISATION
The functional safety and reliability of resterilized
products cannot be guaranteed, therefore re-
sterilisation is not recommended.
PRESSURE-FLOW CHARACTERISTICS
The diagrams below show the pressure-flow
characteristics for the pressure ratings in which
the miniNAV is available.
miniNAV 0 cmH
O
2
20
15
10
5
Pressure rating 0 cmH
0
5
10
15
20
25
Flow (ml/h)
miniNAV 5 cmH
O
2
20
15
10
Pressure rating 5 cmH
5
0
5
10
15
20
25
Flow (ml/h)
miniNAV 10 cmH
O
2
20
15
Pressure rating 10 cmH
10
5
0
5
10
15
20
25
Flow (ml/h)
O
2
30
35
40
45
50
55
O
2
30
35
40
45
50
55
O
2
30
35
40
45
50
55
INSTRUCTIONS FOR USE |
miniNAV 15 cmH
O
2
20
Pressure rating 15 cmH
15
10
5
0
5
10
15
20
25
Flow (ml/h)
The total opening pressure refers to a refe-
rence flow of 5 ml/h. When the flowrates reach
20 ml/h, the opening pressures are approxima-
tely 1-2 cmH
O higher.
2
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
O during and after implantation.
2
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.
O
2
30
35
40
45
50
55
GB
17
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