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Testing The Valve Patency; Pressure-Flow-Characteristics; Re-Implantations; Safety Measures - MIETHKE DUALSWITCH VALVE Instrucciones De Manejo

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| INSTRUCTIONS FOR USE
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TESTING THE VALVE PATENCY

The DSV can be filled most gently by aspiration through a sterile,
single-use syringe attached to the distal end of the catheter. The
proximal end of the valve is immersed in a sterile, physiological
saline solution. The valve is patent if fluid can be extracted in this
way (see fig. 7).
isotonic sterile sodium chloride solution
Fig. 7: Patency test
Caution: Pressure admission through the single-use syringe
should be avoided, both at the proximal and the distal end.
Contaminations in the solution used for the test can impair the
product's performance.
PRESSURE-FLOW CHARACTERISTICS
The diagrams below show the pressure-flow characteristics for the
pressure ratings in which the DUALSWITCH VALVE is available.
DSV 5/30 cmH
O
2
60
55
50
45
40
35
30
25
Pressure rating 30 cmH
O
2
20
15
Pressure rating 5 cmH
O
2
10
5
0
5
10
15
20
25
30
35
40
45 50 55
Flow (ml/h)
DSV 10/30 cmH
O
2
60
55
50
45
40
35
30
25
Pressure rating 30 cmH
O
2
20
15
10
Pressure rating 10 cmH
O
2
5
0
5
10
15
20
25
30
35
40
45 50 55
Flow (ml/h)
22
DSV 13/30 cmH
O
2
60
55
50
45
40
35
30
25
Pressure rating 30 cmH 2 O
20
15
10
Pressure rating 13 cmH 2 O
5
0
5
10
15
20
25
30
35
40
45 50 55
Flow (ml/h)
DSV 16/30 cmH
O
2
60
55
50
45
40
35
30
25
Pressure rating 30 cmH
O
2
20
15
Pressure rating 16 cmH
O
2
10
5
0
5
10
15
20
25
30
35
40
45 50 55
Flow (ml/h)
DSV 5/40 cmH
O
2
60
55
50
45
40
35
Pressure rating 40 cmH
O
2
30
25
20
15
Pressure rating 5 cmH
O
2
10
5
0
5
10
15
20
25
30
35
40
45 50 55
Flow (ml/h)
DSV 10/40 cmH
O
2
60
55
50
45
40
35
Pressure rating 40 cmH
O
2
30
25
20
15
10
Pressure rating 10 cmH
O
5
2
0
5
10
15
20
25
30
35
40
45 50 55
Flow (ml/h)
DSV 13/40 cmH
O
2
60
55
50
45
40
35
Pressure rating 40 cmH
O
2
30
25
20
15
10
Pressure rating 13 cmH
O
2
5
0
5
10
15
20
25
30
35
40
45 50 55
Flow (ml/h)
DSV 16/40 cmH
O
2
60
55
50
45
40
35
Pressure rating 40 cmH
O
2
30
25
20
15
Pressure rating 16 cmH
O
2
10
5
0
5
10
15
20
25
30
35
40
45 50 55
Flow (ml/h)
DSV 5/50 cmH
O
2
60
55
50
45
Pressure rating 40 cmH
O
2
40
35
30
25
20
15
Pressure rating 5 cmH
O
2
10
5
0
5
10
15
20
25
30
35
40
45 50 55
Flow (ml/h)
DSV 10/50 cmH
O
2
60
55
50
45
Pressure rating 40 cmH
O
2
40
35
30
25
20
15
10
Pressure rating 5 cmH
O
5
2
0
5
10
15
20
25
30
35
40
45 50 55
Flow (ml/h)
INSTRUCTIONS FOR USE |
DSV 13/50 cmH
O
2
60
55
50
45
Pressure rating 40 cmH
O
2
40
35
30
25
20
15
10
Pressure rating 5 cmH
O
2
5
0
5
10
15
20
25
30
35
40
45 50 55
Flow (ml/h)
DSV 16/50 cmH
O
2
60
55
50
45
Pressure rating 40 cmH
O
2
40
35
30
25
20
15
Pressure rating 5 cmH
O
2
10
5
0
5
10
15
20
25
30
35
40
45 50 55
Flow (ml/h)
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 cmH2O higher.
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 hea-
dache, 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 DSV is MR conditional (ASTM-F2503-13). 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 pres-
sing on the valve an adjustment of the valve cannot be excluded.
GB
23

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