Medical Products Consultant; Note On The Instructions For Use; Requirements Of The Mdd 93/42/Eec; General Information - MIETHKE paediGAV Mode D'emploi

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| INSTRUCTIONS FOR USE
GB
paediGAV 4/19 cmH
O
2
40
35
30
25
Pressure rating 19 cmH
O
20
2
15
10
5
Pressure rating 4 cmH
O
2
0
5
10
15
20
25
30
35
40
45
50
Flow (ml/h)
paediGAV 4/24 cmH
O
2
40
35
30
25
Pressure rating 24 cmH
O
2
20
15
10
5
Pressure rating 4 cmH
O
2
0
5
10
15
20
25
30
35
40
45
50
Flow (ml/h)
paediGAV 9/19 cmH
O
2
40
35
30
25
Pressure rating 19 cmH
O
20
2
15
10
Pressure rating 9 cmH
O
2
5
0
5
10
15
20
25
30
35
40
45
50
55
Flow (ml/h)
20
paediGAV 9/24 cmH
O
2
40
35
30
Pressure rating 24 cmH
O
2
25
20
15
10
Pressure rating 9 cmH
O
2
5
0
5
10
15
20
25
30
35
40
55
Flow (ml/h)
paediGAV 9/29 cmH
paediGAV 9/29 cmH
O
O
2
2
40
35
Pressure rating 29 cmH
Pressure rating 29 cmH
O
O
30
2
2
25
20
15
10
Pressure rating 9 cmH
Pressure rating 9 cmH
O
O
2
2
5
0
5
10
15
20
25
30
35
40
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 approximately 1-2 cmH
O higher.
2
paediGAV
paediGAV

MEDICAL PRODUCTS CONSULTANT

In compliance with the requirements of the Eu-
ropean law MDD 93/42/EEC, Christoph Miet-
hke GmbH&Co. KG names medical pro duct
consultants as the individuals to be addressed
with all queries concerning the products:
Dipl.-Ing. Christoph Miethke
Dipl.-Ing. Roland Schulz
Michaela Funk-Neubarth
Dipl.-Ing. Thoralf Knitter
45
50
55
Dr. Andreas Bunge
Jan Mügel
Contact details can be found on the reverse of
these instructions for use.

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-
45
50
55
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.
INSTRUCTIONS FOR USE |

GENERAL INFORMATION

Manufacturer
Christoph Miethke
GmbH & Co. KG
Product name
paediGAV
Intended use
Treatment of
Hydrocephalus
Intended for one-time use (disposable)
Store in a clean, dry place
Schematic representation of the valve with its external
dimensions:
4 mm
24 mm
GB
21

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