Idiomas disponibles
Idiomas disponibles
| InstructIons for use
GB
reImplantatIon
Under no circumstances should products that
have had previously been implanted in a pati-
ent be subsequently reimplanted in another,
because a successfull decontamination of the
device cannot be reached without functional
degradation.
compatIBIlIty WIth dIagnostIc
procedures
Like other shunt components of the Christoph
Miethke GmbH & Co. KG (when applied), the
prechamber and the CONTROL RESERVOIR
consist of the nonmagnetic substances titani-
um, sapphire and silicone. Consequently, the
reservoirs and catheters will not interfere with
either nuclear magnetic resonance (MRI) or
computer tomographic (CT) procedures. The
prechamber and the CONTROL RESERVOIR
are MR Conditional (ASTM-F2503-08). The
provided catheters are MRI Safe. All compon-
ents are visible via X-ray.
safety measures
Following implantation of a shunt system, the
patient´s condition should be carefully and tho-
roughly monitored. Inflammation and tension
around the drainage tissues could possibly be
a sign of infection in the shunt system.
Symptoms such as headache, dizziness, dis-
orientation or vomiting often occur in cases of
shunt dysfunction.
In the event such symptoms occur or if there is
any leakage in the shunt system, either the in-
dividual shunt system components or the entire
shunt system must be replaced without delay.
sterIlIzatIon
All products are carefully and thoroughly steri-
lised. Owing to the fact that the products are
packaged in two layers of sterile packaging,
five years of sterility are guaranteed. The ex-
piration date for each item is indicated on the
package. If the packaging is damaged in any
way, the product should not be used under any
circumstances.
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resterIlIzatIon
The functional safety and reliability of re-
sterilised products cannot be guaranteed.
functIonal safety
The valves have been designed for long-term
reliable and precise operation. Still, the possibi-
lity that the shunt system needs to be replaced
for technical or medical reasons, cannot be ex-
cluded.The valve and the valve system are able
to resist positive and negative pressure up to
200 cmH
O during and after implantation.
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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.
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.
medIcal products consultant
In
compliance
with
the
requirements
of the European law MDD 93/42/EEC,
Christoph Miethke GmbH&Co. KG names me-
dical pro duct consultants as the individuals to
be addressed with all queries concerning the
products:
Dipl.-Ing. Christoph Miethke
Dipl.-Ing. Roland Schulz
Christoph Miethke GmbH & Co. KG
Ulanenweg 2
14469 Potsdam · Germany
Phone:
+49(0) 7000 MIETHKE or
Phone:
+49(0) 331 620 83 0
Fax:
+49(0) 331 620 83 40
e-mail: [email protected]
Please address any enquiries to:
AESCULAP AG
Am Aesculap-Platz
78532 Tuttlingen · Germany
Phone:
+49 (0) 7461 95 0
Fax:
+49 (0) 7461 95 26 00
e-mail: [email protected]
Service address in the US
AESCULAP Inc.
Attn. AESCULAP Technical Services
615 Lambert Pointe Road
Hazelwood, MO, 63042
AESCULAP Repair Hotline
Phone:
+1 (800) 214-3392
Fax:
+1 (314) 895-4420
Distributor in the US/ Contact in Canada
AESCULAP Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Phone:
+1-800-282-9000
www.aesculapusa.com
InstructIons for use |
general InformatIon
Manufacturer
Christoph Miethke
GmbH & Co. KG
Product name
see variations
Intended use
Treatment of
hydrocephalus
Intended for one-time use (disposable)
Store in a clean, dry place
Schematic representation of the prechamber with its
external dimensions:
standard:
Height 5,65 mm
pediatric:
Height 4,75 mm
GB
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