Functional Safety; Adverse Reaction; Sterilization; Resterilization - MIETHKE proGAV 2.0 Instrucciones De Manejo

functIonal safety

The valves have been designed for long-term reliable and precise
operation. Still, it cannot be excluded that the shunt system needs
to be replaced for technical or medical reasons. The valve and the
valve system are able to resist positive and negative pressure up to
200 cmh O during and after implantation.
2
Warning note for carriers of pacemakers:Due to the implan-
tation of a proGAV 2.0 the function of a pacemaker can be
affected.

adverse reactIon

In the treatment of hydrocephalus with shunts, the following com-
plications may arise (as described in the literature): infections, blo-
ckages caused by protein and/or blood in the cerebrospinal fluid,
over/under drainage or in very rare cases, noise development.
due to violent shocks from the outside (accident, fall, etc.) the inte-
grity of the shunt may be endangered.

sterIlIzatIon

The products are sterilized with steam under closely monitored
conditions. The double wrapping in sterile bags ensures sterility for
a period of five years. The expiry date is printed on the wrapping of
each individual product. Products taken from a damaged wrapping
must not be used under any circumstances.

resterIlIzatIon

The functional safety and reliability of resterilized products cannot
be guaranteed, therefore resterilisation is not recommended.

note on the InstructIons for use

The descriptions and explanations given in this document are ba-
sed on the clinical experience available to date. It is for the surgeon
to decide if surgical procedures should be changed according to
his or her experience and to surgical practice.

requIrements of the mdd 93/42/eec

The mdd calls for the comprehensive documentation of the
whereabouts of medical products that are applied in human
beings, especially the whereabouts of implants. for this reason,
the individual identification numbers of any implanted valves are to
be noted in patients' records, so that in the event of any inquiries,
the implant can be traced without any difficulties. each valve is
outfitted with a sticker for this purpose.
INSTrUcTIONS fOr USe |
MEDICAL PRODuCTS COnSuLTAnT
In compliance with the requirements of the eu-
ropean law mdd 93/42/eec, christoph miethke
Gmbh & co. kG names medical pro duct con-
sultants 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
d-14469 Potsdam · Germany
Phone: +49(0) 7000 6438453 or
Phone: +49(0) 331 620 83 0
fax: +49(0) 331 620 83 40
e-mail: info@miethke.com
Please address any enquiries to:
AeScUlAP AG
Am Aesculap Platz
d-78532 Tuttlingen · Germany
Phone: +49 (0) 7461 95-0
fax: +49 (0) 7461 95-26 00
e-mail: information@aesculap.de
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
GB
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