Re-Implantation; Safety Measures; Compatibility With Diagnostic Procedures; Postoperative Valve Test - miethke GAV Gebrauchsanweisung

| INSTRUCTIONS FOR USE
GB

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 GAV is MR Conditional (ASTM
F2503-13). All components are visible via X-ray. The provided ca-
theters are MRI Safe. Reservoirs, deflectors and connectors are
MR Conditional.

POSTOPERATIVE VALVE TEST

The GAV has been designed as a safe and reliable unit even wit-
hout the provision of a pumping device. However, there are ways
of testing the unit if a shunt system with a prechamber or a bore-
hole reservoir is used. Valve tests can be carried out by flushing or
pressure measurements.

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.
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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.

RESTERILISATION

The functional safety and reliability of resterilized products cannot
be guaranteed, therefore resterilisation is not recommended.
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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
Christoph Miethke GmbH & Co. KG
Ulanenweg 2
14469 Potsdam · Germany
Phone: +49 331 620 83 0
Fax: +49 331 620 83 40
e-mail: info@miethke.com
Please address any enquiries to:
AESCULAP AG
Am Aesculap-Platz
78532 Tuttlingen · Germany
Phone: +49 7461 95 0
Fax: +49 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
GAV