Postoperative Valve Tests; Functional Safety; Adverse Reaction; Sterilisation - MIETHKE DUALSWITCH VALVE Instrucciones De Manejo

| INSTRUCTIONS FOR USE
GB
POSTOPERATIVE VALVE TEST
The DUALSWITCH VALVE was designed as a safe and reliable unit
operating without a pump or test equipment, so as to prevent un-
wanted interference by unauthorized or unqualified persons. Ho-
wever, there are ways of testing if the Prechamber or the Borehole
Reservoir is used. Apart from that, the functioning of the tantalum
ball switch can be checked by means of X-ray imaging of the valve
with the patient standing upright and lying down. The tantalum ball,
which switches between the two valve levels, appears as a near-
white circle in the X-ray picture. In the picture for the horizontal
position, a dark shadow must be visible directly below the ball, in
the direction of the fluid flow; this shade is not visible in the picture
for the upright position. A shadow being visible independent of the
patient's position (oblong bar, see fig. 8b) means that the tantalum
ball does not close when the patient stands up. In this case, the
valve operates like a conventional differential pressure valve. If no
shadow is visible, independent of the patient's position, the valve
operates in high-pressure mode even when the patient is lying
down, which means that the valve must be replaced.
a) b)
Fig. 8: DUALSWITCH VALVE in
a) vertical and b) horizontal position

FUNCTIONAL SAFETY

The valves have been designed for long-term reliable and precise
operation. Still, the possibility that the shunt system needs to be
replaced for technical or medical reasons, cannot be excluded.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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Warning note for carriers of pacemakers: Due to the implan-
tation of a DSV 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.

STERILISATION

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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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 instructions given above
are based on clinical experience available to
date. The shunt systems have been implanted
according to the instructions given in this do-
cument, in clinical trials. It is the responsibility
of the individual surgeon to change procedures
according to her/his experience and surgical
practice. He or she also does so at their own
risk. However, the valve should always be im-
planted in the thorax area (or, in case of L-P
drainage, on the arcus costalis), and not in the
region of the head.
Implantation in the thorax area ensures that
the valve switches to the appropriate pressu-
re mode when the patient changes his or her
position.

MEDICAL PRODUCTS CONSULTANT

In compliance with the requirements of the Eu-
ropean law MDD 93/42/EEC, Christoph Mieth-
ke 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
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: info@miethke.com
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: information@aesculap.de
INSTRUCTIONS FOR USE |

GENERAL INFORMATION

Manufacturer Christoph Miethke
GmbH & Co. KG
Product name DUALSWITCH VENTIL
Intended use Treatment of
Hydrocephalus
Intended for one-time use (disposable)
Store in a clean, dry place
Drawing of the valve with the outer dimension in mm:
5,3 mm
DUALSWITCH VALVE without integrated catheter
GB
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