Re-Sterilization; Contraindication; Accessories; Requirements Of The Medical Device Directive Rl 93/42/Eec - miethke THOMALE GUIDE Gebrauchsanweisung

RE-STERILIZATION

The THOMALE GUIDE should be sterilized in its
sterile double wrapping in an autoclave (steam
sterilzation, fractionated vacuum method) at
134° C and 5 minutes cycling time. Demount all
parts prior to sterilization. Since different cath-
eter guides can be applied during operation,
corresponding to the used ventricular catheter,
we recommend to pack each catheter guide in
a separate sterile bag and to mark them ac-
cordingly.

CONTRAINDICATION

The usage of the THOMALE GUIDE is advised
against if a frontal way to the ventricles is not
possible or not indicated, a parietal or occipital
entry to the ventricle is not possible, a irregu-
lar anatomy of the skull surface or a FOHWR
smaller than 0,05 exist.
Explanation: At a smaller FOHWR-value parti-
cularly close slit ventricles exist. In this case use
a navigation guide for the positioning of the VC.

ACCESSORIES

The THOMALE GUIDE Application was de-
signed as an accessory for the THOMALE
GUIDE.
It serves for determination and calculation of
the insertion angle, of the catheter length and
of the position of the burrhole when puncturing
the pre-coronary ventricle with a VC.
REQUIREMENTS OF THE MEDICAL DE-
VICE DIRECTIVE RL 93/42/EEC
The MDD calls for the comprehensive docu-
mentation of the wherabouts of medical pro-
ducts that are applied on human beings. The
requirements on product identification and
traceability has to be maintained also at the
user's area.
NOTE ON THE INSTRUCTIONS FOR USE
The descriptions and explanations given in this
document are based on the clinical experience
available up to date. It is for the surgeon to de-
cide if surgical procedures should be changed
according to his or her experience and to surgi-
cal practice.

MEDICAL PRODUCT CONSULTANT

In compliance with the requirements of the
European law MDD 93/42/EEC, Christoph Mi-
ethke GmbH & Co. KG names medical product
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
D-14469 Potsdam
Tel.: +49(0) 7000 MIETHKE oder
Tel.: +49 (0) 331 62083 0
Fax: +49 (0) 331 62083 40
E-mail: info@miethke.com
Please adress any enquiries to:
AESCULAP AG
Am Aesculap Platz
D-78532 Tuttlingen
Tel.: +49 (0) 7461 95 0
Fax: +49 (0) 7461 95 26 00
E-mail: information@aesculap.de
INSTRUCTIONS FOR USE |
GB
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