Sterile First Delivery; Re-Use - miethke THOMALE GUIDE Gebrauchsanweisung

up to the dura. The positioning of the catheter
tip can be controlled by the lateral opening in
the base ring.
Please note that while cautiously pushing the
ventricular catheter, the catheter tip points di-
rectly to the previously created dura opening
and that the dura boarders will not be affected.
Each contact with the dura bears the risk of de-
flecting the catheter. Control the insertion depth
whilst moving the catheter in the direction of the
ventricle. Through the lateral openings of the
base ring, the markings on the VC can be iden-
tified and read. The standard insertion length in
adult patients is about 60 to 65 mm. Ideally, the
length can be determined individually by pre-
operative measurement of a coronary image.
When positioned correctly, the catheter is then
fixed at the burrhole level with the aid of atrau-
matic forceps through the lateral opening of the
base ring. Remove the stylet and check for cor-
rect CSF flow. Now the THOMALE GUIDE can
be removed from the site without changing the
position of the catheter.

STERILE FIRST DELIVERY

The THOMALE GUIDE is supplied sterile and it
is re-sterilizable.
The products are sterilized with steam under
closely monitored conditions. The double wrap-
ping 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.
Note: in any case the position of the VC
should be monitored post-operatively. The
Christoph Miethke GmbH & Co.KG assumes
no liability in case of misplacement the ven-
tricular catheter.

RE-USE

Cleaning and disinfection of the THOMALE
GUIDE
To ensure validated cleaning of the THOMALE
GUIDE it has to be disassembled into its four
components (see chapter Assembly and Com-
ponents).
Avoid damage to the product due to inappro-
priate cleaning/disinfecting agents and/or exes-
sive temperatures!
• Use cleaning and disinfecting agents ap-
proved for surgical steels according to the
manufacturer's instructions.
• Observe specifications regarding concentra-
tion, temperature and exposure time.
• Do not exceed the maximum allowable
cleaning temperature of 55°C.
• Carry out ultrasound cleaning:
- as an effective mechanical supplement to
manual cleaning/disinfecting.
- as a pre-cleaning procedure for products
with encrusted residues, in preparation
for mechanical cleaning/disinfecting.
- as an integrated mechanical support meas-
ure for mechanical cleaning/disinfecting.
- for additional cleaning for products with
residues left after mechanical cleaning/
disinfecting.
• Clean and disinfect the THOMALE GUIDE
mechanically, provided it can be securely
fixed in machines or storage devices in such
a way that the THOMALE GUIDE will be
thoroughly cleaned.
Manual cleaning/disinfecting
• Check visible surfaces for residues after
manual cleaning/disinfecting.
• Repeat the cleaning process if neccessary.
Mechanical cleaning/disinfecting
• Place the product on a tray that is suitable for
cleaning (avoid rinsing blind spots).
Control, care and inspection
• Allow the product to cool down to room tem-
perature.
• Inspect the product after each cleaning and
disinfecting cycle to be sure it is clean, func-
tioning properly, not damaged and does not
have any loose, bent, broken, cracked, worn,
or fractured components.
INSTRUCTIONS FOR USE |
GB
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