Functional Safety And Compatibility With Diagnostic Procedures; Adverse Reactions And Interactions; Sterilisation; Requirements Of The Mdd (Directive 93/42/Eec) - MIETHKE proGAV 2.0 Mode D'emploi

proGAV ® 2.0
tis, peritonitis, bacteriaemia, septicaemia) in the
region a ected by the implantation.
FUNCTIONAL SAFETY AND
COMPATIBILITY WITH
DIAGNOSTIC PROCEDURES
These medical devices are constructed in such
a way as to ensure their precise and reli-
able operation over long periods of time. How-
ever, we cannot guarantee that these medical
devices will require replacement for medical or
technical reasons. These medical devices are
able to resist positive and negative pressures
up to 200 cmH O during and after implantation.
These medical devices have to be stored in a
clean and dry environment at all times.
Nuclear magnetic resonance examinations up
to a field strength of 3 Tesla or computed
tomography examinations can be performed
without risk or impairment to the valve function.
The valve is MR Conditional. Supplied catheters
are MR Safe. Reservoirs, deflectors and con-
nectors are MR Conditional.
The conditions for MR compatibility of the prod-
ucts can be found on our website:
https://www.miethke.com/downloads/
WARNING
If a magnetic field is being applied and pres-
sure is applied to the valve at the same time,
it is not possible to rule out valve adjust-
ment. In MRI the proGAV 2.0 creates arte-
facts which are larger than the valve itself.
WARNING
For people using cardiac pacemakers: it is
possible that the function of the heart pace-
maker is influenced by the implementation
of a proGAV 2.0.
ADVERSE REACTIONS
AND INTERACTIONS
In the treatment of hydrocephalus with shunts,
the following complications may arise (as
described in the literature): infections, block-
ages caused by protein and/or blood in the
cerebrospinal fluid, over/under drainage or in
very rare cases noise development. Violent
shocks from the outside (accident, fall) may put
the integrity of the shunt system at risk.
The proGAV 2.0 must not be used in conjunc-
tion with hydrostatic valves as this may result
INSTRUCTIONS FOR USE | EN
in increased ventricular pressure outside of the
physiological range. In case of doubt, please
contact the medical products consultants at
Christoph Miethke GmbH & Co. KG.

STERILISATION

The products are sterilised with steam under
strictly controlled conditions. The expiry date is
printed on the wrapping of each individual prod-
uct. If the packaging is damaged, the product
must not be used in any circumstances. No
guarantee can be given for the functional safety
and reliability of resterilised products.
REQUIREMENTS OF THE MDD (DIREC-
TIVE 93/42/EEC)
The Medical Device Directive requires com-
prehensive documentation of the fate of med-
ical devices used in humans, especially for
implants. The individual implant identification
number should therefore be recorded in the
patient's medical records and patient card to
ensure complete traceability. Translations of
these instructions for use into additional lan-
guages can be found on our website:
https://www.miethke.com/downloads/

MEDICAL DEVICES CONSULTANTS

In compliance with the European Directive con-
cerning medical devices (Directive 93/42/EEC),
Christoph Miethke GmbH & Co. KG has nomi-
nated medical devices consultants as contacts
for all product-related questions.
You can contact our medical devices consul-
tants via:
Tel. +49 331 62083-0
info@miethke.com

VARIATIONS

Fig. 18: proGAV 2.0 with SA 2.0 (VP-drainage)
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