Precautions And Contraindications; Functional Safety And Compatibility With Diagnostic Procedures; Adverse Reactions And Interactions; Sterilisation - MIETHKE proGAV 2.0 Mode D'emploi

proGAV 2.0
PRECAUTIONS AND
CONTRAINDICATIONS
Patients must be carefully monitored after
implantation. Reddening of skin or tightness in
the area of the drained tissue may be indica-
tions of infections at the shunt system. Symp-
toms such as headache, dizziness, confusion
or vomiting often occur in conjunction with
shunt dysfunction. These symptoms and a
leakage within the shunt system require the
immediate replacement of the affected shunt
component or the entire shunt system.
The implantation of medical devices is con-
traindicated if the patient has an infection or
suspected infection (e.g. meningitis, ventri-
culitis, peritonitis, bacteriaemia, septicaemia)
in the region affected 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, no guarantee can be given that these
medical devices may not require replacement
for medical or technical reasons. These med-
ical devices are able to resist positive and
negative pressures up to 200 cmH
and after implantation. These medical devices
have to be stored in a clean and dry environ-
ment at all times.
Nuclear magnetic resonance examinations
up to a field strength of 3 Tesla or com-
puted tomography examinations can be per-
formed without risk or impairment to the valve
function. The valve is conditionally MR safe.
Supplied catheters are MR Safe. Reservoirs,
deflectors and connectors are conditionally
MR safe.
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 adjustment.
In MRI the proGAV 2.0 creates artefacts which
are larger than the valve itself.
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 con-
junction with hydrostatic valves as this may
result in increased ventricular pressure out-
side 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 double
wrapping in sterile bags ensures sterility for a
O during
2
five-year period. The expiry date is printed on
the wrapping of each individual product. If the
packaging is damaged, the product must not
be used in any circumstances. No guarantee
can be given for the functional safety and reli-
ability of resterilised products.

REQUIREMENTS OF THE MDD 93/42/EEC

The Medical Device Directive requires com-
prehensive documentation of the where-
abouts of medical devices used in humans,
especially for implants. The individual identifi-
cation number of the implanted valve should
therefore be recorded in the patient's med-
ical records and patient data card to ensure
complete traceability. Translations of these
instructions for use into additional languages
can be found on our website (https://www.mi-
ethke.com/en/products/downloads/).
INSTRUCTIONS FOR USE | GB
WARNING
Warning notice for people using cardiac
pacemakers: it is possible that the function
of the heart pacemaker is influenced by the
implementation of a proGAV 2.0.
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