Precautions And Contraindications; Functional Safety And Compatibility With Diagnostic Procedures; Adverse Reactions And Interactions; Sterilisation - miethke proGAV 2.0 Gebrauchsanweisung

GB | INSTRUCTIONS FOR USE
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 computed
tomography examinations can be performed
without risk or impairment to the valve func-
tion. The valve is MR Conditional. Supplied
catheters are MR Safe. Reservoirs, deflectors
and connectors are MR Conditional.
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.
24
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 expiry date
is printed on the wrapping of each individual
O during
2
product. If the packaging is damaged, the
product must not be used in any circum-
stances. No guarantee can be given for the
functional safety and reliability of resterilised
products.
REQUIREMENTS OF THE
MEDICAL DEVICE DIRECTIVE
(DIRECTIVE 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 implant should therefore
be recorded in the patient's medical records
and patient passport to ensure complete
traceability. Translations of these instructions
for use into additional languages can be found
on our website (https://www.miethke.com/
products/downloads).
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.
proGAV 2.0