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

proGAV 2.0
PRECAUTIONS AND
CONTRAINDICATIONS
Patients must be carefully monitored after im-
plantation. Reddening of skin or tightness in the
area of the drained tissue may be indications of
infections at the shunt system. Symptoms such
as headache, dizziness, confusion or vomiting
often occur in conjunction with shunt dysfunc-
tion. These symptoms and a leakage within the
shunt system require the immediate replace-
ment of the affected shunt component or the
entire shunt system.
The implantation of medical devices is contra-
indicated if the patient has an infection or su-
spected infection (e.g. meningitis, ventriculitis,
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 reliable
operation over long periods of time. However,
no guarantee can be given that these medical
devices may not require replacement for me-
dical or technical reasons. These medical de-
vices are able to resist positive and negative
pressures up to 200 cmH
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 tomo-
graphy 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 connec-
tors are MR Conditional.
Warning notice: If a magnetic field is being
applied and pressure 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.
Warning notice for people using cardiac
pacemakers: it is possible that the function
O during and after
2
INSTRUCTIONS FOR USE |
of the heart pacemaker 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 de-
scribed in the literature): infections, blockages
caused by protein and/or blood in the cerebro-
spinal 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
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 double wrap-
ping in sterile bags ensures sterility for a five-
year period. The expiry date is printed on the
wrapping of each individual product. If the pa-
ckaging 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 93/42/EEC

The Medical Device Directive requires the com-
prehensive documentation of the whereabouts
of medical devices used in humans. The indivi-
dual identification number of the implanted val-
ve should therefore be recorded in the patient's
medical records and patient data card to ensu-
re complete traceability.
Translations of these instructions for use into
additional languages can be found on our web-
site (https://www.miethke.com/en/products/
downloads/).
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