Precautionary Measures And Contraindications; Functional Safety And Compatibility With Diagnostic Procedures; Adverse Reactions And Interactions - MIETHKE M.blue Mode D'emploi

EN | INSTRUCTIONS FOR USE
Fig. 22: Pressure in (cmH
Pressure-flow characteristics of selected pressure lev-
els of M.blue in the vertical body position:
The opening pressure refers to a reference flow
of 20 ml/h.
PRECAUTIONARY MEASURES 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, ventriculi-
tis, peritonitis, bacteriaemia, septicaemia) in the
region affected by the implantation.
28
O); flow rate in (ml/h)
2
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 med-
ical devices may not require replacement for
medical or technical reasons. These medical
devices 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 (MRI) examina-
tions up to a field strength of 3 Tesla or com-
puted tomography (CT) examinations can be
performed without risk or impairment to the
valve function. The valve is MR Conditional. The
supplied catheters are MR Safe. Reservoirs,
deflectors and connectors are MR Conditional.
The conditions for MR compatibility of the
products 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,
thus triggering the brake mechanism, it is not
possible to rule out valve adjustment. In MRI
imaging M.blue creates artefacts which are
larger than the valve itself.
CAUTION
For people using cardiac pacemakers: It is
possible that the function of the pacemaker
is influenced by the implantation of a M.blue.
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-/underdrainage or in
very rare cases noise development. Violent
shocks for the outside (accident, fall etc.) may
put the integrity of the shunt system at risk.
M.blue
®
O during and after
2