Implantation; Precautions And Contraindications - MIETHKE M.scio Mode D'emploi

GB | INSTRUCTIONS FOR USE
After implantation, the variants "dome" pro-
vide the additional option, when the patient is
in a stable position, of applying gentle pres-
sure to the silicone membrane of this implant
to observe a pressure change in the measure-
ment curves.
The measuring cell is calibrated. Its correct
functioning is guaranteed under the following
conditions:
Temperature range
Pressure measuring
range (relative)
Pressure measuring
range (absolute)
CAUTION
Excessive pumping of the variant "dome"
can result in excessive drainage and thus
lead to pressure conditions outside the nor-
mal physiological range. The patient should
be properly informed about this risk.
CAUTION
Conclusion about absolute pressure: in
patients with acute or chronic brain disor-
ders or injuries (e.g. craniocerebral trauma,
cerebral haemorrhage, hydrocephalus, brain
tumours, etc.), please note that the measur-
ing cell can only be used to obtain differen-
tial intracranial pressure measurements (rel-
ative, time-dependent pressure changes in
CSF) when taking cerebral pressure read-
ings. The readings taken by the measuring
cell do not permit conclusions as to the
absolute pressure within the cranial cavity.
To determine such absolute pressure val-
ues, reference pressure has to be assessed
transcutaneously.
NOTE
Increased temperature: if the patient has a
raised temperature, functional impairment of
the Reader Unit Set may occur (see instruc-
tions for use for the Reader Unit Set). In read-
out mode, the temperature in the M.scio may
rise. An integrated temperature safety device
stops the measurement at 39 °C as well as
in the event of temperature increases by 2
Kelvin in the implant.
10
20°C ... 39°C
-66.66 hPa ...
+133.32 hPa
(-50 mmHg ...
+100 mmHg)
800 hPa ...
1100 hPa
NOTE
Metal parts: the telemetric link between the
antenna of the Reader Unit Set and the implant
may be disrupted by metal components
within the vicinity of the implant. In this case,
increase the distance to the metal parts.

IMPLANTATION

The M.scio must always be placed outside
of the skullcap. A burrhole with a diameter
of 10 mm is recommended for the implanta-
tion of the "angled" variants. The M.scio is
designed for use with catheters with an inner
diameter of approx. 1.2 mm and an outer
diameter of approx. 2.5 mm. The ventricu-
lar catheter is implanted with the help of a
mandrel. The implantation of the "inline" vari-
ants also requires a burrhole deflector to ori-
ent the ventricular catheter at a 90° angle.
The M.scio is connected to the shunt system.
The individual connections must be secured
by a ligature. We recommend using Miethke
products in combination with the M.scio. The
position of the ventricular catheter should be
checked after the procedure by CT or MRI. It is
recommended to check the entire shunt sys-
tem for patency.
CAUTION
Products that
implanted must not subsequently be reim-
planted into the same or another patient.
PRECAUTIONS AND
CONTRAINDICATIONS
Patients must be carefully monitored after
implantation. Reddening of skin or tightness
in the area of the implant may be indications
of infections at the shunt system. Symptoms
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.
M.scio
have previously been