Mode Of Operation; Functional Test - MIETHKE M.scio Mode D'emploi

M.scio

MODE OF OPERATION

The Reader Unit Set is used to read and
display the measured data of the measuring
cell in the M.scio. The measured data may
only be read out using the Reader Unit Set
(FV905X / FV907X). Measured data are auto-
matically stored on the associated SD card for
later evaluation. The relative behaviour of the
CSF pressure in the shunt system can provide
information about its function. This permits the
non-invasive detection, localisation and eval-
uation of an occlusion within the shunt system
as well as a mechanical loss of function.
CAUTION
Looking at these relative pressure readings
in isolation can not be taken as reliable data
for absolute brain pressure. Even though the
pressure measurement in the Reader Unit Set
is monitored regularly, thus complying with
all criteria of a calibrated assessment, the
same is not possible for the implanted cell.
If the shunt system is to be revised on
the basis of data gained from the implant
with integrated measuring cell, the diagnosis
must be confirmed through combination with
other non-invasive, but also interventional and
radiological diagnostic methods (CT, MRI, tap
or another method).
Fig. 2: Pressure measurement with the M.scio and
Reader Unit Set
INSTRUCTIONS FOR USE | GB

FUNCTIONAL TEST

Functional tests prior to implantation
NOTE
The functionality of the implant must be
tested prior to implantation.
The Reader Unit Set and the SD card associ-
ated with the implant are used to test whether
the measuring cell can be addressed correctly
(see instructions for use for the Reader Unit
Set). If the sensor ID (individual measuring
cell number) is recognised by the Reader Unit
Set, measured data can be read correctly. The
M.scio should be checked for patency prior to
implantation. Permeability can be checked by
aspiration of a sterile fluid from the distal end
and this also allows air to be removed from
the implant.
Post-implantation functional test
After implantation, the functionality of the
implant should be checked once again with
the aid of the Reader Unit Set and the asso-
ciated SD card (see instructions for use for
the Reader Unit Set). Once communication is
established between the measuring cell and
the Reader Unit Set and the implant is correctly
integrated into the shunt system, a plausibil-
ity test can be performed. The "fast measure-
ment" mode is usually used to observe pulses
(pulse waves) and ventilatory fluctuations in
the pressure signal.
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