Functional Safety; Compatibility With Diagnostic And Therapeutic Procedures; Side Effects; Sterilisation - MIETHKE M.scio Mode D'emploi

M.scio
Violent shocks for the outside (accident, fall)
may put the integrity of the shunt system and
M.scio at risk. If high pressure or physical
shocks are likely from patient activities (diving,
boxing, football, etc.), a M.scio should not be
used in shunt systems.

FUNCTIONAL SAFETY

The 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 med-
ical or technical reasons. The M.scio as well
as the entire shunt system are safely able to
resist positive and negative pressures up to
100 mmHg during and after the procedure.
These medical devices have to be stored in a
clean and dry environment at all times.
If the measuring cell fails, the variants
"dome" continue to function as a conventional
burrhole reservoir or a conventional precham-
ber without any limitations, while the "flat" vari-
ants function as a connector or deflector. The
integrated measuring cell poses no additional
risk.
COMPATIBILITY WITH DIAGNOSTIC AND
THERAPEUTIC PROCEDURES
The M.scio consists of the non-magnetic
materials PEEK and titanium, while the variant
"dome" also contains silicone. The optional
distal catheters are made of silicone. MRI or
CT scans can be performed without impair-
ment up to a field strength of 3 Tesla. Arte-
facts can occur in MRI scans. The M.scio is
MR Conditional. Supplied catheters are MR
Safe.
CAUTION
During therapeutic ultrasound procedures,
there is a risk of the concentration of
the ultrasound field being unintentionally
increased and thus injuring the patient.
NOTE
The use of energy-emitting devices such as
defibrillators and HF devices can cause the
measuring cell to fail!
INSTRUCTIONS FOR USE | GB
NOTE
In cases where an electrical current from an
external source comes into contact with the
body, the measuring cell can sustain dam-
age.
NOTE
The use of radiation therapy and radionuclide
patient imaging procedures can cause the
measuring cell to fail.

SIDE EFFECTS

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.

STERILISATION

The products are sterilised with ethylene
oxide under strictly controlled conditions. The
double wrapping in sterile bags ensures steril-
ity for a three-year period. If the packaging is
damaged, the product must not be used in any
circumstances. No guarantee can be given for
the functional safety and reliability of rester-
ilised products.

SHELF LIFE AND STORAGE

The expiry date is printed on the package.
The function of the variants "dome" as pure
burrhole reservoirs and prechambers as well
as that of the variants "flat" as connectors and
deflectors is not influenced by the measuring
cell.
Temperature range
for storage
Pressure range for
storage

PATIENT DATA CARD AND SD CARD

The treating physician is encouraged to fill in
the complete patient data card. In addition to
the patient data card, the patient is given an
SD card on which all individual data about the
implant are stored. If the SD card is lost, it can
be reordered by specifying the serial number
of the M.scio or the sensor ID.
0°C
... 50°C
800 hPa
... 1100 hPa
11