Functional Safety And Compatibility With Diagnostic Procedures; Adverse Reactions And Interactions; Sterilisation; Requirements Of The Mdd (Directive 93/42/Eec) - MIETHKE M.blue Instrucciones De Manejo

FUNCTIONAL SAFETY AND
COMPATIBILITY WITH DIAGNOSTIC
PROCEDURES
These medical devices are constructed in
such a way as to ensure their precise and reli-
able operation over long periods of time. How-
ever, no guarantee can be given that these
medical devices may not require replacement
for medical or technical reasons. These med-
ical devices are able to resist positive and
negative pressures up to 200 cmH
ing and after implantation. These medical
devices have to be stored in a clean and dry
environment at all times. Nuclear magnetic
resonance (MRI) examinations up to a field
strength of 3 Tesla or computed tomography
(CT) examinations can be performed with-
out 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.
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) may put
the integrity of the shunt system at risk.

STERILISATION

The products are sterilised with steam under
strictly controlled conditions. The expiry date
is printed on the wrapping of each individ-
ual product. If the packaging is damaged,
the product must not be used in any circum-
stances. No guarantee can be given for the
functional safety and reliability of resterilised
products.
REQUIREMENTS OF THE MDD
O dur-
2
(DIRECTIVE 93/42/EEC)
The Medical Device Directive requires com-
prehensive documentation of the where-
abouts of medical devices used in humans,
especially for implants. The individual iden-
tification number of the implanted valve
should therefore be recorded in the patient's
medical records and patient passport to
ensure complete traceability. Translations
of these instructions for use into addi-
tional languages can be found on our web-
site (https://www.miethke.com/en/products/
downloads).

MEDICAL DEVICES CONSULTANTS

In compliance
on medical devices (directive 93/42/EEC),
Christoph Miethke GmbH & Co. KG has nom-
inated medical products consultants as con-
tacts for all product-related questions.
You
consultants at:
Phone +49 331 62083-0
info@miethke.com
INSTRUCTIONS FOR USE | GB
with European
can reach our
directive
medical devices
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