General Warning - Medtronic SYNCHROMED EL serie Gebrauchsanweisung

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General Warning

The Medtronic ®
part of the Medtronic
designed to contain and administer drugs to a specific site in the
treatment of chronic diseases. The system also includes
implantable catheters and a catheter access system. The pump,
catheters, and catheter access system are implanted in the
extremely hostile environment of the human body. This
environment places severe demands on their design and function.
The pump includes a nonseparable power source which will
ultimately cease to function due to exhaustion or premature
failure thereby necessitating removal of the pump. Reasons for
failure of the pump, catheter or catheter access system include
but are not limited to: body rejection phenomena; change in
performance characteristics due to component changes or
failures; unusual physiological variations in patients; medical
complications; battery depletion; complete or partial catheter
occlusion; catheter dislodgement; catheter leakage; catheter
breakage; migration; erosion of the pump; or catheter access
system failure. In addition, despite the exercise of all due care in
design, component selection, manufacture and testing prior to
sale, the pump, catheters, and catheter access system may be
damaged before, during or after implantation by improper
handling or filling; drugs or uses not described in this technical
manual; or other intervening acts. Consequently, no
representation or warranty is made that failure or cessation of
function of the pump, catheters, or catheter access system will not
occur, or that the body will not react adversely to their
implantation. No representation is made that any one pump will
last the entire lifetime of any user. Inherent uncertainties
regarding the longevity of the power supply and other
components make any such assurance impossible.
Medtronic - Kerkrade / PARTNUMBER :
GENERAL WARNING
7 7
SynchroMed ® EL Programmable Pump (pump) is
® SynchroMed ® EL Infusion System,
198076-036 SHEETNR. :