Introduction; Indications; Contraindications - Medtronic SYNCHROMED EL serie Gebrauchsanweisung

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INTRODUCTION

The implantable Medtronic
part of the SynchroMed
parenteral drugs to a specific site. The implantable components of the
SynchroMed ® EL Infusion System include the pump with or without a side
catheter access port (10 or 18 ml reservoir volume), catheters, and catheter
accessories.
A programmer, the external part of the system, is used to noninvasively
interrogate and program the implanted pump. Using telemetry, the programmer
establishes a two-way, radio-frequency link with the implanted pump via the
programming head. The programming head transmits interrogation and
programming signals to the pump and receives status information from the
pump.
Do not implant, fill, refill or access the side catheter access port of a
SynchroMed ® EL pump without ensuring a thorough familiarity with the
information contained in this technical manual. Failure to strictly adhere to
these technical instructions can result in complications from a failure of the
intended therapy to a clinically significant or fatal drug overdose.

INDICATIONS

The SynchroMed ® EL Programmable Pump is intended for chronic infusion of
drugs or fluids tested as compatible (refer to DRUG INFORMATION section).
Physicians prescribing the SynchroMed
drugs must be familiar with the drug stability information listed in Table 1,
page 11.
Physicians prescribing the SynchroMed
drugs must be familiar with the indications, contraindications, warnings, and
screening procedures described in the drug labeling.

CONTRAINDICATIONS

Implantation of this device is contraindicated in the presence of infection unless
indicated for osteomyelitis.
Implantation of this device is contraindicated when the pump cannot be
implanted 2.5 cm (1 inch) or less from the surface of the skin.
Implantation of this device is contraindicated in patients whose body size is not
sufficient to accept the pump bulk and weight.
Blood sampling through the side catheter access port (if present) is contraindicated.
The side catheter access port has not been tested for blood withdrawal. If the
presence of blood in the side catheter access port is suspected, flush with a
minimum of 10 ml of saline (a heparinized solution may be used if not
contraindicated).
Contraindications relating to the use of the prescribed drug must be observed.
Medtronic - Kerkrade / PARTNUMBER :
Introduction; Indications; Contraindications
® SynchroMed ® EL Programmable Pump (pump) is
® EL Infusion System designed to contain and administer
® EL Infusion System for use with these
® EL Infusion System for use with these
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