Preimplant; Implant - Medtronic SYNCHROMED EL serie Gebrauchsanweisung

PHM036En2.qxd 2/16/00 12:03 PM Page 3
Warnings 3
The programmer's radiofrequency (RF) head contains a strong magnet used in
programming the SynchroMed ® EL pump. The resulting magnetic field may affect
other implanted programmable medical devices. The physician must identify the
other device and assess the effects of a magnetic field on that device. Medtronic
can assume no responsibility for the magnetic field effects on other devices.

Preimplant

Carefully examine the shipping package and sterile tray containing the pump
(Sterilization method: ethylene oxide gas). If the package is damaged, the sterile
seal broken, or the "Use Before..." date is past, do not implant or resterilize the
pump. Contact your local Medtronic representative.
The pump is intended for "single use only" - DO NOT reuse.
During presurgical discussions, give the patient complete information concerning
adverse events, emergency procedures, system complications or system failure,
alarms, initial fill, refill and side catheter access port procedures, refill schedules,
the consequences of "Twiddler's Syndrome" (manipulation of the pump through
the skin), and the pump's weight and its degree of protrusion.

Implant

During catheter placement, always calculate the implanted catheter length,
determine the catheter volume, and record this information in the patient's
medical record. The precise catheter model number, implanted catheter length
and pump model number are of critical importance in preventing a drug under-
or overdose when calculating and programming a postoperative priming bolus or
bridge bolus. Calculating and programming a postoperative priming bolus or
bridge bolus without precise information may result in a clinically significant or
fatal drug under- or overdose. A universal value does not exist which can be used
as a substitute for this knowledge.
During a pump revision which requires pump removal from the pocket and a fill
procedure, always follow the instructions in this manual for warming, emptying,
and initial filling of the pump prior to replacing the pump in the pocket.
The use of non-Medtronic components with this system can result in damage to
®
Medtronic ® components, less than adequate therapy, or increased risks to the
patient.
Implant the pump 2.5 cm (1 inch) or less from the surface of the skin.
Implantation of more than 2.5 cm can inhibit septum access or interfere with
telemetry.
Before suturing, verify that, after implantation, the pump's center reservoir fill
port and side catheter access port (if present) will be easy to palpate, that the
catheter will not become twisted or contorted, and that the catheter is secured well
away from the center reservoir fill port and side catheter access port (if present).
Medtronic - Kerkrade / PARTNUMBER : 198076-036 SHEETNR. :