Postimplant; Precautions; Qualifications - Medtronic SYNCHROMED EL serie Gebrauchsanweisung

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4 Warnings; Precautions

Postimplant

Improper injection through the side catheter access port or into the pump pocket
can result in a clinically significant or fatal drug overdose. Refer to "Appendix C:
Emergency Procedures" in this manual or the drug labeling for specific drug
overdose symptoms and methods of management. To prevent overdose when
filling or refilling the pump, or injecting into the side catheter access port of the
pump:
• identify pump model and reservoir volume size,
• identify location of the center reservoir fill port and side catheter access
port (if present),
• use the appropriate template, instructions and other accessories provided
with a Medtronic
Port Kit,
• use a 3.8 cm (1.5 inch) (minimum), 22-gauge Huber-type needle (for filling
the center reservoir fill port), or a 3.8 cm (minimum), 25-gauge needle (for
accessing the side catheter access port), and
• use other medical procedures as appropriate (e.g., fluoroscopy, glucose
check of the aspirate, etc.) to verify location of pump reservoir/side
catheter access port (if present) septum.
If therapy is discontinued for an extended period of time, to maintain a patent
fluid pathway, it is recommended that the pump be filled with preservative-free
saline and programmed to infuse at the minimum rate of 0.048 ml/day. Do not
stop the pump during periods of nontherapy.
When injecting contrast media into the intrathecal space, only use a contrast
medium indicated for intrathecal administration. Failure to use an indicated
contrast medium may result in adverse events including but not limited to
extreme pain, cramps, seizures, and death.

PRECAUTIONS

Qualifications

SynchroMed ® EL pumps must be implanted only by qualified physicians.
Individuals trained in the operation and handling of the SynchroMed
Infusion System must coordinate the preparation of the pump for implantation.
The pump must be refilled on a prescribed schedule only by qualified personnel.
All refills must be in compliance with the procedures described in the appropriate
refill kit technical instructions.
Side catheter access port procedures must be conducted only by qualified
personnel. All injections through the side catheter access port must be in
compliance with the procedures described in the appropriate catheter access port
kit technical instructions.
For a complete list of model numbers and components compatible with the
pump, see the System Components Sheet packaged with this manual in the pump
shelf box.
Medtronic - Kerkrade / PARTNUMBER :
® Model 8551 Refill Kit or Model 8540 Catheter Access
198076-036
® EL
SHEETNR. :