Warnings; General - Medtronic SYNCHROMED EL serie Gebrauchsanweisung

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Warnings

WARNINGS

General

Improper use of implanted, programmable infusion pumps could result in
drug overdose. Users must comply with product instructions for initial pump
preparation, programming, implantation, initial filling, refilling, and injecting
into the side catheter access port (if present) of the pump. Technical errors may
result in a return of underlying symptoms, drug withdrawal symptoms, or a
clinically significant or fatal drug overdose.
A significant amount of drug may be present in the pump's reservoir, pump
tubing, side catheter access port, and catheter. Caution must be used to prevent
drug overdose during injections through the side catheter access port or when
changing concentrations or solutions in the pump reservoir.
• To prevent drug overdose during injections through the side catheter
access port, aspirate approximately 1 to 2 ml from the catheter to ensure
drug removal unless contraindicated (e.g., vascular applications). Refer to
the appropriate catheter technical manual for specific catheter volume.
• To prevent drug overdose when changing concentrations or solutions in
the reservoir, program a bridge bolus when appropriate and always rinse
the reservoir when decreasing concentrations or changing solutions. Refer
to Appendices A and B for these procedures.
This device is only approved for drugs listed under Indications. Use of non-
indicated drugs with this product can cause pump failure.
Make sure the pump is adequately warmed during the empty and initial fill
procedures prior to implant and during the Purge Bolus.
• Failure to warm the pump and maintain the temperature 35 °C - 40 °C
(95 °F - 104 °F) prior to and during the empty and initial fill procedures
can result in incomplete emptying and subsequent activation of the
reservoir valve.
• The pump will not accurately infuse below 35 °C (95 °F). If not adequately
warmed, the programmed Purge Bolus may not remove air in the pump
tubing and fluid pathway. Fluid delivery indicates that the pump is
functioning.
Do not attempt to force fluid into the pump reservoir if the reservoir valve has
been activated. Extreme pressure following activation of the reservoir valve
may result in procedural delays or pump damage.
Confirm that the pump calibration constant displayed on the programmer's
screen after reading the pump status is the same as the calibration constant value
printed on the sterile package. If the calibration constant has changed, contact
your local Medtronic representative.
The effects of implanting this device in patients with other implantable
programmable devices are unknown.
Medtronic - Kerkrade / PARTNUMBER : 198076-036 SHEETNR. :