Storage And Handling; Preimplant; Pump Preparation And Implant - Medtronic SYNCHROMED EL serie Gebrauchsanweisung

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Precautions 5

Storage and Handling

Do not expose the pump to temperatures above 43 °C (110 °F) or below 5 °C
(41 °F).
Do not implant a pump that has been dropped onto a hard surface or shows signs
of damage.
When the pump is stored at room temperature, the Low Battery Alarm may
sound; therefore, the alarm is programmed DISABLED before shipment. Before
implantation, set the Low Battery Alarm to ENABLED. If the alarm continues to
sound after the pump has been warmed to 35 °C - 40 °C (95 °F - 104 °F), DO NOT
implant; contact your local Medtronic representative.
Do not steam autoclave or flash autoclave the pump prior to implant or following
explant; the pump will explode at high temperatures.
Prior to cremation, always remove the pump and return to Medtronic; the pump
will explode at high temperatures.
Return explanted pumps to Medtronic.

Preimplant

The implanting physician/therapy specialist is responsible for choosing the
surgical procedure, techniques, and the intended therapy for the patient.
In the pediatric population, care must be taken to select an appropriate
anatomical pump site, taking into consideration available body mass, presence of
ostomies, growth and development. Whenever possible, an abdominal location is
recommended for pumps implanted for spinal delivery of medication.
Screening for drug response with implanted non-filtered access ports is not
recommended. For those patients who must be screened with such devices
because of their medical condition, extreme care should be exercised to ensure
that aseptic conditions are maintained.

Pump Preparation and Implant

Consider use of peri- and postoperative antibiotics for pump implantation and
any subsequent surgical procedure.
Allow enough time prior to implantation to purge any air from the pump's
reservoir and fluid pathway. Purging is described in the programmer's technical
manual under Programming Sequence and Data Entry Instructions.
Do not empty or fill the drug reservoir until the pump has first been warmed to
body temperature and then emptied completely. Emptying and filling a pump
that has not been warmed to body temperature or filling a pump that has not
been emptied completely can result in activation of the reservoir valve.
Initial fill at implant must not exceed 6 ml (for 10 ml pump models) or 10 ml
(for 18 ml pump models).
Use low concentration drugs during initial fill at implant.
Medtronic - Kerkrade / PARTNUMBER : 198076-036 SHEETNR. :