PROMETRA® II PROGRAMMABLE PUMP
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Precautions
General
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Carefully read all instructions prior to use. Follow all instructions.
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Certain equipment may cause electrical noise, which may interfere with programming. If
suspected, move the patient from the suspected source of interference to facilitate the
programming procedure. Examples of equipment that may cause interference include cathode ray
tube (CRT) monitors and large electric motors.
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Do not use accessories that are not referenced in these instructions for use. Only use devices and
accessories that are referenced for use with the Prometra® II Programmable Pump in these
instructions.
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Safety and effectiveness for use in pediatric patients under 22 years old has not been investigated
or established.
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The effects of implanting this device in patients with other implanted medical devices, other than
neurostimulators, are unknown.
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Pain on injection that was not noted during previous injections may be an early sign of infection.
Implant
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Implantation of this device and subsequent use, reprogramming, and refill should only be
conducted by qualified medical personnel specifically trained for surgical implantation, use, and
maintenance of the device. Use of this device by non-qualified or untrained personnel could lead
to serious consequences involving under- or over-dosage of Infumorph. In the event of over-
dosage, refer to the approved Infumorph labeling for appropriate treatment.
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The pump and catheter system should be implanted carefully to avoid any sharp or acute angles,
which could compromise the patency of the catheter lumen.
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Over-pressurization can damage the catheter. Small syringes can generate very high pressures and
may damage the catheter or catheter connection. Do not use a syringe smaller than 10 mL when
accessing the catheter access chamber.
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If therapy is discontinued for an extended period, the pump should be emptied of Infumorph and
filled with a preservative-free 0.9% sterile saline solution and programmed to a low infusion rate to
maintain catheter patency.
Device Compatibility
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Pump accessories.
Only use the Prometra II Programmable Pump with the accessories listed in
these instructions for use. Use of alternate accessories may result in damage to Prometra II
components, less than adequate therapy, or increased risks to the patient.
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Pump.
Only use with Prometra Programmer.
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Alcohol.
Do not use alcohol on any part of the pump or catheter system. Alcohol is neurotoxic.
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Contrast media.
Do not inject contrast media into the refill reservoir since this may damage the
pump or impair pump function.
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External devices.
Do not connect any external devices or pumps to the Prometra II Pump.
Pressures generated by an external pump could damage the implanted pump/catheter system and
result in serious patient injury or death.
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Therapeutic ultrasonics or lithotripsy -
Use of therapeutic ultrasonic devices, such as
