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Do not use transcutaneous electrical nerve stimulation (TENS) in the area
of the pump. After exposure to TENS, check the pump status to ensure correct
functioning. Be aware that this initial check of pump status does not guarantee
that the pump is undamaged. Continue to monitor the patient for signs of
unintended change in the therapy.
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Interaction with Pacemakers and Defibrillators – The telemetry signals produced
by the Control Unit can cause sensing problems and inappropriate device
responses with an implantable pacemaker or defibrillator. Careful programming of
each system is necessary to optimize the benefit from each device.
•
Hyperbaric Therapy: Do not subject the pump to pressure above
1.5 atmospheres absolute (ATA). Pressures above 1.5 ATA could damage
the pump, which will require pump replacement. The pump flow rate is
pressure dependent; at higher ambient pressures, the flow rate is reduced.
To minimize patient risk and damage to the pump if hyperbaric therapy
above 1.5 ATA is required:
fill the pump to capacity with the MedStream Refill Kit
stop the pump
maintain therapy by using an alternative drug delivery method, such as an
external drug pump that is not sensitive to pressure
When the hyperbaric treatment has ended and pressure reaches a normal level:
restart the pump
check the pump status to ensure correct functioning. Be aware that
this initial check of pump status does not guarantee that the pump is
undamaged. Continue to monitor the patient for signs of unintended
change in the therapy.
Never subject the pump to pressures above 3.0 ATA. Such pressures might
cause a back-flow into the pump.
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Advise the patient that the effects of the industrial environment on the pump
are unknown. The patient should report any changes in the effectiveness of
therapy after exposure to environments such as electrical substations, arc
welding, and other industrial equipment.
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Advise the patient to avoid high-energy radio frequency equipment, such as
radio transmitters and security gates. The patient should report any changes in
the effectiveness of therapy after exposure to such environments.
•
Advise the patient not to go SCUBA diving or deep sea diving. Do not
subject the pump to pressure above 1.5 atmospheres absolute (ATA).
Pressures above 1.5 ATA could damage the pump, which will require pump
replacement. The pump flow rate is pressure dependent; at higher ambient
pressures, the flow rate is reduced. Never subject the pump to pressures
above 3.0 ATA. Such pressures might cause a back-flow into the pump.
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Catheter Precautions
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Use extreme care to prevent silicone catheters from coming in contact
with towels, drapes, talc, or any linty or granular surfaces. Silicone is
highly electrostatic and as a result, attracts airborne particles and surface
contaminants that could produce tissue reactions.
•
Use care when placing ligatures so as not to tie them too tightly; silicone has
a low cut and tear resistance. Use only No. 0 silk suture for securing catheters
and connectors. Smaller diameter suture and stainless steel suture may cut
or tear silicone catheters. Use non-absorbable suture to secure the pump to
the fascia.
•
Do not handle the catheters with sharp instruments. Use rubber-shod
forceps when handling the catheters. Take care not to inadvertently cut
or puncture the catheters.
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Make sure catheter placement and connections are secure. Failure
to adequately secure catheters in place can result in dislodgment or
disconnection of the catheter or obstruction of the ports. These can
cause cessation of therapy or delivery of drug to the pump pocket
or subcutaneous tissue.
•
Trim catheters only after placement. When trimming catheters, leave an
extra amount to help ensure that no tension is placed on the catheters when
the patient moves.
•
During implantation, make sure that catheters will not become kinked or
occluded due to knots, tight geometries, or a tortuous position. To prevent
dislodgment or kinking, always use an anchor to secure the intraspinal catheter
to surrounding tissue.
•
Be aware that a gap on x-ray of 1 mm to 2 mm between the pump and the
pump catheter is normal.
Pump Filling Precautions
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Be aware that only qualified medical personnel must refill the pump on the
prescribed schedule.
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Do not aspirate contents of the drug reservoir when filling or emptying the
pump. This can damage the pump.
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Use only the filling needle provided with the MedStream Refill Kit for filling
and refilling MedStream pumps. This needle is designed specifically for use
with this pump. Use of other needles can damage the central port or result in a
failure to administer solution appropriately.
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Ensure that all luer lock connections are secure when assembling the OR prep kit.
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