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PRECAUTIONS
General Precautions
•
Inspect the contents of the pump and O.R. prep kit carefully. Do not use if:
the package or seal appears damaged or open
the contents appear damaged
the expiry date has passed
the temperature indicator shows an "X"
•
Use sterile technique in all phases of handling this product.
•
Be aware that the MedStream pump might be unable to communicate with
the control unit if the pump is in the vicinity of another metallic implant.
•
Leave a 50 cm space between pumps if implanting more than one MedStream
pump in a patient. Implanting MedStream pumps nearer than 50 cm can cause
occasional interruption of communications between the pump and the control unit.
•
Be aware that communications between the pump and the control unit might
be interrupted if the patient has another implant that communicates via radio
frequency, such as a pacemaker.
•
To begin drug delivery, program the daily dose by using the control unit.
The infusion pump will not begin to deliver the drug solution until the dosage
parameters are set.
•
Do not use an open syringe when emptying the pump. The drug reservoir
contents might be ejected because they are under significant pressure.
•
Use only preservative-free sterile solutions for intrathecal applications.
•
Provide the patient with complete information concerning all aspects of
infusion drug therapy.
•
If discontinuing drug therapy for a prolonged period of time, empty the
pump of the drug solution and refill it with preservative-free sterile solution
of 0.9% sodium chloride, following the prescribed refill schedule to maintain
a patent fluid pathway.
•
Bench testing has shown that the pump settings and functioning are not
affected by exposure to radio transmitters such as security screening or anti-
theft devices. The patient should report any changes in the effectiveness of
therapy after exposure to such environments.
•
Do not place the pump on a metal surface or near massive amounts of metal
when using the control unit for preoperative preparation.
•
Do not use diathermy in the area of the pump, since this could result in
permanent pump damage and patient injury. Subjecting the pump to high
temperatures will result in a higher flow rate.
If therapeutic diathermy is required, take the following steps to minimize
patient risk:
stop the pump
maintain therapy by using an alternative drug delivery method, such as an
external drug pump
When the diathermy treatment has ended:
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.
•
Therapeutic hypothermia: Be aware that subjecting the pump to low
temperatures will result in a lower flow rate.
If therapeutic hypothermia is required, take the following steps to minimize
patient risk:
stop the pump
maintain therapy by using an alternative drug delivery method, such as an
external drug pump
When the hypothermia treatment has ended and patient is at normal body
temperature:
restart the pump
check the pump status to ensure correct functioning
•
Do not use high intensity ultrasonic devices (e.g., lithotripsy) in the area of
the pump, since this could result in permanent pump damage and patient
injury. Damage to the pump might not be immediately detectable. After exposure
to high intensity ultrasonic fields, 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.
•
Do not direct high radiation sources (such as gamma or cobalt 60 radiation
therapy) at the pump. High radiation can damage the pump circuits, including
the memory. This damage can cause the pump to stop functioning correctly
and could result in a drug overdose or underdose, or loss of therapy. In
such instances, pump replacement will be required. If it is necessary to use
radiation therapy near the pump, place lead shielding over the pump to
prevent damage. Check the pump status after exposure to ensure correct
functioning of the pump. 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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