Publicidad
Idiomas disponibles
Idiomas disponibles
WARNING: Based on studies carried out by Codman that evaluated precipitation
of Morphine Sulfate for Intrathecal Injection at varying pH levels, the use
of preservative-free morphine sulfate solutions with pH levels above 6.5 is
not recommended for these pumps. In particular, we have found that higher
concentrations of morphine sulfate solutions (>10 mg/mL) might be more
susceptible to precipitation when the pH levels of the drug are at or near the
upper pH limits specified in USP requirements for this drug (i.e., at or near pH 6.5).
Assess the 0.9% preservative-free sodium chloride injection diluent for pH levels
to assure that it will not adversely elevate the pH of the final drug solution to be
placed into the pumps. Observe the mixtures for any evidence of precipitation
formation prior to introducing them into the pumps. The above is particularly
important when higher concentrations of morphine sulfate are being used in
the pump.
Precipitation of morphine could result in an accumulation of the precipitates in the
flow path causing possible slowing or stoppage of flow through the flow-restrictor
chip. This can lead to inadequate pain relief and/or the need to remove and
replace the pump.
Contraindications
•
The pump is contraindicated in the presence of active or incompletely
treated infection.
•
Implant and secure the pump at a maximum depth of 2.5 cm (from top of the
pump to the surface of the skin). Do not use the pump if the implanted depth
will be more than 2.5 cm.
•
The pump is contraindicated if the patient's body size is insufficient to accept
the bulk and weight of the pump.
•
The pump is contraindicated when conservative treatment is appropriate.
•
The pump is contraindicated in the presence of spinal anomalies that might
complicate the implantation and fixation of an intraspinal catheter.
In addition, observe all contraindications relating to the use of the prescribed drug.
WARNINGS
General Warnings
•
Do not modify or change the pump. Unauthorized changes or modifications
to the pump might cause a malfunction that could result in serious patient
injury or death and could void the user's authority to operate the equipment.
•
Examine the temperature indicator before preparing the pump for
implantation. The indicator is a plastic rectangle with a yellow label. It is in the
bottom of the pump box, below the rigid plastic that houses the pump.
4
" " = OK
Note: The temperature indicator contains electronic components and
a battery. Comply with local regulations regarding disposal.
•
Carefully consider the use of other devices and therapies in conjunction
with the drug pump, due to potential interactions. See Appendix B: Effects of
Electromagnetic Interference.
•
Remove the pump before burial or cremation. In some countries, removal
of battery-powered implantable devices is mandatory before burial because
of environmental concerns. The cremation process can cause the pump to
explode. Do not resterilize or reimplant an explanted pump.
•
During MRI exposure, the MedStream Programmable Infusion Pump may
experience a reset event that will stop the infusion and elicit an audible alarm
or beeping. This reset event does NOT cause loss of memory data. Upon
termination of the MRI procedure, interrogate the MedStream Programmable
Infusion Pump with the MedStream Control Unit to obtain the pump's current
status. If the infusion program has stopped, restart the program using the
MedStream Control Unit. If the physician is unable to restart the pump after
an MRI, contact your local Codman representative. For more information, see
Magnetic Resonance Imaging (MRI) Safety Information, page 5.
•
Use only Codman accessories with the MedStream pump; damage to the
pump or failure of the system to function as intended might occur.
•
Follow product instructions for initial pump preparation, implantation,
initial filling, programming, refilling, and delivering a bolus (either injected or
programmed). Only qualified medical personnel must perform these tasks.
Improper use of implanted programmable infusion pumps could result in drug
under- or overdose.
•
Before closing incisions, make sure that the central port and bolus port
of the implanted pump can be palpated, that the catheter(s) will not become
twisted or contorted, and that the catheter(s) will not obstruct the central port
or the bolus port.
"X" = DO NOT IMPLANT
Publicidad
