Codman MedStream Manual Del Usuario página 3

ENGLISH
IMPORTANT INFORMATION
Please Read Before Use
MedStream™ Programmable Infusion System
Catalog No. 91-4200 & 91-4201
MedStream Pump, Pump Catheter
OR Prep Kit
An Overview of This Manual
This manual contains technical information and instructions for preparing and
implanting the MedStream pump, and pump catheter.
Additional system information is available from these sources:
– Step-by-step instructions for using the control unit to test the new
pump before implantation, initialize patient therapy, and perform
therapy maintenance after implantation are contained in the MedStream
Implantable Infusion System Programming Guide
– A list of error messages for both the pump and the control unit are
contained in the MedStream Programming Guide
– Instructions for use for the MedStream Control Unit and the battery
charger are packaged with the control unit
– List of compatible catheters, refill kits, bolus kits, and other accessories
are available from your Codman representative
– Implantation instructions and other information about the intraspinal
catheter are packaged with the catheter
– Refilling instructions are packaged with the MedStream Refill Kit and the
MedStream Programming Guide
– Instructions for manual delivery of a bolus are packaged with the
MedStream Bolus Kit
– Drug therapy information is available in the drug labeling
Brief Product Description
CAUTION: Do not prepare or implant the MedStream Pump without ensuring
a thorough familiarity with the information contained in this manual, the control unit
instructions and the MedStream Programming Guide (#914282). Failure to adhere
to these instructions can result in patient complications ranging from failure of the
intended therapy to drug underdose or overdose.
The MedStream Programmable Infusion Pump is part of a system for the
intrathecal delivery of selected drugs for pain management or relief of spasticity.
The implantable components of the system include the infusion pump, pump
catheter, connector and strain-relief sleeve. The accessories needed to prepare
the pump for implantation are included with the pump in the O.R. prep kit.
The pump must be connected to a suitable intraspinal catheter. The following
intraspinal catheters are designed for use with the MedStream pump:
®
CODMAN Intraspinal Catheter Kit (REF 60-2918)
SureStream™ Intraspinal Catheter Kit (REF 70020)
The MedStream Control Unit (REF 91-4205) is an external part of the system
that is required to prepare the pump for implantation, and to program the daily
dosage postoperatively. The control unit uses radio frequency to create two-way
communication with the pump. It is used to retrieve status information from and
transmit programming changes to the pump. The control unit also must be used
each time the reservoir is refilled.
Indications
The MedStream Programmable Infusion Pump is indicated for the chronic
intrathecal infusion of:
• Preservative-free morphine sulfate sterile solution (4.0 pH to 6.5 pH) in the
treatment of chronic intractable pain (benign or malignant) in adult patients
• Baclofen injection sterile solution (5.0 pH to 7.0 pH) in the treatment of
severe spasticity in adult and pediatric patients
Use preservative-free sterile solution of 0.9% sodium chloride (4.5 pH to 7.0 pH) to
achieve the physician-prescribed drug concentration.
WARNING: Use only the drugs and diluent listed above with the MedStream
pump. Using incompatible or contaminated (out of specification) drug solutions
can damage or obstruct the pump flow restrictor chip and cause an increase or
decrease in flow rate. This can lead to serious complications, including overdose,
underdose, and death.
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