Codman MedStream Manual Del Usuario página 2

Table of Contents
An Overview of This Manual .......................................................................... 3
Brief Product Description ............................................................................... 3
Indications ........................................................................................................ 3
Contraindications ............................................................................................ 4
Warnings .......................................................................................................... 4
Magnetic Resonance Imaging (MRI) Safety Information ............................ 5
MRI Testing Information ................................................................................. 6
Precautions ...................................................................................................... 7
Adverse Events ................................................................................................ 9
Patient Information ....................................................................................... 10
Drug Stability Information ............................................................................ 10
Product Description ...................................................................................... 10
Pump ...................................................................................................... 10
X-ray Identification of the Implanted Pump ........................................... 11
Pump Catheter ....................................................................................... 11
O.R. Prep Kit ........................................................................................... 11
How Supplied ................................................................................................. 11
Pump Alarms ................................................................................................. 11
Instructions For Use ..................................................................................... 13
Required Equipment and Supplies .............................................................. 13
Pump Preparation Procedures .................................................................... 13
Clean Procedures ................................................................................... 13
Sterile Procedures .................................................................................. 13
A. Attach the Pump Catheter ............................................................. 13
B. Empty the Reservoir ...................................................................... 14
C. Flush the Residual Volume ("Dead Space") of the Reservoir ........ 14
D. Set Up the O.R. Prep Kit for Filling ................................................ 15
E. Fill the Reservoir ............................................................................ 15
F. Prime the Bolus Channel with Sodium Chloride Solution .............. 16
Implantation Procedure .......................................................................... 16
A. Replace an Implanted Pump .......................................................... 16
B. Prepare the Pump Pocket .............................................................. 16
C. Secure the Pump ........................................................................... 16
D. Connect the Intraspinal Catheter ................................................... 17
Postoperative Procedures ...................................................................... 17
A. Program the Pump ......................................................................... 17
B. Patient Identification ...................................................................... 17
C. Schedule the First Refill ................................................................. 17
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Technical Specifications ............................................................................... 18
Explanting the Pump ..................................................................................... 20
Warranty ......................................................................................................... 20
Appendix A Flow Rate Accuracy ................................................................. 20
Figure A-1. Flow Rate Accuracy as a Function
of Reservoir Volume ........................................................... 20
Figure A-2. Effects of Temperature on
Flow Rate Accuracy ......................................................... 21
Figure A-3. Effects of Atmospheric and Water Pressure
on Flow Rate Accuracy ...................................................... 21
Appendix B Effects of Electromagnetic Interference ................................ 22
Table B-1. Effects on MedStream Pump
from EMI-Generating Devices or Procedures .................... 23
Illustrations