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Abiomed Impella 2.5 Instructions For Use Manual

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Contents
  1. instructions for use
  2. Table Of Contents
  3. Table Of Contents
  4. Table Of Contents
  5. Warnings
  6. Indications (United States)
  7. Potential Adverse Events (United States)
  8. Cautions
  9. Overview
  10. Table 3.1 Impella ® Set-up and Insertion Kit Components
  11. Impella ® Catheter
  12. Table 3.3 Impella ® Catheter Components
  13. Figure 3.6 Electrical Signal Generated by the Cardiac Cycle
  14. Automated Impella ® Controller
  15. Purge Cassette
  16. Table 3.4 Purge Cassette Components
  17. Accessories
  18. Figure 3.16 Placement Guidewire
  19. Controller Features – Front View
  20. Controller Features – Side Views
  21. Home Screen
  22. Placement Screen
  23. Purge Screen
  24. Infusion History Screen
  25. Mobile Operation
  26. Pre-support Evaluation
  27. Startup
  28. Case Start
  29. Figure 5.5 Inserting the Catheter Plug into the Connector Cable
  30. Figure 5.7 Priming the Impella Purge Lumen
  31. Figure 5.9 Priming the Placement Signal Lumen
  32. Figure 5.11 Entering Purge Fluid Information
  33. Figure 5.12 Connecting the Purge Tubing to the Connector Cable
  34. Impella ® 2.5 Catheter Insertion (Wired)
  35. Figure 5.15 Inserting the Diagnostic Catheter
  36. Figure 5.17 Loading the Catheter on the Guidewire without the EasyGuide Lumen and Aligning the Placement Guidewire
  37. Figure 5.19 Aortic Waveform on Placement Signal Screen
  38. Wireless Insertion of the Impella ® 2.5 Catheter
  39. Impella CP ® Catheter Insertion
  40. Figure 5.21 Inserting the Diagnostic Catheter
  41. EasyGuide Lumen and Aligning the Placement Guidewire
  42. Figure 5.25 Aortic Waveform on Placement Screen
  43. Catheter
  44. Figure 5.27 Correct Positioning If Second Graft Lock Required
  45. Figure 5.28 Closing the Graft Lock
  46. Figure 5.29 Releasing the Graft Lock
  47. Alternate Insertion Technique for the Impella ® 5.0 Catheter
  48. Figure 5.31 Guidewire Placement
  49. a Sidearm Graft
  50. Figure 5.34 Waveform as Catheter is Advanced into the Aorta
  51. Figure 5.35 Pulsatile Waveform on Placement Signal Screen
  52. Catheters
  53. Figure 5.38 Ventricular Waveform on Placement Signal Screen
  54. Figure 5.40 Adjusting P-level
  55. from the Set-up Configuration
  56. Figure 5.43 Waveform as Catheter is Advanced into the Aorta
  57. Figure 5.44 Pulsatile Waveform on Placement Screen
  58. Figure 5.46 Confirming Placement on the Placement Signal Screen
  59. Figure 5.47 Selecting P-Level
  60. Figure 5.48 Confirming Placement on the Placement Signal Screen
  61. LD Catheter After Implantation
  62. Purge Cassette Procedures
  63. Tubing
  64. Troubleshooting the Purge System
  65. Patient Weaning
  66. Figure 5.53 Loosening the Tuohy-Borst Valve
  67. Summary of Primary Clinical Studies
  68. Table 6.1 Baseline Demographics and Characteristics
  69. Figure
  70. Summary of Supplemental Clinical Information
  71. Patients Likely to be Eligible for RCTs vs. Patients Likely to be Excluded from RCTs ("Salvage" Patients)
  72. Figure 6.11 Kaplan-Meier Curve Estimates for 30-Day Survival
  73. Figure 6.14 Decrease in Inotropes and Pressors (Post-Device Placement) for RECOVER I Patients
  74. Cardiac Shock After Open Heart Surgery
  75. Figure 6.15 RECOVER I Enrollment
  76. Figure 6.16 Kaplan-Meier Survival Curve for Freedom from Death (to 1 Year)
  77. Figure 6.27 Flow Diagram of the Distribution of the AB5000 LVAD PCCS Patient Cohort
  78. Figure 6.30 Decrease in Inotropes and Pressors (Post-Device Placement) for RECOVER I Patients
  79. Patient Management Overview
  80. Transport Within the Hospital
  81. ECG Interference
  82. Impella Stopped
  83. Hemolysis
  84. Table 7.1 Guide for Managing Hemolysis in Various Circumstances
  85. Figure 7.13 Displacing Air During Flush Solution Change Out Procedure
  86. Surgical Mode
  87. Transferring from the Automated Impella ® Controller to a New Automated Impella ® Controller
  88. Emergency Shutdown Procedure
  89. Alarms Overview
  90. Figure 8.1 Alarm Window
  91. Alarm Message Summary
  92. Terminology, Abbreviations, and Symbols
  93. Equipment Design
  94. Equipment Classifications
  95. Electromagnetic Compatibility
  96. Transport Between Hospitals
  97. Alarm Delay Information
  98. White Connector Cable
  99. Impella ® 2.5 Catheter Dimensions
  100. Impella ® 5.0 Catheter Dimensions
  101. Cleaning
  102. menu structure
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This manual is suitable for:
Impella 2.5Impella 5.0Impella CPImpella LD
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