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