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Quick Reference and Troubleshooting Guide Impella Heart

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Quick Reference and Troubleshooting Guide Impella Heart Quick Reference and Troubleshooting Guide Impella® Heart Pump with Automated Impella® Controller Function Impella Heart Pump Positioning Purge System Management This is not a replacement for the Instructions for Use Manual This troubleshooting guide is for use with the Automated Impella Controller with Software v6 and higher Table of Contents INDICATIONS AND SAFETY INFORMATION ..................................................... 4 AUTOMATED IMPELLA® CONTROLLER ............................................................. 6 IMPELLA 2.5® AND IMPELLA CP® ....................................................................... 8 IMPELLA 5.0® AND IMPELLA LD® .....................................................................12 IMPELLA RP® .......................................................................................................16 IMAGING THE IMPELLA DEVICES .....................................................................20 TROUBLESHOOTING ...........................................................................................24 3 Indications and Safety Information INDICATIONS FOR USE High-Risk PCI The Impella 2.5®, Impella CP® and Impella CP® with SmartAssist® Systems are temporary (≤ 6 hours) ventricular support devices indicated for use during high-risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5, Impella CP, and Impella CP with SmartAssist Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events. Cardiogenic Shock The Impella 2.5®, Impella CP®, Impella CP® with SmartAssist®, Impella 5.0® and Impella LD® Catheters, in conjunction with the Automated Impella® Controller (collectively, “Impella® System Therapy”), are temporary ventricular support devices intended for short term use (≤ 4 days for the Impella 2.5, Impella CP, and the Impella CP with SmartAssist, and ≤ 14 days for the Impella 5.0, and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP). The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function. Important Risk Information for Impella devices CONTRAINDICATIONS The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0 and Impella LD are contraindicated for use with patients experiencing any of the following conditions: Mural thrombus in the left ventricle; Presence of a mechanical aortic valve or heart constrictive device; Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less); Moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); Severe peripheral arterial disease precluding placement of the Impella System; Significant right heart failure*; Combined cardiorespiratory failure*; Presence of an Atrial or Ventricular Septal Defect (including post-infarct VSD)*; Left ventricular rupture*; Cardiac tamponade* 4 * This condition is a contraindication for the cardiogenic shock indication only. Indications and Safety Information POTENTIAL ADVERSE EVENTS Acute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Myocardial infarction, Renal failure, Thrombocytopenia and Vascular injury In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices. Visit www.abiomed.com/important-safety-information to learn more. Impella RP® The Impella RP® System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. Important Risk Information for Impella RP System CONTRAINDICATIONS The Impella RP System is contraindicated for patients with the following conditions: Disorders of the pulmonary artery wall that would preclude placement or correct positioning of the Impella RP device. Mechanical valves, severe valvular stenosis or valvular regurgitation of the tricuspid or pulmonary valve. Mural thrombus of the right atrium or vena cava. Anatomic conditions precluding insertion of the pump. Presence of a vena cava filter or caval interruption device, unless there is clear access from the femoral vein to the right atrium that is large enough to accommodate a 22 Fr catheter. POTENTIAL ADVERSE EVENTS The potential adverse effects (eg, complications) associated with the use of the Impella RP System: Arrhythmia, Atrial fibrillation, Bleeding, Cardiac tamponade, Cardiogenic shock, Death, Device malfunction, Hemolysis, Hepatic failure, Insertion site infection, Perforation, Phlegmasia cerulea dolens (a severe form of deep venous thrombosis), Pulmonary valve insufficiency, Respiratory dysfunction, Sepsis, Thrombocytopenia, Thrombotic vascular (non-central nervous system) complication, Tricuspid valve injury, Vascular injury, Venous thrombosis, Ventricular fibrillation and/or tachycardia. In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella RP. Visit www.abiomed.com/important-safety-information to learn more. 5 Automated Impella® Controller Features DISPLAY SCREEN SOFT BUTTONS MUTE ALARM FLOW CONTROL POWER INDICATOR DISPLAY SELECTOR KNOB PURGE MENU MENU PURGE DISC CATHETER PLUG PURGE CASSETTE PURGE CASSETTE DOOR (open) 6 Automated Impella® Controller Home screen Catheter System Date AIC Serial Number Serial Number and Time and Software Rev. Alarm MUTE Window Soft Central DISPLAY Button Display Labels Area PURGE SYSTEM Impella Flow MENU 2.7 Max ________________________ 2.3 Min 2.5 L/min Purge Flow: 20.0 ml/hr 100% Flow Area Purge System Area System Power Area 7 Impella 2.5® Impella CP® Heart Pumps 8 Impella 2.5® or Impella CP® Device in the Heart 9 Fr Catheter Shaft Motor Open Pressure Area Blood Outlet Area (In aorta) Cannula 12 Fr - Impella 2.5 Blood Inlet Area (In ventricle) 14 Fr - Impella CP Pigtail 9 Correct Impella 2.5® or Impella CP® Device Placement MUTE ALARM 1 Placement FLOW Signal CONTROL Placement Signal: (mmg) Aortic 19 P-8 (93) DISPLAY -2 1 sec. 14 Motor Current (mA) PURGE MENU Motor Current: 4 Pulsatile (4) 4 1 sec. Impella Flo Purge System System Poer MENU 2.5 Max Purge Flo 1.2 mlhr 1. Min 2.1 Lmin Purge Pressure 593 mmg 1 10 Modes of Operation (Expected mean flow rate relative to P-Level) P-Level Impella 2.5 *Flow (L/min) Impella CP *Flow (L/min) P-0 0.0 0.0 P-1 0.0 – 1.1 0.0 – 1.9 P-2 0.8 – 1.5 1.1 – 2.1 P-3 1.1 – 1.7 1.6 – 2.3 P-4 1.3 – 1.8 2.0 – 2.5 P-5 1.5 – 1.9 2.3 – 2.7 P-6 1.7 – 2.1 2.5 – 2.9 P-7 1.8 – 2.2 2.9 – 3.3 P-8 2.1 – 2.4 3.1 – 3.4 P-9 2.1 – 2.5 3.3 – 3.7 *Flow rate can vary due to suction or incorrect positioning. 11 Impella 5.0® Impella LD® Heart Pumps 12 Impella 5.0® and Impella LD® Devices in the Heart Impella 5.0 Heart Pump 9 Fr Catheter Shaft Motor Differential Pressure Sensor Blood Outlet Area (In aorta) 21 Fr Cannula Blood Inlet Area (In ventricle) Pigtail Rear Silicone Plug Ligature Front Silicone Plug Penetrating Suture Impella LD Heart Pump 13 Correct Impella 5.0® and Impella LD® Device Placement MUTE ALARM 60 Placement FLOW Signal CONTROL Placement Signal: (mmg) Pulsatile 352 P-9 (1) DISPLAY -2 1 sec. 1 Motor Current (mA) PURGE MENU Motor Current: 9 Pulsatile (45) 0 1 sec. Impella Flo Purge System System Poer MENU 5.2 Max Purge Flo 11. mlhr 4. Min 4.9 Lmin Purge Pressure 49 mmg 1 14 Modes of Operation (Expected mean flow rate relative to P-Level) Flow Rate L/min *Flow Rate Revolutions Per P-Level MAP 60-100 (L/min) Minute (rpm) P-0 0.0 0.0 0 P-1 0.0 – 0.1 0.0 – 1.4 10,000 P-2 0.7 – 2.1 0.5 – 2.6 17,000 P-3 1.2 – 2.7 0.5 – 3.1 20,000 P-4 1.9 – 3.1 0.9 – 3.4 22,000 P-5 2.8 – 3.5 1.4 – 3.7 24,000 P-6 3.3 – 3.8 1.8 – 4.0 26,000 P-7 3.7 – 4.1 2.6 – 4.4 28,000 P-8 4.1 – 4.5 3.4 – 4.7 30,000 P-9 4.7 – 5.1 4.2 – 5.3 33,000 *Flow rate can vary due to suction or incorrect positioning. 15 Impella RP® Heart Pump 16 Impella RP® heart pump Device in heart Outlet Area in PA Inlet Area in IVC Femoral Vein Insertion 17 Correct Impella RP® Device Placement MUTE ALARM 60 Placement FLOW Signal CONTROL Placement Signal: (mmg) Pulsatile 2 P-8 (44) DISPLAY -2 1 sec. 1 Motor Current (mA) PURGE Motor Current: MENU Pulsatile 4335 (3) 0 1 sec. Impella Flo Purge System System Poer MENU 3.9 Max Purge Flo 9.2mlhr 3.5 Min 3. Lmin Purge Pressure 495 mmg 1 18 Modes of Operation (Expected mean flow rate relative to P-Level) P-Level *Flow Rate (L/min) P-0 0.0 P-1 0.0 – 1.2 P-2 0.0 – 1.6 P-3 0.0 – 2.0 P-4 1.3 – 2.9 P-5 1.6 – 3.1 P-6 2.4 – 3.5 P-7 3.0 – 4.0 P-8 3.4 – 4.2 P-9 3.9 – 4.4 *Flow rate depends on preload and afterload and can vary due to suction or incorrect positioning. 19 IMAGING THE IMPELLA DEVICES 20 21 Correct Left-sided Impella® Device Position as Seen on TEE/TTE TEE of Impella Catheter Checklist for proper positioning: Impella® Catheter LA outlet area Mitral valve • Catheter inlet area 3.5 cm below Location of mitral chordae aortic valve annulus.
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