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1 INDICATIONS, CONTRAINDICATIONS,

AND POTENTIAL ADVERSE EVENTS

INDICATIONS (UNITED STATES) ...................................................................... 1.1

CONTRAINDICATIONS (UNITED STATES)…................................................... 1.1

POTENTIAL ADVERSE EVENTS (UNITED STATES) ......................................... 1.2

Содержание Impella RP

Страница 1: ...ederal law USA to provide circulatory assistance for up to 14 days in pediatric or adult patients with a body surface area 1 5 m2 who develop acute right heart failure or decompensation following left...

Страница 2: ...s using the Automated Impella Controller Information contained in this document is subject to change without notice 2012 Abiomed Inc All rights reserved The ABIOMED logo and ABIOMED are registered tra...

Страница 3: ...l Drive Danvers MA 01923 978 777 5410 voice 978 777 8411 fax clinical abiomed com email Abiomed Europe GmbH Neuenhofer Weg 3 52074 Aachen Germany 49 241 8860 0 voice 49 241 8860 111 fax europe abiomed...

Страница 4: ...andthe23FrPeel awayIntroducer 5 14 PurgeCassetteProcedures 5 15 TroubleshootingthePurgeSystem 5 18 PatientWeaning 5 20 RemovingtheImpella RP Catheter 5 20 6 CLINICALEXPERIENCE Pivotal ClinicalStudy De...

Страница 5: ...ure5 9 Entering Purge Fluid Information 5 8 Figure5 10 ConnectingthePurgeTubingtotheConnector Cable 5 9 Figure5 11 Impella RP SystemConfiguration 5 9 Figure5 12 MaximumPerformanceLevel 5 12 Figure5 13...

Страница 6: ...e system and describes its major components and features Section 4 Using the Automated Impella Controller describes the controls and various screen types on the Automated Impella Controller Section 5...

Страница 7: ...1 INDICATIONS CONTRAINDICATIONS AND POTENTIAL ADVERSE EVENTS INDICATIONS UNITED STATES 1 1 CONTRAINDICATIONS UNITED STATES 1 1 POTENTIAL ADVERSEEVENTS UNITEDSTATES 1 2...

Страница 8: ...y 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 valve or pulmonary val...

Страница 9: ...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...

Страница 10: ...2 WARNINGS AND CAUTIONS WARNINGS 2 1 CAUTIONS 2 3...

Страница 11: ...nce level P0 Do NOT use saline in the purge system Do NOT use an Impella RP System if any part of the system is damaged To prevent the risk of explosion do NOT operate the Impella RP System near flamm...

Страница 12: ...pment can affect medical electrical equipment The equipment or system should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the equipment or system sho...

Страница 13: ...NOT block the cooling vents of the Automated Impella Controller while it is operating Do NOT kink or clamp any part of the Impella RP Catheter Do NOT use the Impella RP Catheter with a damaged or kin...

Страница 14: ...device failure Do NOT use the bed mount as a handle Insertion through the left femoral vein may result in repeated attempts to properly position the Impella RP which could cause excessive manipulatio...

Страница 15: ...MPELLA CONTROLLER OVERVIEW 3 1 ReusableSystem Components 3 2 Single useSystem Components 3 2 System Configuration 3 2 IMPELLA RP CATHETER 3 3 Differential PressureSensor 3 4 AUTOMATEDIMPELLA CONTROLLE...

Страница 16: ...e cannula to the outlet opening in the pulmonary artery Physicians and device operators monitor Impella RP Catheter function on the display screen of the Automated Impella Controller The intent of the...

Страница 17: ...ollowing single use components Impella RP Catheter Purge cassette Introducer kit Connector cable SYSTEM CONFIGURATION Figure 3 2 illustrates how the Automated Impella Controller connects to the Impell...

Страница 18: ...or that measures the pressure difference between the inside and outside of the cannula The pressure value is used for monitoring low during catheter operation 3 3 IMPELLA RP CATHETER The Impella RP Ca...

Страница 19: ...he Impella RP Catheter to the Automated Impella Controller through a connector cable The clear sidearm is attached to the purge cassette tubing It leads to the infusion filter the pressure reservoir a...

Страница 20: ...8 kg and can operate on its internal battery for at least 60 minutes when fully charged Using the controller the Impella RP System can be used by trained healthcare professionals in healthcare facili...

Страница 21: ...te through the catheter to the microaxial blood pump to prevent blood from entering the motor When the purge cassette is properly installed in the Automated Impella Controller the words on it are upri...

Страница 22: ...or Transmits pressure to the controller based on the purge pressure in the purge tubing a sensor in the controller measures the pressure so that it can be displayed on the screen and used by the purge...

Страница 23: ...lug The white plug at the opposite end of the cable is inserted into the blue catheter plug on the front of the Automated Impella Controller Figure 3 6 White Connector Cable The introducer kit is used...

Страница 24: ...dextrose in water with 50 IU mL of heparin is used as the purge fluid through the Impella RP Catheter Figure 3 9 Dextrose Solution The Automated Impella Controller cart holds the Automated Impella Con...

Страница 25: ...TOMATED IMPELLA CONTROLLER FEATURES 4 1 AUTOMATED IMPELLA CONTROLLER DISPLAY 4 5 PLACEMENT SCREEN 4 8 Placement Signal Waveform 4 8 Motor Current Waveform 4 9 PURGE SCREEN 4 9 Purge Flow 4 10 Purge Pr...

Страница 26: ...operating the Automated Impella Controller for the first time make sure you turn this switch on If the battery switch is not turned on the Automated Impella Controller will not be able to operate on b...

Страница 27: ...ntroller is off but plugged into AC power No light controller is off and not plugged into AC power Selector knob Rotating push button turn clockwise and counterclockwise to navigate through menu items...

Страница 28: ...of the Automated Impella Controller These features are described in Table 4 2 Purge Cassette Door Release Bed Mount Power Switch AC Fuses AC Plug Equipotential Ground Stud VGA RS 232 Jack Ethernet Jac...

Страница 29: ...vice personnel AC fuses Electrical safety device in the event of current overload AC plug Connection point on the controller for the AC power cord Power switch Button that turns the controller on or o...

Страница 30: ...low Area System Power Area Central Display Area Figure 4 3 Automated Impella Controller Display Elements Table 4 3 Automated Impella Controller Display Elements Display Element Description Alarm windo...

Страница 31: ...E SYSTEM or EXIT PURGE SYSTEM Brings up the Purge System menu for changing the purge fluid purge cassette or purge system or de airing the purge system EXIT Exits the current procedure MENU MENU Bring...

Страница 32: ...e purge system is stabilizing when there is no purge cassette or when the procedure has not yet started Flow area Information about Impella RP Catheter flow is displayed in the lower left corner of th...

Страница 33: ...ment Signal mmHg 42 20 31 10 sec 60 20 1000 0 Figure 4 4 Placement Screen Figure 4 4 shows two time based waveform signals from different sources Placement signal waveform Motor current waveform PLACE...

Страница 34: ...and shows the maximum and minimum values and the average value from the samples received You can set the time scale at the bottom of that window by pressing the DISPLAY soft button PURGE SCREEN The pu...

Страница 35: ...RESSURE The purge pressure generated by the purge cassette is displayed in mmHg The standard scale for the purge pressure 0 1500 mmHg is displayed to the left of the purge pressure plot The maximum va...

Страница 36: ...ION The Li Ion batteries must be charged for 5 hours prior to system operation in order to meet the runtime requirement of 1 hour Failure to do so will yield a shorter runtime After being unplugged th...

Страница 37: ...m Configuration 5 9 INSERTING THE IMPELLA RP CATHETER 5 10 POSITIONING AND STARTING THE IMPELLA RP CATHETER 5 12 PERFORMANCE LEVELS 5 13 USE OF THE REPOSITIONING SHEATH AND THE 23 FR PEEL AWAY INTRODU...

Страница 38: ...ng and improper operation do NOT block the cooling vents of the Automated Impella Controller while it is operating The Li Ion batteries must be charged for 5 hours prior to system operation in order t...

Страница 39: ...automatically performs a system test when turned on A display bar shows the progress of the system test If the system test passes the system displays the startup screen see Figure 5 2 If the system t...

Страница 40: ...ftware version V03_10_36 Impella Controller Start up Screen New Case Press MENU or plug in new Impella catheter for case start procedure Figure 5 2 Automated Impella Controller Startup Screen The star...

Страница 41: ...heter CASE START 1 Press the MENU soft button from the startup screen Case Start is the default selection on the pop up menu that appears on the screen 2 Press the selector knob to select Case Start T...

Страница 42: ...lot to the right of the purge cassette until it snaps into place The controller will automatically begin priming the purge cassette 7 Extend the purge tubing and close the purge cassette door There is...

Страница 43: ...ctor Cable Socket black end Catheter Plug Figure 5 5 Inserting the Catheter Plug into the Connector Cable 6 Pull back on the connection to make sure that the plug has snapped into place 7 Snap the pla...

Страница 44: ...you have not already done so disconnect and discard the Y connector with the red and yellow luers from the purge tubing 12 Connect the yellow luer on the end of the purge tubing to the yellow luer on...

Страница 45: ...ose Concentration Heparin Concentration 500 ml 20 50 units ml Figure 5 9 Entering Purge Fluid Information 2 To select the default values displayed on the screen scroll to OK below the table and press...

Страница 46: ...nector cable as shown in Figure 5 10 Figure 5 10 Connecting the Purge Tubing to the Connector Cable IMPELLA RP SYSTEM CONFIGURATION Figure 5 11 illustrates the correct configuration of the Impella RP...

Страница 47: ...the femoral vein 2 Insert a 5 8 Fr introducer over the 0 035 inch guidewire provided to pre dilate the vessel 3 Remove the 5 8 Fr introducer over the 0 035 inch guidewire Insert the 8 Fr 12 Fr 16 Fr a...

Страница 48: ...atheter The physician can focus on advancing the guidewire and if the cannula needs to be hyperextended the scrub assistant is available to assist 10 Advance the catheter through the hemostatic valve...

Страница 49: ...increase the performance level icon 3 Press the selector knob to select the new performance level 4 The catheter operation icon in the lower left corner of the screen begins rotating when the Impella...

Страница 50: ...ally clot Pressure bags should not be connected to the sideport of the repositioning sheath If a pressure bag is connected the sideport must have an infusion pump or flow limiting valve in place to co...

Страница 51: ...evels between P1 and P6 the Impella RP operates with a regularly recurring rapid speed pulse This minimizes stasis and reduces the risk of thrombosis in the motor area These pulses produce peaks in th...

Страница 52: ...e end of the purge tubing as shown in Figure 5 13 Figure 5 13 Disconnecting the Y Connector from the Purge Cassette Tubing 3 Spike the fluid bag bottle 4 Select OK to deliver a bolus to the pressure r...

Страница 53: ...ect OK to deliver a bolus to the pressure reservoir so that the reservoir can maintain purge pressure during the change A progress bar shows the progress of the bolus After the bolus is delivered the...

Страница 54: ...gap in the purge cassette door when you close the door 6 The system automatically primes the purge cassette A progress bar shows the progress of the priming Once the priming is complete you are promp...

Страница 55: ...age 5 If the low purge pressure alarm still remains unresolved for more than 20 minutes this may be a sign of Impella RP Catheter damage Complete the following steps immediately a Open the performance...

Страница 56: ...pella RP Catheter HIGH PURGE PRESSURE If the purge pressure exceeds 1100 mmHg the Automated Impella Controller displays the Purge Flow Low alarm message 1 Inspect the purge system and check the Impell...

Страница 57: ...rate continue the weaning process by reducing flow rate as tolerated to 0 5 L min P1 At this flow rate there will no longer be any forward flow across the right heart 5 If the patient is maintained a...

Страница 58: ...cal Considerations 6 3 ACCOUNTABILITY OF COHORT 6 3 Study Population Demographics andBaselineCharacteristics 6 4 Procedural SupportandHemodynamic Characteristics 6 5 Primary Endpoint Results 6 7 Secon...

Страница 59: ...st implant Secondary safety endpoint was determined by the rates of the following adverse events at 30 days or discharge whichever is longer or at induction of anesthesia for a longer term therapy inc...

Страница 60: ...0 1 post PCI or post CABG General For Both Cohorts 1 Active infection two of the following WBC 12 500 positive blood culture fever 2 RA RV and or PA thrombus 3 Prosthetic valves in the right heart tri...

Страница 61: ...iothoracic surgeon selected as the Physician Medical Monitor was charged with reviewing study data in order to protect the safety and well being of human subjects and the scientific integrity of the i...

Страница 62: ...7 2 30 5 6 1 18 8 3 1 12 Body Surface Area m2 Mean SD N 1 94 0 22 30 2 01 0 23 18 1 85 0 18 12 Hypertension 80 0 24 30 77 8 14 18 83 3 10 12 Coronary Artery Disease 66 7 20 30 66 7 12 18 66 7 8 12 Co...

Страница 63: ...76 75 24 18 222 58 103 42 12 Hemoglobin g dL 10 31 2 01 30 10 09 1 79 18 10 63 2 35 12 Hematocrit 31 40 5 84 30 30 84 5 41 18 32 24 6 58 12 Plasma Free Hemoglobin mg dL 26 22 50 90 16 12 42 11 32 11...

Страница 64: ...able 6 4 All patients presented with RVF and poor hemodynamics at the time of implant despite high dose of inotropes pressors The hemodynamic profile was consistent between the two cohorts Table 6 4 S...

Страница 65: ...s though numerically high 18 30 60 of patients were predominantly related to the surgical procedure with post cardiotomy surgical bleeding accounting for 83 15 18 LVAD implantation n 10 Cohort A or he...

Страница 66: ...enous pressure CVP measured during the study Improvement in LVAD flow or LV pumping function The LVAD flow in Cohort A patients improved after the initiation of Impella RP from 3 96 0 16 L min to 4 62...

Страница 67: ...ated to use of the large bore sheath provided with the Impella RP pump Integrity of Cardiac and Valvular Structures A comprehensive echocardiographic safety analysis on echocardiographic images acquir...

Страница 68: ...the Impella RP System to provide percutaneous hemodynamic support for right heart failure had a high survival rate The 30 day survival rate in the 30 patients treated with the Impella RP System was 73...

Страница 69: ...pport to reverse shock and to restore normal hemodynamic parameters and achieved an overall survival rate of 73 at 30 days or discharge whichever is longer or to a long term therapy The Impella RP dev...

Страница 70: ...7 AUTOMATED IMPELLA CONTROLLER ALARMS ALARMS OVERVIEW 7 1 Alarm Levels 7 1 Alarm Display 7 2 Mute Alarm Function 7 2 ALARM MESSAGE SUMMARY 7 3...

Страница 71: ...alarm than the one that was muted ALARM LEVELS Alarms are divided into three levels of severity Advisory white Serious yellow Critical red Table 6 1 Alarm Levels Category Advisory Serious Critical So...

Страница 72: ...r display screen will silence the audible alarm indicator for 2 minutes for red or yellow alarms or 5 minutes for white advisory alarms When an alarm is silenced the words MUTE ALARM next to the butto...

Страница 73: ...into AC power The purge system has stopped Initiate the De air Tool and follow instructions to remove the air from the system Cause There may be a mechanical or electrical problem in the Impella RP C...

Страница 74: ...s 2 Decrease concentration of dextrose in the purge solution Check the purge line click on and make sure it is fully inserted Cause There is a problem with the purger unit driver Impella RP Catheter i...

Страница 75: ...not responded to a de air or purge procedure screen for more than 1 minute or a transfer to standard configuration screen for more than 5 minutes There is a problem with the controller electronics The...

Страница 76: ...tification only no action is required The auditory signal for the following alarm has been disabled Alarm will be listed here Controller is running on battery power Contact Abiomed Service to update I...

Страница 77: ...NICATIONSCOMMISSION FCC NOTICE 8 5 ELECTROMAGNETIC COMPATIBILITY 8 5 TRANSPORT BETWEEN HOSPITALS 8 10 Guidelines forPatient Transport 8 10 Important TransportConsiderations 8 11 FAA Advisory 8 10 TRAN...

Страница 78: ...ith inlet and outlet and pigtail at the tip Pressure present in the Impella RP Catheter and in the infusion line Impella purge cassette used for rinsing the Impella RP Catheter Reverse flow through th...

Страница 79: ...le Use by date eg use before June 1 2016 Do not reuse Sterilized using ethylene oxide Electric scrap must be disposed of separately Must not be disposed of as domestic waste Protective Earth ON OFF Al...

Страница 80: ...351 mm 13 8 in 443 mm 17 4 in 236 mm 9 3 in 508 mm 20 0 in 559 mm 22 0 in 406 mm 15 0 in 11 8 kg 26 1 lbs 13 6 kg 30 lbs 100 230 V AC nominal 47 63 Hz 1 1 A 14 4 V DC nominal lithium ion 120 VA 2 Amp...

Страница 81: ...Safety Requirements for Medical Electrical Equipment IEC 60601 1 4 2000 Edition 1 1 Consolidated Edition Medical Electrical Equipment Part 1 4 General Requirements for Safety Collateral Standard Progr...

Страница 82: ...ot expressly approved by Abiomed Inc could void the user s authority to operate this device Impella RP with the Automated Impella Controller 8 5 IEC 60601 1 Class I degree of protection CF defibrillat...

Страница 83: ...on is required Monitor Impella RP Catheter flow and patient hemodynamics to confirm normal operation The condition will resolve itself once the Automated Impella Controller is no longer exposed to the...

Страница 84: ...synthetic the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or...

Страница 85: ...saffectedbyabsorptionand reflectionfromstructures objects andpeople a Fieldstrengthsfromfixedtransmitters suchasbasestationsforradio cellular cordless telephonesandlandmobileradios amateurradio AMandF...

Страница 86: ...01 0 04 0 06 0 12 0 1 0 11 0 19 0 38 1 0 35 0 6 1 2 10 1 11 1 9 3 8 100 3 5 6 0 12 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m...

Страница 87: ...ring transport Steps should be taken to eliminate or minimize any aspect of the transport that might adversely affect these factors The Automated Impella Controller is designed to operate for 60 minut...

Страница 88: ...nd passed the EMC EMI tests as specified in IEC 60601 1 2 General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests The Automated Impella Controller does...

Страница 89: ...la Controller Patient Environment For some Automated Impella Controller alarms there is a short delay between the triggered event and the audible annunciation and visual display of the alarm ALARM DEL...

Страница 90: ...use US Up to 14 days Dimensions of Impella RP Catheter Length of invasive portion without catheter Approx 238 mm Diameter Max 7 6 mm Classification per DIN EN 60601 1 Protection class I degree of pro...

Страница 91: ...al surface to prevent falling Connect the AC power cord to an AC outlet The battery may be destroyed if the Automated Impella Controller is stored with a depleted battery CLEANING Clean the Automated...

Страница 92: ...APPENDIX A AUTOMATED IMPELLA CONTROLLER MENU STRUCTURE A 1 Overview A 1 MUTE ALARM A 1 FLOW CONTROL A 1 DISPLAY A 2 PURGE SYSTEM A 2 MENU A 3 APPENDICES...

Страница 93: ...on mutes silences active alarms It does not open another menu When you press MUTE ALARM a bell icon with an X through it replaces the words MUTE ALARM in the upper right of the display screen If no al...

Страница 94: ...ers the motor current waveform and adjusts the range accordingly Infusion opens the infusion history screen The infusion history screen which is discussed in section 4 of this manual shows the volume...

Страница 95: ...able Enable Reverse Flow Control Disable Enable Automatic Zero Disable Enable P Level Suction Control Disable Enable Audio Impella Sensor Failure Allows you to enable or disable audio for the Impella...

Страница 96: ...INDEX TO BE DEVELOPED...

Страница 97: ...Facsimile 978 777 8411 Email clinical abiomed com Abiomed Europe GmbH Neuenhofer Weg 3 52074 Aachen Germany Voice 49 241 8860 0 Facsimile 49 241 8860 111 Email europe abiomed com Clinical support 24...

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