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Impella® 2.5

1. 5 17 MODES OPERATION ento 5 19 Flow 5 19 P level o nasaan 5 19 USE OF THE REPOSITIONING SHEATH AND THE PEEL AWAY INTRODUCER ccoo ici rca 5 20 TRANSFER TO STANDARD CONFIGURATION een 5 21 PURGE CASSETTE PROCEDURES eene 5 22 Change PURGE SVS COM 5 23 Change Purge Fluid entente reiten 5 24 Change Purge Cassette seen een 5 25 De A PUNGG SM rra nica ari 5 25 TROUBLESHOOTING THE PURGE 5 5 26 LOW PUNGE 655 r 5 26 Purge System Open canina ainia 5 27 High Purge Pressure Purge System Blocked 5 27 PATIENT WEANING lt lt sisi ao 5 28 Rapid WENDO cs iecit er n P RR i Re 5 28 STOW TED E 5 28 REMOVING THE IMPELLA CATHETER eene 5 29 Removing the Impella with the Introducer in 5 29 Removing the Impella Secured with the Repositioning Sheath 5 29 PRE SUPPORT EVALUATION Before initiating the procedure evaluate the patient for factors that may prevent su
2. 34 Automated Impella Controller Front 3 6 Purge Cassette canne eee necne 3 7 White Connector Cable 3 9 Modulo nin 3 9 0 018 inch 260 cm Placement 3 9 Dextrose ee 3 10 Automated Impella Controller 3 10 Automated Impella Controller Features Front View 4 2 Automated Impella Controller Features Side Views 4 4 Home Md 4 6 Place mensa 4 9 A e 4 10 DUO SOMO neenon 4 12 Automated Impella Controller Power Switch 5 3 Automated Impella Controller Startup Screen 5 4 initial Case Start Sereen ect 5 5 nserting Purge Cassette into Automated Impella Controller 5 6 nserting the Catheter Plug into the Connector Cable 5 7 Snapping Plastic Clip to Connector 5 7 Priming the Impella Purge 5 8 Connecting the Luer s to the Impella Catheter 5 8 Priming the Placement Signal Lumen 5 9 Squeezing the White Flush Valve to Prime the Placement Signal Lumen 5 9 Entering Purge Fluid Information 5 10 Connecting the Purge Tubing to the Connector Cabl
3. Selector knob 4 3 figure 4 2 Slave monitor connection 4 3 8 8 Soft buttons See also Impella System Using the system BACK 4 7 Description 4 3 4 7 figure 4 2 4 6 SPLAY 4 7 C 2 Center 2 Home 2 nfusion 2 Placement C 2 Purge C 2 Time scale 2 Y axis scale C 2 EXIT 4 7 Exit repositioning guide 4 7 figure 6 21 FLOW CONTROL 4 7 C 1 MENU 4 7 Alarm history C 3 Case start C 4 Disable Enable Audio Impella Sensor Failure Disable Enable Audio Purge Flow Low System Blocked C 3 Disable Enable placement monitoring C 3 Disable Enable P level suction control C 3 Disable Enable reverse flow control C 3 Language C 3 Log export C 3 Screen brightness C 3 Service timers Set date time C 3 Settings Service C 3 Start timed data recording C 4 Switch to P level flow mode C 3 System information C 3 Timed data recording C 3 MUTE ALARM 4 7 C 1 NEXT 4 7 P LEVEL Selecting P Level figure 5 18 PURGE SYSTEM 4 7 C 2 Change purge cassette C 2 Change purge fluid C 2 Change purge system C 2 De air purge system C 2 Transfer to standard configuration C 2 Specifications Electrical 8 3 Electromagnetic compatibility 8 5 RFID transmitter Receiver specifications 8 8 Table 201 Guidance and Manufacturer s Declaration Emissions All Equipment and Systems 8 6 Table 202 Guidance and Manufacturer s Declaration Immunity 8 6 Table 203 Guidance and Manuf
4. 5 A 2 J fe I m lt 9 r 5 gt I m E m a To select the default purge fluid values displayed on the screen scroll to and select OK This will select those values and automatically advance to the next screen b To change the purge fluid information scroll to the appropriate item and push the selector knob to select it Then scroll through the values and push the selector knob to make a new selection Refer to Entering Purge Fluid Data in the Case Start discussion at the beginning of this section for a listing of purge fluid dextrose concentration and heparin concentration options The controller will use the default values if no other selections are made CHANGE PURGE FLUID Purge Solution Bottles These are the steps you will follow to change only the purge fluid If the purge solution is 1 supplied in bottles open the vent on the purge fluid 2 spike and follow the same procedure as if supplied in bags 3 4 5 6 7 Flushing Purge Cassette Fluid It may be helpful to flush the 8 fluid from the purge cassette when you are changing dextrose concentration 9 10 Press PURGE SYSTEM and select Change Purge Fluid Select 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
5. Shaded Steps All shaded steps require sterile technique Purge Solution Bottles If the purge solution is supplied in bottles open the vent on the purge fluid spike and follow the same procedure as if supplied in bags Connect Purge Pressure Transmitter Within 10 Seconds An alarm will appear if the purge pressure transmitter is not snapped into place within 10 seconds of inserting the purge cassette Close Purge Cassette Door Once the purge cassette is installed be sure to close the purge cassette door to prevent the purge cassette from being dislodged accidentally 5 6 gt INSERT PURGE CASSETTE Open the purge cassette package Secure the red and yellow luers to the sterile field Pass the purge cassette and spike off the sterile field Spike the fluid bag bottle Open the purge cassette door by pressing the release on the left side of the controller Insert the purge cassette into the Automated Impella Controller as shown in Figure 5 4 and described in the steps that follow Impelly Comtrotter 1 Snap Purge Cassette into Compartment 2 NH Slide Purge Pressure Transmitter into Slot Until It Snaps into Place 3 Extend Purge Tubing and Close Purge Cassette Door Figure 5 4 Inserting Purge Cassette into Automated Impella Controller 6 The purge cassette snaps into a molded compartment on the front of the controller Follow the diagram on the inside
6. m 2 2 Z Purge System Blocked 75 45 second delay PATIENT ENVIRONMENT The Automated Impella Controller and the components of the Impella System are approved for use within the patient environment defined in IEC 60601 1 1 and in the figure below 2 5 7 CONTROLLER 1 5m on Fd 5 CONTROLLER 1 1 1 1 I I I A 15 j kN 47 Figure 8 1 Automated Impella Controller Patient Environment Impella 2 5 Catheter with the Automated Impella Controller 8 9 WHITE CONNECTOR CABLE Length 2 5m Service life Single use only IMPELLA CATHETER PARAMETERS Impella 2 5 Speed range 0 to 51 000 rpm Power consumption Less than 0 99 A Voltage Max 20 V DC Flow Maximum 2 5 L min Purging the Impella Catheter Recommended purge fluid 20 dextrose solution with heparin concentration of 50 IU per mL Dextrose concentration 5 to 40 Purge pressure 300 to 1100 mmHg Infusion rate 2 to 30 mL h Maximum duration of use US 6 hours Catheter dimensions Length of invasive portion without catheter 130 3 mm Latex Free Diameter Max 4 2 mm nom 4 0 mm Classification per Protection class II degree of protection DIN EN 60601 1 CF Automated Impella Controller and Impella European Directive 93 42 EEC Catheter Classification per Class Ill MDD 93 42
7. Solution Solution in Pressure Bag U Automated Impella Controller v Q Impella Catheter SABIOMED 1 H E Connector Cable E Purge Cassette 3 a Cam u gt o gt EO Gros Y Connector ams Figure 5 24 Standard Configuration for Impella System after Transfer from the Set up Configuration PURGE CASSETTE PROCEDURES within 2 minutes The Impella Catheter may be damaged if replacement takes longer than 2 minutes When replacing the purge cassette the replacement process must be completed There are five procedures for maintaining the Impella Catheter purge system e Change purge system changing cassette and purge fluid e Change purge fluid e Change purge cassette e De air purge system e Transfer to standard configuration Each procedure can be accessed using the PURGE SYSTEM soft button Transferring to the standard configuration was discussed above The other four purge cassette procedures are discussed below Instructions for Use amp Clinical Reference Manual US CHANGE PURGE SYSTEM Follow these steps to change both the purge cassette and purge fluid 1 Press PURGE SYSTEM and select Change Purge System from the menu 2 Open the purge cassette package If the system is in the standard configuration disconnect the Y connector from the purge cassette tubing as shown in Figure 5 25 Figure 5 25 Disconnecting the Y Connector from the Purge Cassette Tubing Spik
8. APPENDIX AUTOMATED IMPELLA CONTROLLER MENU STRUCTURE OVERVIEW The soft buttons on the Automated Impella Controller provide access to the controller menu structure The menu structure has 5 main elements e MUTE ALARM e FLOW CONTROL e DISPLAY e PURGE SYSTEM e MENU This Appendix provides an overview of the Automated Impella Controller menu structure Many of the functions accessed through this menu structure are also discussed elsewhere in this manual MUTE ALARM The MUTE ALARM soft button 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 alarms are active no bell icon is displayed When you press MUTE ALARM it acknowledges all active alarms and silences the audible alarm indicator for 2 minutes for red or yellow alarms or 5 minutes for white alarms Refer to section 7 of this manual for more information about Automated Impella Controller alarms FLOW CONTROL The FLOW CONTROL soft button opens the FLOW CONTROL menu enabling you to choose ON or AUTO mode It also opens the FLOW CONTROL meter enabling you to select the desired flow rate The FLOW CONTROL menu and the FLOW CONTROL meter are shown in Figures 5 20 and 5 21 in this manual and the procedure for setting flow rate is described in Positioning and Starting the Impella Catheter in section 5
9. figure 5 13 5 14 Warranty See Warranty Weaning 5 28 Rapid weaning 5 28 Slow weaning 5 28 Indications 2 1 Infusion history screen See Controller Infusion history screen Introducer kit Components 0 035 inch stiff guidewire 3 9 10 cc syringe 3 9 18 G Seldinger needle 3 9 Dilator 3 9 figure 3 9 Peel away introducer 3 9 See also Peel away introducer figure 5 12 5 20 Description 3 9 figure 3 9 Introducers Alternative qualified introducer sheaths 5 1 B 1 L Language C 3 Latex See Patient management Latex M Magnetic navigation systems 5 6 25 Maintenance and repair See Impella System Maintenance and repair Motor housing See Catheter Catheter components Motor housing N NaCl solution See Sodium chloride IV flush solution in pressure bag P Patient management ECG interference 6 4 Echocardiography for positioning catheter 6 4 INDEX Electromagnetic fields 6 24 Electromagnetic mapping EAM systems 6 24 Magnetic navigation systems MNS 6 25 Emergency shutdown procedure 6 28 General patient care considerations 6 1 Hemolysis 6 17 Guide for managing hemolysis 6 18 nfusion history 4 11 figure 4 12 Latex 6 4 Operating the Impella Catheter without heparin 6 19 See also Heparin Overview 6 1 Placement signal lumen Description 6 22 Flush solution change out procedure 6 22 figure 6 23 Recommended standards for maintenance of the plac
10. particularly when the mapping catheter is close to the Impella Catheter motor For example mapping in the right or left ventricular outflow tracts places the mapping catheter in close proximity to the Impella Catheter motor in the ascending aorta Electromagnetic interference may appear as e Instability in the displayed location of the mapping catheter e Magnetic interference errors generated by the electroanatomic mapping system If you suspect interference follow the troubleshooting steps in Table 6 3 Table 6 3 Troubleshooting When Operating the Impella Catheter in the Presence of an EAM System Observation Actions Interference with the 1 Check for and address other sources of interference magnetic location detection 2 Reposition the Impella Catheter slightly to move the motor away component of the EAM from the mapping catheter Do NOT pull the inlet area out of the system left ventricle 3 Reduce the flow rate motor speed of the Impella Catheter Instructions for Use amp Clinical Reference Manual US MAGNETIC NAVIGATION SYSTEMS MNS Example of MNS When initiating Impella Catheter support in the presence of a magnetic navigation system MNS follow the steps below oo Magnetic Navigation System 1 Insert the Impella Catheter following the steps outlined in section 5 of this manual Stereotaxis 2 Place the MNS magnets in the Reduced or Stowed position 3 Start the Impella Cat
11. 4 6 HOME SCREEN The home screen displays operating parameters and information for the entire Impella System Figure 4 3 illustrates the home screen Each element of the display is described in Table 4 3 Catheter System Date Serial Number and Time 1 Confirm Impella position with imaging 2 Follow repositioning guide if needed Alarm 1 Check left side filling and volume status 2 Check Impella position Window 3 Reduce flow or performance level 1 The purge flow has increased by 2 5 mL hr or more Purge Flow Increased 2 This is a notification only no action is required FLOW CONTROL Soft Central 1 gt DISPLAY Button Display Labels Area PURGE SYSTEM Impella Flow Purge System _ System Power 2 3 Min 1 5 Limin Purge Flow 20 0 ml hr Flow Area Purge System Area System Power Area Figure 4 3 Home Screen Table 4 3 Automated Impella Controller Display Elements Display Element Description Alarm window The alarm window displays up to 3 alarms simultaneously in order of priority from top to bottom For each alarm the alarm window displays e Alarm header displayed in the left column window is color coded red for critical alarms yellow for serious alarms white for advisory notifications gray for resolved alarms e Alarm subhead if applicable further describes the alarm condition e Detailed text up to 3 lines of instructions for resolving
12. G 2 2 a I m G gt Jg 9 5 A 2 fe m m J E I m lt v m r E 5 gt I m E m PATIENT WEANING 1 Weaning the patient from the Impella Catheter is at the discretion of the physician The following weaning protocols are provided as guidance only RAPID WEANING Initiate rapid weaning by decreasing catheter flow rate by 0 5 L min or decreasing P level in 2 level steps at intervals of several minutes Do NOT decrease flow rate below 0 5 L min P2 until just before removing the catheter from the ventricle 2 When flow rate has been reduced to 1 0 L min P2 maintain the patient at 1 0 L min for at least 10 minutes before discontinuing circulatory support 3 If the patient s hemodynamics remain stable follow instructions in the next section for removing the Impella Catheter SLOW WEANING 1 Initiate slow weaning by decreasing catheter flow rate by 0 5 L min or decreasing P level in 2 level steps at intervals over time as cardiac function allows Do NOT decrease flow rate below 0 5 L min P2 until just before removing the catheter from the ventricle 2 When flow rate has been reduced to 1 0 L min P2 maintain the patient at 1 0 L min until the patient s hemodynamics remain stable before discontinuing circulatory support 3 If the patient s hemodynamics remain stable follow instructions the next section for
13. Impella 2 5 Catheter with the Automated Impella Controller Ca gt U m 2 9 x DISPLAY The DISPLAY soft button opens a menu that includes the following options for viewing waveforms and navigating to other screen displays e Y axis Scale opens a menu from which you can select a waveform and change its appearance by adjusting the scale of the y axis Once the waveform is selected turn the selector knob clockwise to increase the y axis scale and counterclockwise to decrease the y axis scale Select OK to accept the new y axis scale Select Restore to return to the default y axis scale Select Initial to set the y axis to the previously set scale Select Center Signal to center the waveform Select Cancel to exit the tool e Time Scale allows you to apply different time scales to the currently displayed waveforms e Center automatically centers the motor current waveform and adjusts the range accordingly e Infusion opens the Infusion History screen The Infusion History screen which is discussed in section 4 of this manual shows the volume and amount of heparin and dextrose delivered The top entry in the table shows the volume and amount of heparin and dextrose infused from the top of the hour through the current time e Purge displays the purge system waveforms and pressure and flow values e Placement opens the placement signal motor current placement s
14. Instructions for Use amp Clinical Reference Manual US 3 Do not stress the connector cable from the controller to the Impella Catheter Such tension could move the catheter out of correct position and compromise patient circulatory support Carefully monitor purge pressures during changes in altitude The Automated Impella Controller should be positioned to allow easy access to the display screen and soft buttons to view alarms and make any necessary changes 6 Maintain ACTs between 160 and 180 or at the level recommended by the physician responsible for the patient For more information about transport considerations refer to Patient Transport with the Automated Impella Controller User Manual FAA ADVISORY The Automated Impella Controller has been subjected to and 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 not however meet the requirements for conducted emissions of RTCA DO 160G section 21 4 and has not been tested for radiated emissions per RTCA DO 160G section 21 5 Abiomed recommends that air transport carriers follow the guidance FAA Advisory Circular AC No 91 21 1B Section 8 a of FAA Advisory Circular AC No 91 21 1B states Equipment tested and found to exceed the section 21 Category M emission levels are required to be evaluated in th
15. Repositioning Guide The repositioning guide can also be used for correcting Impella Catheter positioning Impella Flow 4 Purge System al System Power 2 7 Max L 3dHm 5 2 3 Min L min Purge Flow 10 0 ml hr 100 Figure 6 6 Impella Catheter Fully in Ventricle Actions to take 1 Under fluoroscopic or echocardiographic guidance if available reduce the flow rate to 1 L min and carefully pull back the Impella Catheter until the aortic waveform signal is showing 2 When you see the aortic waveform signal pull the catheter back an additional 4 cm Impella 2 5 Catheter with the Automated Impella Controller 6 13 IMPELLA CATHETER COMPLETELY IN THE AORTA or INLET AND OUTLET AREAS IN VENTRICLE AND OPEN PRESSURE AREA IN AORTA If the Impella Catheter is completely in the aorta or if the inlet and outlet areas are in the ventricle and the open pressure area is in the aorta the following alarm will appear Impella Position Wrong In this situation the placement screen will appear as shown in Figure 6 7 Impella 2 5 S N 123456 1 Confirm Impella positioi 2 Follow repositioning gui FLOW __ CONTROL DISPLAY PURGE __ SYSTEM Impella Flow 4 Purge System _ System Power 2 7 Max IE 9 O 2 5 Min L min Purge Flow 10 0 ml hr 100 Figure 6 7 Impella Catheter Completely in the Aorta or Inlet and Outlet Areas in Ventricle and Open Pressure Area in Aorta A
16. System Hertz Enclosure of the Impella Catheter motor Central delivery unit of the Impella Catheter consisting of the motor motor housing cannula with inlet and outlet and pigtail at the tip Pressure present in the Impella Catheter and in the infusion line Impella purge cassette used for rinsing the Impella Catheter Reverse flow through the cannula when the Impella Catheter is at a standstill eg regurgitation Volt Volt ampere Watt Caution consult instructions for use Defibrillator proof type CF equipment Keep dry Storage temperature eg 10 C to 30 C Declares conformity with directive 93 42 EEC for medical devices Date of manufacture eg February 2009 Impella 2 5 Catheter with the Automated Impella Controller 8 1 8 m 2 m 2 gt lt m 2 T 2 2 Protect from sunlight Symbol for lot designation the manufacturer s lot designation must be stated after the LOT symbol REF 123456 Abiomed part number eg part number 123456 SN 123456 Manufacturer s serial number eg serial number 123456 Non Sterile The product is not sterile 2012 06 Use by date eg use before June 2012 Do not reuse Sterilized using ethylene oxide Electric scrap must be disposed of separately Must not be disposed of as domestic waste yl 8 Protective Earth ON OFF Alternating current AC only Equipotentiality 9 Fus
17. removing the Impella Catheter Instructions for Use amp Clinical Reference Manual US REMOVING THE IMPELLA CATHETER The Impella Catheter can be removed after weaning when the introducer is still in place or Remove the Impella when the catheter is secured with the repositioning sheath Catheter With Care REMOVING THE IMPELLA WITH THE INTRODUCER IN PLACE Removal of the Impella Catheter must be completed 1 Wean the patient by following the steps in the previous section for rapid or slow with care to avoid damage to weaning the catheter assembly 2 When the patient s hemodynamics remain stable decrease flow rate to 0 5 L min pull the catheter into the aorta and stop the motor by reducing the flow rate to 0 L min Remove the Impella Catheter through the introducer Wait until ACT drops below 150 When ACT is below 150 remove the introducer p o m Disconnect the connector cable from the Automated Impella Controller and turn the controller off by pressing the power switch on the side of the controller for 3 seconds 7 Apply manual compression for 40 minutes or per hospital protocol REMOVING THE IMPELLA SECURED WITH THE REPOSITIONING SHEATH 1 Wean the patient by following the steps in the previous section for rapid or slow weaning 2 Leave the Impella Catheter in the ventricle at a flow rate of 1 0 L min until ACT drops below 150 OR Reduce the flow rate to 0 5 L min pull the catheter into the
18. Impella Catheter electronics Controller has detected that the Impella Catheter is in the wrong position with the outlet area too close to the aortic valve Suction is detected Controller detects placement signal pulsatility is low and speed and motor current are high for more than 5 consecutive minutes Battery temperature is greater than 50 C and less than or equal to 60 C Actual flow is below the user set flow rate in AUTO Actual flow is above the user set flow rate in AUTO Flow to Impella Catheter outlet area obstructed There is a problem with the Impella Catheter sensor signal 7 5 gt c 3 m 3 9 gt e 2 E 2 m a gt rm gt 2 3 7 6 Severity Alarm Header Battery Level Low Battery Comm Failure Purge Cassette Failure Purge Volume Critically Low Impella Flow Reduced Impella Flow High Purge Volume Low Purge Flow Increased Advisory Alarms Purge Flow Decreased Impella Position Unknown Impella Position Unknown Table 7 2 Automated Impella Controller Alarm Messages continued Action Plug controller into AC power Plug controller into AC power Replace purge cassette Open the PURGE SYSTEM menu and select Change Purge Fluid Follow the instructions to change the purge fluid Check Impella position Check left side filling and volume status Reduce flow s
19. Impella Position Wrong Suction Placement Signal Lumen Blocked Battery Temperature High Impella Flow Low Impella Flow High Impella Outflow Blocked Impella Sensor Failure Table 7 2 Automated Impella Controller Alarm Messages continued Action 1 Follow the steps on the screen or 2 Exit the procedure Switch to backup controller Do not use Impella Replace Impella Confirm Impella position with imaging 2 Pull Impella back 2 cm 3 Follow repositioning guide if needed Check left side filling and volume status 2 Check Impella position 3 Reduce flow or performance level Placement and Suction Monitoring is Suspended Aspirate with syringe then flush Check controller for blocked air vents Switch to backup controller Check for suction Check for high afterload pressure Unable to achieve set flow rate Check for low afterload 1 Confirm Impella position with imaging 2 Pull Impella back 2 cm 3 Follow repositioning guide if needed Placement monitoring is suspended 1 Monitor patient hemodynamics 2 Monitor Impella position with imaging Impella 2 5 Catheter with the Automated Impella Controller Cause User has 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 There is a problem with the
20. L min or higher Place the MNS magnets in the Navigate position and proceed with magnetic navigation MNS magnets Navigate The Impella Catheter displayed flow will be artificially Displayed flow seems too high elevated when the MNS magnets are in the Navigate or position MNS magnets Stowed Displayed flow drops The displayed flow will be accurate when the MNS magnets are in the Stowed position Impella 2 5 Catheter with the Automated Impella Controller 6 25 Change Purge Fluid to Obtain Accurate Purge Values To get accurate purge values after changing to a backup controller perform the Change Purge Fluid procedure described in section 5 of this manual and replace the purge fluid bag Questions or Concerns Contact the local Abiomed team or call the 24 hour clinical support line at 1 800 422 8666 TRANSFERRING FROM THE AUTOMATED IMPELLA CONTROLLER TO A NEW AUTOMATED IMPELLA CONTROLLER TRANSFER STEPS A backup Automated Impella Controller should be available at all times when a patient is on support In the event that the controller fails follow the steps below to transition the Impella Catheter to the backup controller 1 Confirm that the backup controller is powered on and ready 2 Press PURGE SYSTEM on the original controller select Change Purge Fluid and complete the procedure to bolus the purge system Do NOT flush the purge fluid from the cassette 3
21. NOT block the cooling vents of the Automated Impella Controller while it is operating Do NOT kink or clamp the Impella Catheter or the peel away introducer During case start make sure the yellow luer connection between the purge tubing and Y connector is tightened and not leaking The Li lon 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 the Automated Impella Controller will operate for at least 60 minutes after the batteries have been fully charged Minimize exposure of Impella System components to sources of electromagnetic interference EMI Exposure to sources of EMI such as cell phones and two way radios may cause operational interference To clear interference either increase the distance between system components and the EMI source or turn off the EMI source Impella 2 5 Catheter with the Automated Impella Controller 13 gt 2 2 a wn gt 2 a gt 2 2 Operation of Impella System components may interfere with the operation of other devices If interference occurs increase the distance between the device and system components Have a backup Automated Impella Controller purge cassette connector cable and Impella Catheter available in the unlikely event of a device failure Do NOT use the bed mount as a handle Do NOT alter the Impell
22. Prime the Placement Signal Lumen 15 When the system detects that the flush solution has reached the target pressure within the required amount of time the system will advance to the next screen automatically 16 The first step on the next screen prompts you to confirm that fluid is exiting the Impella Catheter see Figure 5 11 Impella 2 5 Catheter with the Automated Impella Controller 5 9 e 2 2 m gt 5 m Jg 9 m 5 A 2 2 fe e m I m 9 r Fr 5 gt I m E m 2 ENTER PURGE FLUID DATA 1 After confirming that fluid is exiting the Impella Catheter enter the purge fluid information The screen in Figure 5 11 shows a table of recommended default values for the purge fluid Impella 2 5 S N 123456 30 06 2011 05 30 Catheter is Ready To Insert 1 Confirm fluid exiting catheter 2 Enterthe purge fluid information and select OK Purge Fluid Volume Dextrose Concentration Impella Flow 4 Purge System _ System Power 0 0 Max 0 0 0 0 Min 1 L min Figure 5 11 Entering Purge Fluid Information Ta Purge Flow 16 3 ml hr 100 2 To select the default values displayed on the screen scroll to OK below the table and press the selector knob This will select those values and automatically advance to the next screen 3 To change the purge fluid information scroll to the appropriate item and push the
23. Z E 3 4 IMPELLA CATHETER The Impella Catheter is an intravascular microaxial blood pump that delivers up to 2 5 liters of blood per minute from the left ventricle into the aorta Figure 3 4 illustrates the Impella Catheter Table 3 2 describes each component from the pigtail at one end to the check valve on the other end Catheter Shaft N Red Pressure Sidearm Pigtail Inlet Area Radiopaque Marker Outlet EasyGuide Ares Lumen Cannula Motor Housing Open Pressure Area Check Valve Pressure Reservoir Clear Sidearm Repositioning Unit Red Impella Plug Infusion Filter Figure 3 4 Impella Catheter Table 3 2 Impella Catheter Components Component Pigtail Inlet area Radiopaque marker Cannula Outlet area EasyGuide lumen Description The 6 Fr pigtail is attached to the cannula at the distal end of the inlet area It assists with stabilizing the catheter in the correct position in the left ventricle The inlet area located at the distal tip of the cannula has four openings windows that allow blood to be drawn into the inlet and channeled through the cannula The radiopaque marker on the catheter shaft is visible with fluoroscopy and when properly positioned appears at the level of the aortic valve annulus The cannula 12 Fr for the Impella 2 5 has a spiral shaped reinforced body that is shaped in
24. and apply manual pressure above the puncture site 3 Grasp the two wings and bend back until the valve assembly comes apart Continue to peel the two wings until the introducer is completely separated from the catheter shaft see Figure 5 23 Addition of Heparin to the Purge Solution As soon as practical after catheter placement change the purge fluid to include heparin The recommended heparin concentration is 50 IU mL in 20 dextrose solution Follow the Change Purge Fluid procedure 7 SCHO 5 Place two deadend caps on the stopcock to prevent further usage The sideport should to change the purge fluid not be used to give medication or draw blood because the blood could potentially 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 control the amount of fluid administered to the patient Figure 5 23 Removing the Peel Away Introducer Attach a stopcock and flush the repositioning sheath prior to advancing the sheath 6 Slide the repositioning sheath over the catheter shaft and advance it into the artery to the blue suture pads 5 20 Instructions for Use amp Clinical Reference Manual US 7 Secure the repositioning unit to the patient with the blue suture pads or a StatLock stabilization device 8 Attach the anticontamination sleeve to the blue section of th
25. can hold up to 24 hours of real time data Once memory is full the controller starts overwriting the old data The timed data recording feature allows you to permanently save real time operating data for later analysis Timed data recording is automatically turned on during certain alarm conditions to capture data for analysis You can also manually turn on the feature at any time to capture data for later analysis To manually access the timed data recording feature 1 Press MENU and scroll to Start Timed Data Recording Press the selector knob 2 The controller records data for a predefined period of 10 minutes Impella 2 5 Catheter with the Automated Impella Controller m 2 lt gt 2 gt 2 m lt 2 22 Examples of EAM Systems CARTO 3 System and CARTO XP Navigation System Biosense Webster Inc OPERATING THE IMPELLA CATHETER IN ELECTROMAGNETIC FIELDS The Impella Catheter contains a permanent magnet motor that emits an electromagnetic field This field may produce electromagnetic interference with other equipment In addition other equipment that emits a strong electromagnetic field may affect the operation of the Impella Catheter motor ELECTROANATOMIC MAPPING EAM SYSTEMS The electromagnetic field emitted by the Impella Catheter may produce interference with the magnetic location detection component of the electroanatomic mapping EAM system
26. controller automatically proceeds to the next screen Clamp the supply line before removing the purge fluid bag Replace the purge fluid bag and unclamp the supply line Select OK to complete bag change and start purge system again Enter the purge fluid information and select OK a To select the default purge fluid values displayed on the screen scroll to and select OK This will select those values and automatically advance to the next screen b To change the purge fluid information scroll to the appropriate item and push the selector knob to select it Then scroll through the values and push the selector knob to make a new selection Refer to Entering Purge Fluid Data in the Case Start discussion at the beginning of this section for a listing of purge fluid dextrose concentration and heparin concentration options The controller will use the default values if no other selections are made The next screen asks whether you want to flush the fluid from the purge cassette a To proceed with the flush scroll to and select OK b To skip the flush press EXIT to complete the Change Purge Fluid procedure If you are proceeding to flush the purge fluid from the cassette select OK to deliver a bolus to the system A progress bar shows the progress of the bolus After the bolus is delivered the controller automatically proceeds to the next screen Disconnect the luer s from the Impella Catheter and select OK to flush the purge c
27. detected and the controller is running on battery power Impella 2 5 Catheter with the Automated Impella Controller 4 7 v G 2 E I m gt 9 E 5 A fe 2 20 fe m Table 4 3 Automated Impella Controller Display Elements continued Display Element Purge system area Purge System Stabilization The purge system must stabilize after case start a purge procedure or resolution of a purge alarm During this time it may take up to 3 minutes for purge system information to display on the screen Flow area Central display area 4 8 Description Information about the purge system is displayed to the right of the flow area at the bottom of the display screen Purge system marquee scrolls from left to right when purge system is Operating e Slow scrolling represents normal purge flow rate e Fast scrolling represents bolus flow rate Y connector icon e Appears above the purge system marquee when the Impella System is configured using the Y connector in the set up configuration Purge flow e Current purge flow displayed in mL hr below the purge system marquee if the purge flow is known e Not displayed when the purge system is stabilizing when there is no purge cassette or when the procedure has not yet started Information about Impella Catheter flow is displayed in the lower left corner of the display screen Max Min e Ma
28. entering the motor Y connector for Set up a Purge pressure Transmits pressure to the controller based on the purge pressure in transmitter 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 pressure The Y connector attached to algorithm to maintain the purge pressure the purge tubing is used for Purge tubing Carries purge fluid from the purge cassette to the Impella Catheter the initial set up configuration 2 Yellow luer connector Connects the purge tubing to the Y connector at case start and to the e 3 is m check valve yellow luer lock on the Impella Catheter during system Switch to the standard change u Y connector Adapter that connects the purge tubing to the sidearms of the Impella practical Catheter during case start The Y connector consist of e Yellow luer that connects to the clear sidearm Red luer that connects to the red sidearm Cap for the red luer when it is disconnected from the sidearm for transfer to the standard configuration Clamp for the purge tubing leading to the red sidearm Rectangular antibacterial air filter 3 8 Instructions for Use Clinical Reference Manual US ACCESSORIES Table 3 4 illustrates and describes the accessories used with the Impella Catheter and Automated Impella Controller Table 3 4 Impella Catheter and Automated Impella Controller Accessories Component D
29. have been tested and approved for use with the Impella System Table B 1 Alternative Guidewires Guidewire Catalog number Boston Scientific Platinum Plus ST 0 014 in 1752 H74917520 model ST 014 300 Boston Scientific V 18 Control WireTM ST 0 018 in 46 854 model V18 18 300 ALTERNATIVE QUALIFIED INTRODUCER SHEATHS Abiomed has developed and qualified an introducer kit for use with the Impella Catheter This kit was specifically designed for use with the Impella Catheter and takes into account several technical parameters such as Size of the sheath internal diameter and length Blood leakage through the hemostatic valve Force required to pass the device through the hemostatic valve The ability to replace the introducer with a longer term sheath Testing and qualification based on the above criteria has been completed Table B 2 describes alternative introducer sheaths that have been tested and approved for use with the Impella System Use this information to evaluate the performance of these alternative introducer sheaths relative to each other and to the Abiomed provided introducer Table B 2 Alternative Introducer Sheaths Manufacture Model Fr Length Catalog Number Cook Incorporated Check Flo Introducer 14 13 cm RCF 14 0 38 J Cook Incorporated Check Flo Performer 14 30 cm RCFW 14 0 38 30 J Introducer Impella 2 5 Catheter with the Automated Impella Controller B 1 gt 2
30. selector knob to select it Then scroll through the values and push the selector knob to make a new selection The controller will use the default values if no other selections are made e Purge fluid can be set to 50 mL 100 mL 250 mL 500 mL default or 1000 mL e Dextrose concentration can be set to 5 10 20 default 30 or 40 e Heparin concentration can be set to 0 5 10 12 5 15 20 25 or 50 units mL default 5 10 Instructions for Use amp Clinical Reference Manual US SECURE THE PURGE TUBING 1 To complete the setup connect the purge tubing to the white connector cable by pushing the purge tubing into the clips attached to the white connector cable as shown in Figure 5 12 Figure 5 12 Connecting the Purge Tubing to the Connector Cable IMPELLA SYSTEM SET UP CONFIGURATION Figure 5 13 illustrates the correct set up configuration of the Impella System Dextrose Solution Automated Impella Controller Impella Catheter Connector Cable Purge Cassette Lx mms Y Connector Figure 5 13 Set up Configuration of the Impella System Impella 2 5 Catheter with the Automated Impella Controller e Z 2 m gt gt Jg 9 5 A Z J fe I m 9 r Fr 5 gt I m E m Use Fluoroscopy for Placement Impella Catheter performance will be compromised if correct placement ca
31. the connector cable from the controller to the Impella Catheter 7 Impella 2 5 Catheter with the Automated Impella Controller 6 1 6 2 TRANSPORT BETWEEN HOSPITALS During transport the Automated Impella Controller may be exposed to stronger electromagnetic disturbance than during in hospital use Strong electromagnetic disturbance may cause the Automated Impella Controller to display soft button menu selections that were not selected by the user Operators should be aware that under these conditions the operating parameters are not affected No user intervention is required Monitor Impella 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 disturbance GUIDELINES FOR PATIENT TRANSPORT The Automated Impella Controller and Impella Catheter have been cleared by the FDA for hospital to hospital transport via ambulance helicopter or fixed wing aircraft The Automated Impella Controller is qualified for safe use by healthcare professionals to facilitate the transport of patients supported by the Impella System from one medical facility to another The Impella System performs life sustaining functions To use the system during transport you must understand and follow the instructions in this manual The transport team should include person s fully trained in the use of the Automated Impella C
32. to Haneling Repostdoning positioning after the patient is moved from the operating room or catheterization laboratory ida 1 Remove slack in the Impella Catheter by increasing flow rate to 2 5 L min and OA align the catheter against the lesser curvature of the aorta rather than the greater COME EL eS MCT curvature properly following insertion discuss with the care team Use fluoroscopy to verify that the slack has been removed who will resolve repositioning Verify that the Impella Catheter inlet area is optimally positioned 3 5 cm below the issues that may arise and how aortic valve they will resolve the issues eg portable fluoroscopy Return to previous flow rate echocardiography Secure the Impella Catheter at a firm external fixation point in the groin area UNDERSTANDING AND MANAGING IMPELLA CATHETER POSITION ALARMS The Automated Impella Controller continuously monitors the catheter based on the placement signal and the motor current e Placement signal 5 the signal characteristic of aortic or ventricular pressure e Motor current s the signal pulsatile or flattened If the system alarms with one of the positioning alarms described in this section fluoroscopic imaging is the best method for confirming position You can also use TEE TTE or a standard chest x ray If the Impella Catheter is either partly just the pigtail or completely in the ventricle reposition the catheter under imag
33. transport when activated clotting time ACT is less than 150 seconds Do NOT use saline in the purge system Do NOT use an Impella System if any part of the system is damaged To prevent the risk of explosion do NOT operate the Impella System near flammable anesthetics If at any time during the course of support with the Impella Catheter the Automated Impella Controller alarms Purge Pressure Low or Purge System Open follow the instructions presented in section 5 of this manual Do NOT subject a patient who has been implanted with Impella Catheter to magnetic resonance imaging MRI The strong magnetic energy produced by an MRI machine may cause the Impella System components to stop working and result in injuries to the patient An MRI may also damage the electronics of the Impella System Cardiopulmonary support CPR should be initiated immediately per hospital protocol if indicated for any patient supported by the Impella Catheter When initiating CPR reduce the Impella Catheter flow rate When cardiac function has been restored return flow rate to the previous level and assess placement signals on the controller Impella 2 5 Catheter with the Automated Impella Controller 1 1 gt 2 2 a gt 2 a gt 2 During defibrillation do NOT touch the Impella Catheter cables or Automated Impella Controller Power the Automated Impella Controller using i
34. 11 figure 3 3 5 11 Single use components 3 2 Standard configuration figure 3 3 5 22 Storage 8 13 Symbols 8 1 System configurations 3 3 Using the system See also index entries for individual system components Case start 5 5 figure 5 5 Change purge cassette 5 25 Change purge fluid 5 24 Change purge system 5 23 Connecting the catheter 5 7 Connecting the connector cable 5 7 figure 5 7 Connecting the luer s 5 8 Connecting the purge pressure transmitter 5 6 De air the purge system 5 25 Entering purge fluid data 5 10 igure 5 10 rting the catheter 5 12 igure 5 12 5 13 5 15 nserting the purge cassette 5 6 i t i nse gure 5 6 Positioning and starting the catheter 5 17 gure 5 15 5 18 Post insertion positioning PIP checklist 6 11 Preparing the catheter figure 5 7 Priming the Impella Catheter purge lumen figure 5 8 Priming the placement signal lumen 5 9 figure 5 9 Priming the purge cassette 5 6 figure 5 5 Purge system troubleshooting 5 26 Securing the purge tubing 5 11 Selecting performance level 5 19 Selecting target flow figure 5 17 5 18 Startup 5 2 Startup screen 5 4 Supplies needed 5 2 Transferring to standard configuration 5 21 Turning on the Automated Impella Controller 5 3 Using repositioning sheath and peel away introducer figure 5 20 Using the System Axillary insertion technique D 1 Inserting the catheter wired technique
35. 2 Alarm history screen 7 2 C 3 Alarm levels 7 1 Alarm messages 7 3 Alarm window 4 6 figure 7 2 itical red alarms Description 7 1 essages actions and causes 7 3 Handling alarms 7 3 High purge pressure 5 27 See also Alarms Purge low low Low purge pressure 5 26 Mute alarm function 7 2 Mute alarm indicator 4 7 figure 7 2 Overview 7 1 Purge flow low 5 27 See also Alarms High purge pressure Serious yellow alarms Description 7 1 Messages actions and causes 7 3 Understanding and managing position alarms 6 11 See also Patient management Understanding and managing Impella Catheter position alarms Anchoring ring See Catheter Catheter components Repositioning unit Anticontamination sleeve See Catheter Catheter components Repositioning unit Automated Impella Controller See Controller Automated Impella Controller cart See Controller cart C B Battery switch 4 2 5 3 Catheter Catheter components Cannula 3 4 figure 3 4 Catheter shaft 3 5 Electrical cable 3 5 figure 3 4 Pressure measurement lumen 3 5 Purge lumen 3 5 Check valve 3 5 figure 3 4 Clear sidearm 3 5 figure 3 4 EasyGuide lumen 3 4 figure 3 4 Infusion filter 3 5 figure 3 4 Inlet area 3 4 figure 3 4 Motor housing 3 5 8 1 figure 3 4 INDEX Open pressure area 3 5 figure 3 4 Outlet area 3 4 figure 3 4 Pigtail 3 4 figure 3 4 Pressure reservoir
36. 2 Storing the Automated Impella Controller sss 8 13 Returning an Impella Catheter to Abiomed United States 8 13 APPENDICES Appendix Impella System Limited Service Warranty United States A Appendix B Abiomed Approved Guidewires and Introducers B 1 Appendix C Automated Impella Controller Menu Structure E Appendix D Axillary Insertion Technique D 1 FIGURES igure 3 1 Figure 3 2 igure 3 3 igure 3 4 Figure 3 5 igure 3 6 Figure 3 7 igure 3 8 igure 3 9 igure 3 10 igure 3 11 Figure 4 1 igure 4 2 Figure 4 3 igure 4 4 Figure 4 5 igure 4 6 Figure 5 1 igure 5 2 igure 5 3 Figure 5 4 igure 5 5 Figure 5 6 igure 5 7 Figure 5 8 igure 5 9 Figure 5 10 igure 5 11 igure 5 12 igure 5 13 igure 5 14 igure 5 15 igure 5 16 igure 5 17 igure 5 18 igure 5 19 igure 5 20 igure 5 21 igure 5 22 igure 5 23 igure 5 24 igure 5 25 TABLE OF CONTENTS mpella Catheter in the 3 1 Set up Configuration of the Automated Impella Controller mpella Catheter and 0 3 3 Standard Configuration of the Automated Impella Controller Impella Catheter and Accessories 3 3 mpella
37. 2 Instructions for Use amp Clinical Reference Manual US STORING THE AUTOMATED IMPELLA CONTROLLER 8 The Li lon 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 the Automated Impella Controller will operate for at least 60 minutes after the batteries have been fully charged To keep the Automated Impella Controller battery charged the controller should e Place the Automated Impella Controller on a horizontal surface to prevent falling be plugged into an AC outlet e Connect the AC power cord to an AC outlet When plugged into an AC outlet the controller battery will charge whether the controller is on or off Storing the Controller e The battery may be destroyed if the Automated Impella Controller is stored with a depleted battery 9 m Z m gt lt m lt 2 2 lt Z RETURNING AN IMPELLA CATHETER ABIOMED UNITED STATES To return an Impella Catheter to Abiomed contact your local Clinical Consultant for an Abiomed approved return kit The kit includes instructions for returning the Impella Catheter to Abiomed Only available in the United States Impella 2 5 Catheter with the Automated Impella Controller 8 13 APPENDICES APPENDIX A IMPELLA SYSTEM LIMITED SERVICE WARRANTY UNITED r
38. 3 5 figure 3 4 Radiopaque marker 3 4 figure 3 4 Red Impella plug 3 5 figure 3 4 emory 3 5 Placement signal lumen 3 5 Pressure transducer 3 5 Red pressure sidearm 3 5 figure 3 4 5 9 Repositioning unit 3 5 5 19 figure 3 4 Connecting the catheter 5 7 Description 3 4 figure 3 4 Dimensions 8 11 figure 8 11 Parameters 8 10 Position alarms See Patient management Understanding and managing Impella Catheter position alarms Returning an Impella Catheter to Abiomed US 8 13 Using the catheter See also Impella System Using the system Axillary insertion technique D 1 nserting the catheter wired technique 5 12 5 15 figure 5 12 5 13 5 15 nserting the catheter wireless technique 5 16 Loading the catheter on the placement guidewire with EasyGuide lumen 5 13 figure 5 13 Loading the catheter on the placement guidewire without EasyGuide lumen 5 14 igure 5 14 Positioning and starting the catheter 5 17 igure 5 15 5 18 Post insertion positioning PIP checklist 6 11 Preparing the catheter 5 12 figure 5 7 Using repositioning sheath and peel away ntroducer 5 19 figure 5 20 Catheter operation icon 4 8 Catheter serial number Definition 4 6 8 1 figure 4 6 Cautions 1 3 Connector cable Connecting the connector cable 5 7 figure 5 7 Description 3 9 figure 3 9 Specifications 8 10 Contraindications 2 1 Controller AC fuses 4 5 figur
39. Controller is connected back to AC power the white advisory notification turns gray and the AC power icon turns green Instructions for Use amp Clinical Reference Manual US 5 USING THE AUTOMATED IMPELLA CONTROLLER WITH THE IMPELLA CATHETER PRE SUPPORT EVALUATION 5 1 Alternative Sheaths and Surgical 51 STARTUP cocaina 5 2 Supplies Needed socorrer 5 2 Turning On the Automated Impella 5 3 Ne Startup Screen nennen 5 4 CASE STAR Toc iio Case Start Insert Purge Cassette 5 6 Connect the Impella Catheter sss 5 7 Enter Purge Fluid Data sts 5 10 Secure the Purge TUBING en ee 5 11 Impella System Set up Configuration sss 5 11 INSERTING THE IMPELLA CATHETER WIRED INSERTION 5 12 WIRELESS INSERTION OF THE IMPELLA 2 5 5 16 uu 5 16 Wireless Insertion Technique 5 16 Recommendations for Handling the Impella 2 5 5 16 POSITIONING AND STARTING THE IMPELLA
40. Disconnect the yellow luer connector from the Impella Catheter to release the pressure in the purge cassette 4 Transfer the purge cassette and purge solution from the original controller to the backup controller Reconnect the yellow luer connector to the Impella Catheter Remove the white connector cable from the original controller and plug it into the catheter plug on the front of the backup controller 7 the Impella Catheter is connected to the backup controller a message will appear on the screen asking you to confirm re starting the Impella Catheter at the previously set flow rate 8 Press OK within 10 seconds to confirm restarting the Impella Catheter at the previously set flow rate PATIENT MANAGEMENT CHECKLIST FOLLOWING TRANSFER OF SUPPORT After transferring patient support to or from the Automated Impella Controller perform each of the following patient management checklist items 1 Confirm Impella Catheter placement using echocardiography 2 Tighten the Tuohy Borst valve tighten all the way to the right on the Impella Catheter to prevent catheter migration 3 For patients supported with the Impella 2 5 Catheter attach a saline pressure bag pressurized to 350 mmHg to the red sidearm and complete the Transfer to Standard Configuration procedure under the PURGE SYSTEM menu Instructions for Use amp Clinical Reference Manual US TRANSFERRING FROM THE AUTOMATED IMPELLA CONT
41. E ESKE SEEE E ERES TESS ERES ENES EREEREER EETA 5 5 nserting the Impella Catheter Wired 1 5 12 Wireless Insertion of the Impella 2 5 5 16 Positioning and Starting the Impella 5 17 TO 5 19 Use of the Repositioning Sheath and the Peel Away Introducer Transfer to Standard Configuration sss 5 21 P rgeiCassetteProcedures una 5 22 Troubleshooting the Purge System coccion 5 26 Patient Weaning c csccesececeseeseseseeeeseeeeseeeeeaeeseesesneneesesseseseeeeaseseeeeseees 5 28 Removing theilmpella Catheter ncaa aaa 5 29 6 PATIENT MANAGEMENT TOPICS Patient Management Overview mee eee 6 1 General Patient Care Considerations 2 22 6 1 Transport Within the Hospital seen 6 1 Transport Between Hospitals sss 6 2 Right Heart leia 6 3 ECONS caia 6 4 o iian 6 4 Use of Echocardiography for Positioning of the Impella Catheter 6 4 Understanding and Managing Impella Catheter Position Alarms 6 11 UA A PTET 6 17 MO ee 6 17 Operating the Impella Catheter without Heparin in the Purge Solution 6 19 Repositioning Gulden 6 19 Placement Signal Lumen sss 6 22 Timed Data RECOMING O 6 23 Operating the Impella Catheter in El
42. EEC Latex free Yes The Automated Impella Controller and Impella Catheter including all accessories are latex free 8 10 Instructions for Use amp Clinical Reference Manual US IMPELLA 2 5 CATHETER DIMENSIONS Point of Insertion 93 cm min to 99 cm max Maximum interventional length II IT ZZ Eur 11 Repositioning 45 5 cm sheath Length of 116 min to 122 cm max sterile sleeve Figure 8 2 Impella 2 5 Catheter Dimensions Impella 2 5 Catheter with the Automated Impella Controller 8 11 8 9 Z m gt lt m 2 2 Z ANATOMIC CONSIDERATIONS In a small number of cases about 2 in every 100 patients the Impella Catheter cannot be successfully placed or can be placed and the performance is compromised due to patients having anatomic conditions outside of the range for which the Impella Catheter was designed The following table describes anatomic conditions that may affect the insertion or operation of the Impella Catheter Physicians should consider these characteristics when evaluating small or very tall patients for Impella Catheter support Condition Effect The size and tortuosity of the Limits the ability of the Impella Catheter to be advanced from femoral and iliac arteries the insertion site into the left ventricle Dist
43. EPOSITIONING GUIDE Abiomed strongly recommends using fluoroscopy to guide placement and positioning of the Impella Catheter However if fluoroscopy or other imaging guidance is not available you can use the repositioning guide to correct the position of the catheter across the aortic valve The repositioning guide provides information about the current position of the catheter and the actions required to reposition it To use the repositioning guide 1 Press MENU and scroll to Start Repositioning Guide Press the selector knob to initiate the repositioning guide algorithm Follow the instructions in the instructional display area under the headline Reposition Guide Active Impella 2 5 Catheter with the Automated Impella Controller Start Repositioning Guide The repositioning guide is an option on the MENU only if the controller has triggered a wrong or unknown Impella Catheter position or a catheter outlet blocked alarm 6 19 2 gt 2 gt 2 m 2 ES A u Wait for New Flow Level After you press OK to decrease the flow rate the system displays a message instructing you to walt until the new flow rate is reached before advancing the catheter Yellow Flow Rate If the Automated Impella Controller detects incorrect or unknown catheter position or if placement monitoring is suspended the flow rate in the flow area appears in yellow as shown in Figur
44. HE AUTOMATED IMPELLA CONTROLLER TO A NEW AUTOMATED IMPELLA 6 26 6 26 Patient Management Checklist following Transfer of 6 26 TRANSFERRING FROM THE AUTOMATED IMPELLA CONTROLLER TO AN IMPELLA S CONSOLE 6 27 TRANSFERRING FROM AN IMPELLA CONSOLE TO THE AUTOMATED IMPELLA CONTROLLER een 6 28 EMERGENCY SHUTDOWN PROCEDURE 6 28 PATIENT MANAGEMENT OVERVIEW The information and instructions in this section of the manual are not intended to supersede established medical procedures concerning patient care Best practice as determined by the medical community should always be observed In each case the clinician must determine whether the application of information provided is appropriate for the particular clinical setting GENERAL PATIENT CARE CONSIDERATIONS e Do not raise the head of the bed to higher than a 30 degree angle e Use knee immobilizer as needed to maintain access site straight m 2 gt 2 gt 2 m 2 22 u e Perform dressing changes per hospital protocol using aseptic technique e Assess access site for bleeding and hematoma e Be careful not to pull on the Impella Catheter when transferring a patient from one bed to another e To prevent the purge tubing
45. Impella 2 5 with the Automated Impella Controller Circulatory Support System INSTRUCTIONS FOR USE amp CLINICAL REFERENCE MANUAL United States only OO OABIOMED Recovering hearts Saving lives IMPORTANT NOTICE Read this entire manual before using the Automated Impella Controller and Impella 2 5 Circulatory Support System Impella 2 5 System The Impella 2 5 System is to be used only in accordance with this manual This manual is only applicable to Impella systems using the Automated Impella Controller Information contained in this document is subject to change without notice 2013 Abiomedf Inc All rights reserved The ABIOMED logo and ABIOMED are registered trademarks of Abiomed Inc in the U S A and certain foreign countries Recovering hearts Saving lives is a trademark of Abiomed Inc Impella is a registered trademark of Abiomed Europe GmbH a wholly owned subsidiary of Abiomed Inc in the U S A and certain foreign countries IMPELLA 2 5 WITH THE AUTOMATED IMPELLA CONTROLLER INSTRUCTIONS FOR USE amp CLINICAL REFERENCE MANUAL UNITED STATES ONLY Rx Only Abiomed Inc 22 Cherry Hill 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 com email www abiomed com 24 Hour Emergency Hotlines N Ameri
46. Impella 2 5 Catheter product number 004672 OVERVIEW Physicians should exercise special care when inserting the Impella Catheter in patients with known or suspected unrepaired abdominal aortic aneurysm or significant descending thoracic aortic aneurysm or dissection of the ascending transverse or descending aorta Physicians have developed a wireless technique as an alternative to the standard insertion method for the Impella 2 5 Catheter This technique eliminates several of the steps in the traditional insertion method WIRELESS INSERTION TECHNIQUE 1 Place a 13 Fr introducer in the usual manner Administer heparin When the ACT is above 250 seconds remove the 13 Fr dilator Straighten the pigtail at the end of the Impella 2 5 Catheter by hand and advance it through the hemostatic valve Advance the catheter in small steps to avoid kinking 4 Track the catheter through the descending aorta using fluoroscopy Maintain the pigtail curve on the medial aspect of the aorta closer to the spine 5 When the pigtail reaches the aortic valve rest the pigtail against the medial cusp and continue to advance it until the catheter begins to prolapse 6 Pull back while turning the catheter clockwise allowing it to advance pop across the aortic valve 7 If the catheter fails to advance across the valve pull back twist 45 and repeat the process RECOMMENDATIONS FOR HANDLING THE IMPELLA 2 5 CATHETER During wire
47. Impella Catheter Components 3 4 Purge Cassette Components 3 8 Impella Catheter and Automated Impella Controller ACCESSORIES E 3 9 Automated Impella Controller Front View Features 443 Automated Impella Controller Side View Features 4 5 Automated Impella Controller Display Elements 4 6 Evaluation Prior to Inserting the Impella Catheter 5 1 Performance Level Flow 5 19 Guide for Managing Hemolysis in Various Circumstances 6 18 Recommended Standards for Maintenance of the Placement Malasia 6 22 Troubleshooting When Operating the Impella Catheter in the Presence of an EAM 6 24 Troubleshooting When Operating the Impella Catheter in the Presence of a MNS 6 25 Alarm bevels Snn sayin 71 Automated Impella Controller Alarm Messages 73 Alternative B 1 Alternative Introducer 2 B 1 INTRODUCTION PURPOSE OF MANUAL This Instructions for Use amp Clinical Reference Manual is designed for healthcare professionals It contains clinical and technical information to guide healthcare professionals in their use of the Impella 2 5 Catheter with the Automa
48. Impella 2 5 Catheter with the Automated Impella Controller vu m 2 gt 2 gt 2 m m 2 22 u IMPELLA CATHETER OUTLET AREA ON OR NEAR AORTIC VALVE If the Impella Catheter outlet area is on or near the aortic valve the catheter may be too deep in the ventricle The following alarm will appear Impella Position Wrong In this situation the placement screen will appear as shown in Figure 6 9 1 Confirm Impella position ng 2 Follow repositioning guide if needed FLOW __ CONTROL SYSTEM Impella Flow 4 Purge System _ System Power 2 7 Max mm 2 5 Min L min Purge Flow 8 0 ml hr 100 Figure 6 9 Impella Catheter Outlet Area on or near Aortic Valve Actions to take 1 Assess and adjust Impella Catheter position under fluoroscopic or echocardiographic guidance if available 2 If fluoroscopic or echocardiographic guidance is not available reduce the flow rate to 1 L min and gently pull the catheter back 2 cm to see if the condition resolves 6 16 Instructions for Use amp Clinical Reference Manual US SUCTION Suction may occur if the blood volume available for the Impella Catheter is inadequate or restricted Suction limits the amount of support that the Impella Catheter can provide to the patient and results in a decrease in arterial pressure and cardiac output It can damage blood cells leading to hemolysis It may also be an i
49. Insertion site infection e Myocardial infarction e Perforation e Renal failure e Respiratory dysfunction e Sepsis e Thrombocytopenia e Thrombotic vascular non CNS complication e Transient ischemic attack TIA e Vascular injury e Ventricular fibrillation e Ventricular tachycardia Instructions for Use Clinical Reference Manual US 3 THE IMPELLA CATHETER AND AUTOMATED IMPELLA CONTROLLER OVERVIEW 3 1 Reusable System Components 3 2 SinglesuseSystemiCormponents icti ttr 3 2 Impella Set up and Insertion Kit tns 3 2 System ConfigUratiofis aan 3 3 IMPELEA CATHETER tonta ce three bas 3 4 AUTOMATED IMPELLA CONTROLLER eene 3 6 PURGE CASSETTE voii eden anke nennen 3 7 Digi il 3 9 OO 00 OVERVIEW The Impella Catheter is an intravascular microaxial blood pump that supports a patient s circulatory system The Impella Catheter is inserted percutaneously through the femoral artery and into the left ventricle see Figure 3 1 To T Figure 3 1 Impella Catheter in the Heart When properly positioned the Impella Catheter delivers blood from the inlet area which sits inside the left ventricle through the cannula to the outlet opening in the ascending aorta Phy
50. LIES NEEDED In addition to the supplies used for femoral artery insertion of the Impella Catheter you will also need the following for axillary insertion e 8 or 10 mmx 20 cm vascular graft 6 or 8 Fr sheath OVERVIEW OF SURGICAL TECHNIQUE FOR AXILLARY INSERTION 1 8 9 Expose the axillary artery and wrap vessel loops distal and proximal to the point of incision Make an incision between the loops and attach an 8 or 10 mm vascular graft Attach a standard 6 or 8 Fr sheath to the end of the graft to control bleeding Insert the diagnostic catheter over a diagnostic guidewire into the left ventricle Remove the diagnostic guidewire and exchange it for the supplied 0 018 inch placement guidewire Remove the 6 or 8 Fr sheath Backload the Impella Catheter over the guidewire and insert the catheter into the vessel advancing it along the placement guidewire into the left ventricle Remove the guidewire Cut the graft and advance the repositioning sheath into the remaining end of the graft 10 Secure the sheath and close the incision site Impella 2 5 Catheter with the Automated Impella Controller 1 gt 9 0 m 2 9 x o A Activated clotting time ACT ACT for catheter insertion with Ilb Illa inhibitor 5 12 Adverse events potential 2 2 Alarms Advisory white alarms Description 7 1 Messages actions and causes 7 3 Alarm delay information 8 9 Alarm display 7
51. ONS 8 3 EQUIPMENT DESIGN rrr curre teet e csi 8 4 EQUIPMENT 5 8 4 FEDERAL COMMUNICATIONS COMMISSION FCC NOTICE 8 5 ELECTROMAGNETIC COMPATIBILITY eene 8 5 SLAVE MONITOR CONNECTION 8 8 ALARM DELAY 1 8 9 PATIENT ENVIRONMENT ciconia heroum 8 9 WHITE CONNECTOR CABLE etre tente 8 10 IMPELLA CATHETER PARAMETERS 200222411 8 10 IMPELLA 2 5 CATHETER DIMENSIONS eene 8 11 ANATOMIC CONSIDERATIONS eese 8 12 CLEANING 8 12 STORING THE AUTOMATED IMPELLA 8 13 RETURNING AN IMPELLA CATHETER TO ABIOMED UNITED STATES asis 8 13 TERMINOLOGY ABBREVIATIONS AND SYMBOLS TERMINOLOGY AND ABBREVIATIONS Catheter serial number Dextrose and Glucose Hz Motor housing or pump housing Pump Purge pressure Purge system Retrograde flow VA SYMBOLS Identification number of the Impella Catheter stated on the package label on the red Impella plug and the Automated Impella Controller display screen The terms dextrose and glucose are used interchangeably to refer to the solution used as purge fluid for the Impella
52. Placement Monitoring Disabled in yellow when you turn off placement monitoring through the menu Instructions for Use amp Clinical Reference Manual US PLACEMENT SCREEN 14 The placement screen see Figure 4 4 displays real time operating data for the system The screen displays the placement signal and motor current waveforms as well as the maximum minimum and average values for each waveform in the central display area of the screen Use the DISPLAY soft button to navigate to the placement screen FLOW __ CONTROL Waveforms in Central Display Area SYSTEM 2 2 I m gt gt m m 5 A 2 2 m Impella Flow Purge System System Power 2 7 Max y CC 0 2 3 Min 2 5 L min Purge Flow 20 0 ml hr 100 Figure 4 4 Placement Screen Retrograde Flow Figure 4 4 shows two time based waveform signals from different sources e Placement signal waveform A setting of O L min PO will result in retrograde flow when the Impella Catheter is placed across the aortic valve Retrograde flow may also occur at 0 5 L min 1 e Motor current waveform PLACEMENT SIGNAL WAVEFORM The placement signal waveform displays a pressure measurement that is useful for determining the location of the open pressure area of the catheter with respect to the aortic valve The placement signal is used to verify the position of the micro
53. ROLLER TO AN IMPELLA CONSOLE If a patient must be transferred from the Automated Impella Controller to an Impella Console follow the steps below 1 Gather the following items prior to transferring support e Impella Console system Console infusion pump and Impella Power Supply on cart e Blue connector cable e Gray pressure transducer cable e Infusion pump tubing e CM Set e Purge solution recommended 20 dextrose with 50 IU mL of heparin Turn on the Impella Console Set up the infusion pump and tubing Connect the gray pressure transducer cable to the CM Set and the Impella Console Plug the blue connector cable into the Impella Console Press PURGE SYSTEM on the Automated Impella Controller select Change Purge Fluid and complete the procedure to bolus the purge system Do NOT flush the purge fluid from the cassette Do m mew Disconnect the purge cassette tubing Purge System Open alarm will sound Connect the new purge tubing and start the infusion Disconnect the white connector cable from the Impella9 Catheter 10 Connect the blue connector cable to the Impella Catheter 11 Once the Impella Catheter is connected to the console a message will appear on the screen asking you to confirm re starting the Impella Catheter at the previously set flow rate 12 Press OK within 10 seconds to confirm restarting the Impella9 Catheter at the previously set flow rate After transferring pat
54. TE There may be purge alarms on the Impella Console Continue with the purge fluid change and check the alarms once the transfer has been completed 11 Complete the purge fluid change making sure to flush the purge tubing 12 Disconnect the old purge tubing 13 Connect new purge tubing After transferring patient support to the Automated Impella Controller perform the patient management checklist items described earlier in Transferring from an Automated Impella Controller to a New Automated Impella Controller EMERGENCY SHUTDOWN PROCEDURE In the unlikely event that the Automated Impella Controller software stops responding follow the procedure below to restart the controller without stopping the Impella Catheter Press and hold the power switch for 30 seconds An Emergency Shutdown Imminent alarm will sound at 15 seconds 1 2 3 The controller will shut down after 30 seconds 4 Restart the controller 6 28 Instructions for Use amp Clinical Reference Manual US 7 AUTOMATED IMPELLA CONTROLLER ALARMS ALARMS OVERVIEW s ie eher tet c 74 EE ee 71 Alarm Display inno tome 72 FUNCION iic tritt 7 2 ALARM MESSAGE SUMMARY ccrte eee i a 7 3 OO 00 ALARMS OVERVIEW The Automated Impella Controller monitors various functions to determine whether specific operational parameter
55. a Introducer kit in any way Aspiration and saline flushing of the Impella Introducer kit sheath dilator and valve should be performed to help minimize the potential for air embolism and clot formation Indwelling introducer sheaths should be internally supported by a catheter or dilator Dilators and catheters should be removed slowly from the sheath Rapid removal may damage the valve resulting in blood flow through the valve Never advance the guidewire or sheath when resistance is met Determine the cause of resistance using fluoroscopy and take remedial action When injecting or aspirating through the sheath use the sideport only A A A A A A A A 2 1 4 Instructions for Use amp Clinical Reference Manual US 2 INDICATIONS CONTRAINDICATIONS AND POTENTIAL ADVERSE EVENTS INDICATIONS UNITED 5 5 002 2 1 CONTRAINDICATIONS UNITED STATES eene 2 1 POTENTIAL ADVERSE EVENTS UNITED STATES 2 2 INDICATIONS UNITED STATES The Impella 2 5 Circulatory Support System is intended for partial circulatory support using an extracorporeal bypass control unit for periods up to 6 hours It is also intended to be used to provide partial circulatory support for periods up to 6 hours during procedures not requiring cardiopulmonary bypass The Impella 2 5 Circulatory Support System also provides
56. a 45 degree angle The cannula is made of nitinol and covered in polyurethane The proximal end of the cannula is attached to the outlet area where the blood exits the cannula The red loading lumen which runs from the tip of the pigtail through the outlet area of the cannula facilitates loading the catheter onto the guidewire Instructions for Use amp Clinical Reference Manual US Table 3 2 Impella Catheter Components continued Component Description Motor housing The motor housing 12 Fr for the Impella 2 5 consists of an encapsulated motor Open pressure area The open pressure area is an opening located between the motor housing and the distal end of the catheter shaft Catheter shaft A 9 Fr catheter shaft is located between the motor housing and the red Impella plug The lumen of the catheter shaft contains a purge lumen a pressure measurement lumen and an electrical cable The catheter shaft has longitudinal and transversal marks e The longitudinal mark along the inner radius shows correct position of the 0 018 inch 260 cm placement guidewire once backloaded on the Impella Catheter e The transversal marks at 1 cm intervals with numbers every 5 cm aid in proper positioning Repositioning unit The repositioning unit consists of a sheath an anticontamination sleeve with an anchoring ring and suture pads e The sheath with hemostatic valve is graduated from 9 Fr to 13 Fr It is located on the cathete
57. a fluid filled pressure lumen with an inlet at the proximal end of the motor housing and the pressure sensor located in the red Impella plug The Automated Impella Controller software monitors both the pressure waveform characteristics and motor current to determine the placement of the Impella Catheter inlet and outlet areas relative to the aortic valve Table 6 2 provides recommended standards for maintaining the placement signal Table 6 2 Recommended Standards for Maintenance of the Placement Signal Heparin in the flush solution Frequency of line and flush solution change out Periodic flushing of the placement signal lumen Note Either of these actions may result in sensor or position alarms Pressure bag inflation pressure Abiomed suggests that the hospital follow its own established protocol for using heparin in the flush solution Abiomed suggests that the hospital follow its own established protocol for time interval for change of the flush solution Slight dampening If you observe a dampened placement signal pinch the white flush valve located on the red sidearm for a few seconds to restore the placement signal quality Severe or lost pressure 1 Close the roller clamp and disconnect the IV tubing connected to the red pressure sidearm Connect a syringe of saline to the port and squeeze the white flow valve as you draw negative pressure Continue aspiration of the port until blood is visua
58. acturer s Declaration Emissions Equipment and Systems that are Life Supporting 8 7 Table 205 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Impella amp Controller Equipment and Systems that are Life Supporting 8 8 D INDEX Equipment classification 8 4 Equipment design 8 4 Mechanical 8 3 Patient environment 8 9 figure 8 9 Startup screen 5 4 figure 5 4 Storage 8 13 Transferring from an Impella Console to the Automated Impella Controller 6 28 Transferring from the Automated Impella Controller to a new Automated Impella Controller 6 26 Patient management checklist following transfer of support 6 26 Transferring from the Automated Impella Controller to an Impella Console 6 27 USB connector 4 5 figure 4 4 VGA RS 232 jack 4 5 figure 4 4 Controller cart 3 10 figure 3 10 D Dextrose solution Description 3 10 8 1 figure 3 3 3 10 Heparin 3 10 Infusion history 4 11 Purge fluid recommendation 8 10 Purge solution bottles 5 6 5 24 Setting dextrose concentration 5 10 Diagnostic catheters AL1 5 2 5 13 Multipurpose MP 5 2 5 13 Pigtail 5 13 E ECG interference See Patient management ECG interference Echocardiography Color Doppler 6 10 figure 6 10 Transesophageal TEE 6 4 figure 6 5 6 8 Transthoracic TTE 6 4 figure 6 5 6 9 6 10 Electroanatomic mapping EAM systems 6 24 F FAA Tr
59. ance Consider giving volume additional volume will expand the end systolic ventricular volume e Reduce PA pressure Improve right heart function Note on imaging All imaging technology represents the anatomy in two dimensions 2D It is not possible to assess the interactions between the catheter and the intraventricular anatomy that occur in three dimensions 3D Abiomed strongly recommends that the catheter be repositioned even if the imaging view shows correct position 6 18 Instructions for Use amp Clinical Reference Manual US OPERATING THE IMPELLA CATHETER WITHOUT HEPARIN IN THE PURGE SOLUTION The Impella Catheter is designed to be operated with a purge solution that contains heparin Operation of the system without heparin in the purge solution has not been tested In the event that a patient is intolerant to heparin due to heparin induced thrombocytopenia HIT or bleeding physicians should use their clinical judgment to assess the risks versus benefits of operating the Impella System without heparin If it is in the best interest of the patient to operate the system without heparin the dextrose solution is still required and physicians should consider systemic delivery of an alternative anticoagulant DO NOT add any alternative anticoagulant such as a direct thrombin inhibitor to the purge fluid The Impella Catheter has not been tested with any alternative anticoagulants in the purge solution R
60. ance from the insertion site For very tall patients the maximum interventional length may to the apex of the left ventricle not be sufficient to allow correct placement of the Impella Catheter Systolic left ventricular LV long The Impella Catheter may interfere with the mitral valve axis lt 7 cm Systolic left ventricular LV long Impella Catheter pigtail will not have a surface to push axis gt 11 cm against to help stabilize its position and may have a tendency to swing or bounce CLEANING e Clean the Automated Impella Controller keypad and display with either 70 isopropyl Alcohol Warning alcohol or soap and water NOTE Be aware that soft buttons may be activated when you spray or wipe the display Do NOT clean the Impella e Clean the Automated Impella Controller housing with mild detergent Catheter infusion filter or pressure reservoir with e Do NOT clean with or expose any part of the clear sidearm of the Impella Catheter eg alcohol and AVOID exposing infusion filter pressure reservoir to alcohol Alcohol has been shown to cause cracks and these components to leaks in these components Carefully read labels on common skin preps and lotions to products containing alcohol avoid using any alcohol containing products in the area of the infusion filter or pressure reservoir e Do NOT allow any fluids to enter the connector sockets Clean the connector cable with 70 isopropyl alcohol 8 1
61. ansport Advisory 6 3 Fluoroscopy Use in Impella Catheter placement 5 12 6 4 G Glucose solution 8 1 See also Dextrose solution GP Ilb Illa inhibitors 5 12 Guidewires See also Impella System Using the system Inserting the catheter 0 018 inch 260 cm placement guidewire 3 9 figure 3 9 Abiomed approved guidewires B 1 H Hemolysis See Patient management Hemolysis Heparin Adding heparin to purge solution 5 20 Heparin in flush solution 6 22 Infusion history 4 11 Operating the Impella Catheter without heparin 6 19 Purge fluid recommendation 8 10 Setting heparin concentration 5 10 Home screen See Controller Home screen Impella Catheter See Catheter Impella Controller See Controller Impella Set up and Insertion kit 3 2 Impella System Accessories 3 9 Anatomic considerations 8 12 Cleaning 8 12 Cleaning the connector cable 8 12 Cleaning the controller 8 12 Components See also Catheter See also Purge cassette figure 3 3 Controller menu structure C 1 General system information 8 12 Modes of operation 5 18 5 19 FLOW CONTROL AUTO 5 17 5 19 BOOST 5 18 ON 5 17 5 19 P LEVEL 5 19 Overview 3 1 figure 3 1 3 3 3 6 Pre support evaluation 5 1 Removing the Impella Catheter 5 29 Removing with the introducer in place 5 29 Removing with the repositioning sheath 5 29 Returning an Impella Catheter to Abiomed United States 8 13 Reusable components 3 2 Set up configuration 5
62. aorta approximately 30 to 40 cm and wait until ACT drops below 150 When ACT is below 150 reduce flow rate to O L min Remove the Impella Catheter and repositioning sheath together the catheter will not come through the repositioning sheath 2 2 a I m gt m Jg 9 5 A 2 2 m m J I m 9 r Fr 5 gt I m E m 5 Disconnect the connector cable from the Automated Impella Controller and turn the controller off by pressing the power switch on the side of the controller for 3 seconds 6 Apply manual compression for 40 minutes or per hospital protocol Impella 2 5 Catheter with the Automated Impella Controller 5 29 6 PATIENT MANAGEMENT TOPICS PATIENT MANAGEMENT OVERVIEW eere 6 1 GENERAL PATIENT CARE CONSIDERATIONS 6 1 TRANSPORT WITHIN THE HOSPITAL eee 6 1 TRANSPORT BETWEEN HOSPITALS essecessesseesseeeseeeteeeaseeseeseeeteeeateeees 6 2 Guidelines for Patient Transport 6 2 Important Transport Considerations sss 6 2 ye t 6 3 RIGHT HEART FAILURE 2220 ee 6 3 IDE 6 4 LATEX cosacos 6 4 USE ECHOCARDIOGRAPHY FOR POSITIONING OF THE IMPEELA CATHETER 6 4 AAA o 6 4 Correct Impella C
63. aortic valve e Catheter angled toward the left ventricular apex away from the heart wall and not curled up or blocking the mitral valve SMITH JOHN ABCDEFG SMITH JOHN 06 03 2008 11 11 34 TISO 7 MISA ABCDEFG e Catheter inlet area in aorta or near the aortic valve e Catheter pigtail in papillary muscle e Catheter pigtail too close to the mitral valve e Catheter inlet area more than 4 cm below the aortic valve or lodged between papillary muscle and the myocardial wall e Catheter outlet area too close to the aortic valve SMITH JOHN 06 03 2009 11 11 34AM TISO 7 ABCDEFG 1 39Hz a Correct Impella Catheter Position b Impella Catheter Too Far into Left Ventricle TTE e Catheter inlet area 3 5 cm below the aortic valve e Catheter inlet area more than 4 cm below the aortic valve e Catheter outlet area well above the aortic valve e Catheter outlet area across or near the aortic valve e Catheter angled toward the left ventricular apex away from the heart wall and not curled up or blocking the mitral valve SMITH JOHN CDEFG c Impella Catheter Inlet in Aorta TTE d Impella Catheter in Papillary Muscle TTE e Catheter inlet area in aorta or near the aortic valve e Catheter pigtail in papillary muscle e Catheter pigtail too dose to the mitral valve e Catheter inlet area more than 4 cm below the aortic valve or lodged between papillary muscle and the myocardial wall e Catheter outlet area too close
64. ar assist device VAD support Patient conditions including catheter position pre existing medical conditions and small left ventricular volumes may also play a role in patient susceptibility to hemolysis Patients who develop high levels of hemolysis may show signs of decreased hemoglobin levels dark or blood colored urine and in some cases acute renal failure Plasma free hemoglobin PfHgb is the best indicator to confirm whether a patient is exposed to an unacceptable level of hemolysis Management technique may differ depending on the underlying cause of hemolysis Table 6 1 provides guidance for various circumstances Impella 2 5 Catheter with the Automated Impella Controller m 2 gt 2 gt 2 m 2 22 u Condition Impella inlet area in close proximity to intraventricular wall Wrong pump position Higher than needed flow setting Inadequate filling volume Pre existing patient conditions or other medical procedures Controller Indicators e Impella Flow Reduced or Suction alarms Lower than expected flows e Position alarms with higher than expected flows e Impella Flow Reduced or Suction alarms with lower than expected flows e Pump outlet blocked alarms There may be no controller indicators Impella Flow Reduced or Suction alarms e Position alarms e Impella Flow Reduced or Suction alarms e Lower than ex
65. ardiograms from patients supported with the Impella Catheter include e Correct Impella Catheter position e mpella Catheter too far into the left ventricle e mpella Catheter inlet in the aorta mpella Catheter in papillary muscle The following pages describe each situation Figure 6 2 illustrates a transesophageal echocardiogram TEE of each situation Figure 6 3 illustrates a transthoracic echocardiogram TTE of each CORRECT IMPELLA CATHETER POSITION For optimal positioning of the Impella Catheter the inlet area of the catheter should be 3 5 cm below the aortic valve annulus and well away from papillary muscle and subannular structures The outlet area should be well above the aortic valve If the Impella Catheter is correctly positioned echocardiography will likely show the following as depicted in Figures 6 2a TEE and 6 3a TTE e Catheter inlet area 3 5 cm below the aortic valve e Catheter outlet area well above the aortic valve frequently not visible on TEE or TTE images e Catheter angled toward the left ventricular apex away from the heart wall and not curled up or blocking the mitral valve IMPELLA CATHETER TOO FAR INTO THE LEFT VENTRICLE If the Impella9 Catheter is positioned too far into the left ventricle the patient will not receive the benefit of Impella Catheter support Blood will enter the inlet area and exit the outlet area within the ventricle Obstruction of the Im
66. as shown in Figure 5 17 The physician can focus on advancing the guidewire and if the cannula needs to be hyperextended the scrub assistant is available to assist Figure 5 17 Loading the Catheter on the Guidewire without the EasyGuide Lumen and Aligning the Placement Guidewire 11 Advance the catheter through the hemostatic valve into the femoral artery see Figure 5 18 and along the placement guidewire and across the aortic valve using a fixed wire technique Follow the catheter under fluoroscopy as it is advanced across the aortic valve positioning the inlet area of the catheter 3 5 cm below the aortic valve annulus and in the middle of the ventricular chamber free from the mitral valve chordae Be careful not to coil the guidewire in the left ventricle 5 14 Instructions for Use amp Clinical Reference Manual US Take Small Bites During Insertion While inserting the Impella Catheter push the catheter from only a few centimeters behind the hub of the peel away introducer This prevents the catheter from buckling during insertion Figure 5 18 Inserting the Impella Catheter Do NOT Touch Inlet or Outlet Areas To prevent device failure do NOT start the Impella Catheter until the guidewire While feeding the Impella has been removed Catheter through the introducer hold the catheter Do NOT remove the Impella Catheter over the length of the guidewire at the cannula or motor housing Do NOT touch the inl
67. assette A progress bar shows the progress of the flush When complete the controller proceeds to the next screen When the purge cassette flush is complete you can connect the luer s to the Impella Catheter to complete the procedure or press BACK to repeat the flush Instructions for Use amp Clinical Reference Manual US CHANGE PURGE CASSETTE Changing the Purge These are the steps you will follow to replace only the purge cassette Cassette 1 Press PURGE SYSTEM and select Change Purge Cassette The Change Purge Cassette procedure will only be 2 3 Disconnect the luer s from the Impella Catheter and remove the used purge cassette available if the Automated Impella Controller detects 4 Spike the fluid bag 5 that the cassette s defective Insert a new purge cassette into the controller Be sure to slide the purge pressure transmitter into place and extend the purge tubing through the gap in the purge cassette door when you close the door Open the purge cassette package 6 The system automatically primes the purge cassette A progress bar shows the progress of the priming Once the priming is complete you are prompted to connect the purge cassette to the Impella Catheter 7 Connect the luer s on the end of the purge tubing to the luer s on the Impella Catheter 8 When the purge cassette change is complete press OK to exit DE AIR PURGE SYSTEM These are the steps you will follow to de air
68. atheter Position 6 6 Impella Catheter Too Far into the Left Ventricle Impella Catheter Inlet in the Aorta 6 7 Impella Catheter in Papillary Muscle 021 0 6 7 Color Doppler Echocardiography sss 6 10 Post insertion Positioning PIP Checklist sse 6 11 UNDERSTANDING AND MANAGING IMPELLA CATHETER POSITION ALARMS aaa 6 11 Correct Position Impella Catheter Fully in Ventricle nennen 6 13 Impella Catheter Completely in the Aorta or Inlet and Outlet Areas In Ventricle and Open Pressure Area in Aorta 6 14 Low Native Heart Pulsatility minit ttc 6 15 Impella Catheter Outlet Area on or near Aortic 6 16 SUCIO Nous aa 6 17 HEMOLYSIS 2 nen ieu edat 6 17 OPERATING THE IMPELLA CATHETER WITHOUT HEPARIN IN THE PURGE SOLUTION cierto teneor 6 19 REPOSITIONING GUIDE ea 6 19 PLACEMENT SIGNAL LUMEN esent nennen nnne 6 22 Background zu 6 22 Flush Solution Change Out Procedure sess 6 22 TIMED DATA RECORDING cierto iii 6 23 OPERATING THE IMPELLA CATHETER IN ELECTROMAGNETIC FIELDS 6 24 Electroanatomic Mapping EAM Systems nennen 6 24 Magnetic Navigation Systems 5 1 1 00 6 25 TRANSFERRING FROM T
69. atheter across the aortic valve The controller can be powered by AC power or can operate on internal battery power for at least 60 minutes when fully charged This section of the manual discusses Automated Impella Controller features and displays Impella 2 5 Catheter with the Automated Impella Controller 4 1 v G 2 E I gt gt lt 9 m 5 A fe 2 J fe m Es AUTOMATED IMPELLA CONTROLLER FEATURES IMPORTANT NOTE The underside of the Automated Impella Controller has a battery switch to turn on the batteries This switch is turned off for shipping purposes Before 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 battery power Figure 4 1 illustrates the features on the front of the Automated Impella Controller These features are described in Table 4 1 Display Screen SOFT BUTTONS MUTE ALARM FLOW CONTROL Power Indicator er f DISPLAY Selector Knob Ja PURGE SYSTEM n MENU Purge Pressure Transmitter Catheter Plug Purge Cassette Purge Cassette Door open Figure 4 1 Automated Impella Controller Features Front View Instructions for Use Clinical Reference Manual US Table 4 1 Automated Impella Controller Front View Featur
70. axial blood pump by evaluating the current pressure waveform as an aortic or ventricular waveform The scale for the placement signal waveform is displayed to the left of the waveform The default scaling is 0 160 mmHg It can be adjusted in 20 mmHg increments with a minimum upper limit of 100 mmHg and a maximum upper limit of 240 mmHg for the Impella Catheter To the right of the waveform is a display that labels the waveform provides the units of measurement and shows the maximum and minimum values and the average value from the samples received At the bottom of that window is the time scale which you can set by pressing the DISPLAY soft button Impella 2 5 Catheter with the Automated Impella Controller 4 9 MOTOR CURRENT WAVEFORM Motor current is a measure of the energy intake of the Impella Catheter motor The energy intake varies with motor speed and the pressure difference between the inlet and outlet areas of the cannula Motor current see Figure 4 4 provides information about the catheter position relative to the aortic valve When the Impella Catheter is positioned correctly with the inlet area in the ventricle and the outlet area in the aorta the motor current is pulsatile because the pressure difference between the inlet and outlet areas changes with the cardiac cycle When the inlet and outlet areas are on the same side of the aortic valve the motor current will be dampened or flat because there is little or no press
71. ca 1 800 422 8666 Europe 49 0 1805 2246633 August 2013 Document No 0042 9000 Rev G OO OABIOMED Recovering hearts Saving lives TABLE OF CONTENTS INTRODUCTION 1 WARNINGS AND CAUTIONS Wi MSc 1 1 EO E 1 3 2 INDICATIONS CONTRAINDICATIONS AND POTENTIAL ADVERSE EVENTS Indications United 5 2 Contraindications United States 2 1 Potential Adverse Events United 51 2 2 3 THE IMPELLA CATHETER AND AUTOMATED IMPELLA CONTROLLER Ds 3 1 impellat 3 4 Automated Impella Controller 3 6 A A 3 4 3 9 4 USING THE AUTOMATED IMPELLA CONTROLLER 4 1 Automated Impella Controller 4 2 RO 4 6 Placement Screen i cct mitis 4 9 Screen esse IDEE IINE 4 10 InfustoniHistony SOCET iia 4 11 M ble Operation TO 4 12 5 USING THE AUTOMATED IMPELLA CONTROLLER WITH THE IMPELLA CATHETER A A EREE 54 MU 0 220 5 2 SYAiiirresrrrerrtres isirEiseisrisrE r S rEES r
72. catheter using the EasyGuide lumen 9 Insert the placement guidewire into the red EasyGuide lumen at the tip of the pigtail as shown in Figure 5 16 If the catheter does not have a red EasyGuide lumen follow the procedure outlined in step 10 a Advance the guidewire until it exits the red lumen near the label b Remove the EasyGuide lumen by gently pulling the label while holding the Impella Catheter as shown in Figure 5 16 c Skip to step 11 if the catheter is successfully backloaded on the guidewire Figure 5 16 Loading the Catheter on the Guidewire using the EasyGuide Lumen Impella 2 5 Catheter with the Automated Impella Controller Using a Pigtail Diagnostic Catheter with Side Holes When using a pigtail diagnostic catheter with side holes ensure that the guidewire exits the end of the catheter and not the side hole To do so magnify the area one to two times as the guidewire begins to exit the pigtail Impella Catheter Use in Open Heart Surgery If the Impella Catheter is used in the OR as part of open heart surgery manipulation may be performed only through the 9 Fr steering catheter Direct manipulation of the catheter assembly through the aorta or ventricle may result in serious damage to the Impella Catheter and serious injury to the patient Do NOT reinsert the EasyGuide lumen Once you remove the EasyGuide lumen from the Impella Catheter do not attempt to reinsert it If nec
73. ccessful placement of the Impella Catheter Use imaging technology to examine the patient s vasculature and femoral access site An echo assessment of the left ventricle is also recommended to rule out left ventricular thrombus mechanical aortic valves or severe aortic insufficiency Table 5 1 Evaluation Prior to Inserting the Impella Catheter Technology Observations e Standard traditional angiography e LV thrombus e Magnetic resonance angiography MRA Mechanical aortic valve e Coronary computed tomography e Aortic valve stenosis calcification angiography CTA Moderate to severe aortic insufficiency e Ultrasound e Tortuous iliac artery Echocardiography e Multiple access scar tissue Severe peripheral arterial obstructive disease Obesity ALTERNATIVE SHEATHS AND SURGICAL TECHNIQUES If the patient has a tortuous iliac artery an alternative 30 cm sheath can be used for insertion of the Impella Catheter The Impella Catheter can also be inserted surgically A surgical technique is described in Appendix D e 2 a gt 5 m Jg 9 5 A 2 2 fe I m 9 r Fr 5 gt I m E m Impella 2 5 Catheter with the Automated Impella Controller 5 1 STARTUP Do NOT use an Impella System if any part of the system is damaged The sterile components of the Impella System can be used only if t
74. controller beeps Priming Purge Cassette Priming Purge Lumen Impella Flow 4 Purge System System Power 0 0 Max 0 0 L min Figure 5 7 Priming the Impella Purge Lumen Purge Flow 100 11 Connect and tighten the luer s on the purge tubing to the Impella Catheter as shown in Figure 5 8 Figure 5 8 Connecting the Luer s to the Impella Catheter 12 When the controller detects that the luer s are connected it automatically begins priming the purge lumen at a bolus rate of greater than 250 mL h and tracking the progress on the second progress bar Instructions for Use amp Clinical Reference Manual US 13 Once the purge lumen is primed the controller automatically advances to the next screen Figure 5 9 Impella 2 5 S L rime Placement Prime Placement Signal Lumen Lumen an Squeeze 1 Squeeze white flush valve until controller beeps beeps Priming Impella Placement Signal Lumen Figure 5 9 Priming the Placement Signal Lumen neal Gl messem Sym Flow Purge System __ 7 SUM Power 0 0 Max COE mmn o 0 0 Min Q 0 L min Purge Flow 100 14 Prime the Impella Catheter placement signal lumen by squeezing the white flush valve for 10 seconds see Figure 5 10 until the Automated Impella Controller beeps The progress bar shows the progress of the priming MS White Flush Valve Figure 5 10 Squeezing the White Flush Valve to
75. creen described in section 4 under Placement Screen Home opens the home screen described in section 4 under Home Screen PURGE SYSTEM The PURGE SYSTEM soft button opens a menu that includes the following purge system procedure options Change Purge Fluid starts the procedure to change the purge fluid Change Purge Cassette starts the procedure to replace the purge cassette e Change Purge System starts the procedure to change both the purge fluid and purge cassette De air Purge System starts the de air procedure e Transfer to Standard Configuration starts the procedure for transferring from the set up configuration of the Impella System to the standard configuration These procedures are described in section 5 of this manual C 2 Instructions for Use Clinical Reference Manual US MENU The MENU soft button opens a menu of options related to controller settings alarm history repositioning and starting a procedure The menu includes the following options Settings Service gt U m 2 9 x Service System Information Opens the System Information table This provides information about the software version addresses current type of Impella Catheter and current catheter runtime Set Date Time Displays the menu for changing the date and time Service Timers Displays the Service Timers menu Console operating time and purge motor operating time are displaye
76. ctions to take 1 Under fluoroscopic or echocardiographic guidance determine the Impella Catheter position Reduce flow rate to 1 L min and reposition the catheter as necessary If fluoroscopic or echocardiographic imaging is not available reposition the catheter according to the repositioning guide 4 If step 3 does not provide correct positioning obtain imaging equipment fluoroscopy echocardiography or chest x ray to check the catheter position 6 14 Instructions for Use amp Clinical Reference Manual US LOW NATIVE HEART PULSATILITY When a patient has poor native ventricular function the placement signal may remain pulsatile however the amplitude will be dampened and both the minimum and maximum values will be greater than zero because the aortic valve does not open and the Impella Catheter raises the aortic blood pressure above the ventricular pressure during systole In a situation of low native heart pulsatility the Automated Impella Controller may not be able to determine the catheter position You may see the following indication on the home screen Impella Position Unknown In this situation the screen will appear as shown in Figure 6 8 FLOW CONTROL SYSTEM Impella Flow Purge System _ System Power 2 7 Max y O 2 3 Min L min Purge Flow 20 0 mi hr 100 Figure 6 8 Impella Catheter Position Unknown Actions to take 1 Assess cardiac function
77. d Impella Controller 3 9 Component Description Hospital Provided Dextrose solution typically 20 dextrose in water with 50 IU mL of heparin is used as the purge fluid through the Impella Catheter Figure 3 10 Dextrose Solution The Automated Impella Controller cart holds the Automated Impella Controller The cart has wheels for easy transport of the controller and a storage basket For more information including assembly instructions refer to the Automated Impella Controller cart instructions for use Figure 3 11 Automated Impella Controller Cart 3 10 Instructions for Use amp Clinical Reference Manual US 4 USING THE AUTOMATED IMPELLA CONTROLLER OVERVIEW 4 1 AUTOMATED IMPELLA CONTROLLER 4 2 HOME SCREEN coccion o 4 6 PLACEMENT SCREEN etre rent tero 4 9 Placement Signal Wave MW 4 9 Motor Current Waveform essen 4 10 PURGE SCREEN iii di 4 10 Purge nta 4 11 P rge PSU ici e ie ie nn 4 11 INFUSION HISTORY SCREEN cocina cat 4 11 MOBILE OPERATION oit toten tuetur nente 4 12 OO 00 OVERVIEW The Automated Impella Controller is the primary user control interface for the Impella Catheter It controls the Impella Catheter performance monitors the catheter for alarms and provides real time catheter position information regarding the location of the c
78. d for aortic insufficiency malfunction be damaged or Partial circulatory support with Impella has been associated with more extensive cease To operate Ihe yellow use of rotational atherectomy Extensive use of rotational atherectomy has been symbol A appears before associated with a periprocedural increase in cardiac biomarkers indicative of caution messages myocardial injury Rotational atherectomy with or without the use of hemodynamic support should be used in accordance with the manufacturer s instructions for use Physicians should exercise special care when inserting the Impella Catheter in patients with known or suspected unrepaired abdominal aortic aneurysm or significant descending thoracic aortic aneurysm or dissection of the ascending transverse or descending aorta Use only original accessories and replacement parts supplied by Abiomed Do NOT use damaged or contaminated connector cables To prevent device failure do NOT start the Impella Catheter until the guidewire has been removed Do NOT remove the Impella Catheter over the length of the guidewire When replacing the purge cassette the replacement process must be completed within 2 minutes The Impella Catheter may be damaged if replacement takes longer than 2 minutes To prevent malfunction of the Automated Impella Controller avoid long term exposure to direct sunlight and excessive heat 40 C To prevent overheating and improper operation do
79. d hold the power switch on the right side of the Automated Impella Controller Battery Switch for 3 seconds see Figure 5 1 Automated Impella Controller for the first time turn on the switch on the underside of the controller to turn on the batteries Power Switch on Right Side of Impella Controller Figure 5 1 Automated Impella Controller Power Switch The Automated Impella Controller 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 test fails the controller displays a system self check failure message SYSTEM SELF CHECK FAILED CHANGE CONSOLE IMMEDIATELY The controller displays the reason for the system test failure at the bottom of the screen Impella 2 5 Catheter with the Automated Impella Controller 5 3 2 2 a I m gt Jg 9 5 A 2 J fe m m J I m 0 m r rm gt gt I m E m THE STARTUP SCREEN The startup screen see Figure 5 2 appears when you successfully turn on the Automated Check Date and Time Impella Controller The current date and time appear at the top of the startup screen Confirm that these are correct Impella Controller Start up Screen New Case Press MENU or plug in new Impella catheter for case s
80. d in hours Screen Brightness Opens the Screen Brightness selection box The brightness of the screen display can be set from 50 to 100 Select OK to confirm selection Select Cancel to cancel selection Language Opens the Language selection box Use the selector knob to select German English French Italian Spanish or Dutch The system will immediately change the language on the controller for all displayed text This language will be used after system restart unless another language is selected Log Export Displays the Log Export menu for exporting all logs to a USB stick Switch to P Level Flow Mode Allows you to switch between flow and P level modes Disable Enable Placement Monitoring Disable Enable Reverse Flow Control Disable Enable P Level Suction Control Disable Enable Audio Impella Sensor Failure Allows you to enable or disable audio for the Impella Sensor Failure alarm This selection is available only if an Impella Sensor Failure alarm is active or the audio has been disabled for this alarm Disable Enable Audio Flow Low System Blocked Allows you to enable or disable audio for the Purge Flow Low or Purge System Blocked alarms This selection is only available if one of these two alarms is active or the audio has been disableted for one of these alarms e Alarm History opens the Alarm History table This provides a visual display of the chronology of stored alarm messages The mos
81. d luer on the Y connector 4 Create a slow drip from the NaCl pressure bag to flood the luer connector of the red pressure sidearm to displace any air then make the connection to the red sidearm Fully open the roller clamp The controller may alarm during this step e 2 m gt G 5 m Jg 9 r 5 A 2 2 fe E I m lt 9 r 5 gt I m E m 5 Select OK to confirm the transfer You will no longer see the set up icon on the bottom of the screen The advisory alarm message will be gray Figure 5 24 illustrates the correct configuration of the Impella System components after transitioning to the standard configuration from the set up configuration Impella 2 5 Catheter with the Automated Impella Controller 5 21 Disconnecting the Y Connector When you switch to the standard configuration you can simply disconnect cap and clamp the red luer on the Y connector as shown in Figure 5 24 or you can disconnect the Y connector entirely and connect the yellow luer on the purge tubing directly to the yellow check valve on the Impella Catheter Replacement Time If the purge flow is more than 7 mL hr or the dextrose concentration is less than 2096 replacement time will be less than 2 minutes Replacement should always be performed as quickly as possible 5 22 S Dextrose Sodium Chloride
82. dition 1 Medical Electrical Equipment Part 1 8 General Requirements for Safety Collateral Standard General Requirements Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems e EC 60601 1 6 2004 06 01 Edition 1 Medical Electrical Equipment Part 1 6 General Requirements for Safety Collateral Standard Usability EQUIPMENT CLASSIFICATIONS Type of protection against IEC 60601 1 Class degree of protection CF defibrillation proof and electric shock internally powered Relies not only on basic insulation against shock but also includes additional protection Accomplished by providing means for connecting the equipment to the protective earth conductor of the fixed wiring of the installation in a way that prevents accessible metal parts from becoming live if basic insulation fails Degree of protection against electric shock for Automated Impella Controller Mode of operation Degree of protection against explosion hazard Degree of protection against harmful ingress of water Class Equipment Continuous Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Also not suitable for use in an oxygen enriched atmosphere IEC 60529 IPX1 protected against dripping water Instructions for Use amp Clinical Reference Manual US FEDERAL COMMUNICATIONS COMMISSION FCC NOTICE This device complies with Part 15 o
83. e 5 11 Set up Configuration of the Impella System 5 11 nserting the Peel Away 5 12 nserting the Diagnostic 2 4 5 13 Loading the Catheter on the Guidewire using the EasyGuide Eh 5 13 Loading the Catheter on the Guidewire without the EasyGuide Lumen and Aligning the Placement Guidewire 5 14 nserting the Impella Catheter 5 Aortic Waveform on Placement Signal 5 5 15 FLOW CONTROL Merl 5 17 FLOW CONTROL 22 5 18 Ventricular Waveform on Placement Signal Screen 5 18 Removing the Peel Away 1 5 20 Standard Configuration for Impella System after Transfer from the Set up Configuration 5 22 Disconnecting the Y Connector from the Purge Cassette eere etre me end 5 23 F m m m mmm mm mm nnn n mn igure 6 1 igure 6 2 igure 6 3 igure 6 4 igure 6 5 igure 6 6 igure 6 7 igure 6 8 igure 6 9 igure 6 10 igure 6 11 igure 6 12 igure 6 13 igure 6 14 igure 8 1 igure 8 2 TABLES able 3 1 Table 3 2 Table 3 3 Table 3 4 Table 4 1 Table 4 2 Table 4 3 Table 5 1 Table 5 2 Table 6 1 Table 6 2 Table 6 3 Table 6 4 Table 7 1 Table 7 2 Table B 1 Table B 2 Labeled TEE and TTE Images o
84. e Non ionizing electromagnetic radiation m USB port CAT 5 Port Ethernet 8 2 Instructions for Use amp Clinical Reference Manual US AUTOMATED IMPELLA CONTROLLER MECHANICAL SPECIFICATIONS 8 Parameter Specification Temperature Operating 10 C to 40 C 50 F to 104 F Storage 15 C to 50 C 5 F to 122 F Relative Humidity Operating 95 Storage 95 Atmospheric Pressure Operating 8000 ft 750 hPa to 1000 ft 1050 hPa Storage 18 000 ft 500 hPa to 1000 ft 1050 hPa Dimensions Height 351 mm 13 8 in Width 443 mm 17 4 in Depth 236 mm 9 3 in Dimensions Height 508 mm 20 0 in Packaged Width 559 mm 22 0 in Depth 406 mm 15 0 in Weight Maximum 11 8 kg 26 1 lbs Weight Packaged Maximum 13 6 kg 30 16 Maintenance and 12 months repair interval Work must be performed by technicians authorized by Abiomed m 2 m 2 gt lt m 2 T 2 2 AUTOMATED IMPELLA CONTROLLER ELECTRICAL SPECIFICATIONS AC operation 100 230 V AC nominal 47 63 Hz 1 1 A Internal battery operation 14 4 V DC nominal lithium ion Characteristic values Max power consumption under load 120 VA 9 7 fuses 2 Amp 250 V 5 mm x 20 mm slow blow fuses Running time without AC power with fully At least 60 minutes charging duration of at least charged batteries 5 hours Electrical system Installation in accordance with pertinent regulations is
85. e 4 4 AC plug 4 5 figure 4 4 gt Alarm history screen 7 2 Alarms 7 1 Battery power 3 6 4 12 Battery switch 4 2 5 3 Bed mount 4 5 figure 4 4 Catheter plug 4 3 figure 4 2 Description 3 6 4 1 figure 3 3 3 6 4 2 4 4 Display options 4 3 See also Controller Slave monitor connection Display screen Alarm window 4 6 Catheter serial number 4 6 Central display area 4 8 Description 4 3 figure 4 2 4 4 Flow area 4 8 Mute alarm indicator 4 7 Purge system area 4 8 Soft buttons 4 7 System date and time 4 6 System power area 4 7 Emergency shutdown 6 28 Equipotential ground stud 4 5 figure 4 4 Ethernet jack 4 5 figure 4 4 Home screen Description 4 6 figure 4 6 nfusion history screen Description 4 11 figure 4 12 enu structure overview C 1 obile operation 4 12 otor current screen 4 10 figure 4 9 Placement screen Description 4 9 figure 4 9 otor current waveform 4 10 igure 4 9 Placement signal waveform 4 9 igure 4 9 Placement signal screen Aortic waveform igure 5 15 5 18 Confirming placement of Impella Catheter igure Ventricular waveform igure 5 18 Power indicator 4 3 figure 4 2 Power switch 4 5 figure 4 4 Purge cassette door 4 3 figure 4 2 Purge cassette release button 4 5 figure 4 4 Purge screen Description 4 10 igure 4 10 Purge flow 4 11 Purge pressure 4 11 A C
86. e NINE 6 20 2 Press OK to decrease flow rate as directed on the first screen of the repositioning guide Figure 6 10 The system reduces flow rate to 1 L min 30 06 2011 05 30 1 Confirm Impella position with imaging IMP Position 2 Follow repositioning guide if needed Placement FLOW Signal CONTROL mmHg 109 80 93 10 sec Reposition Guide Active Press OK to decrease flow level Impella Flow El Purge System Z System Power 2 3 Min 5 L min Purge Flow 10 0 ml hr 100 Figure 6 10 First Repositioning Guide Screen SYSTEM 3 Push the Impella Catheter forward as directed in the screen shown in Figure 6 11 until the placement signal shows ventricular pressure 5 S N 123456 30 06 2011 05 30 ar 1 Confirm Impella position with imaging Wrong 2 Follow repositioning guide if needed Placement FLOW a Signal CONTROL 87 56 67 10 sec Reposition Guide Active Push Impella forward until placement signal shows ventricular pressure Impella Flow Purge System __2 System Power EM y min Purge Flow 9 0 ml hr 100 1 2 Max 1 0 8 Min UL Figure 6 11 Second Repositioning Guide Screen Instructions for Use Clinical Reference Manual US 4 Pull the Impella Catheter back as directed in the screen shown in Figure 6 12 until the placement signal shows aortic pressure Impella 2 5 S N 123456 30 06 2011 05 30 E 1 Confirm Impella p
87. e adjusted from 20 mL hr to 200 mL hr in increments of 10 mL hr To the right of the plot is a display that labels the plot and shows the most recent value update You can set the time scale at the bottom of the window by pressing the DISPLAY soft button An advisory alarm will be displayed in the alarm window when the purge flow rate increases or decreases by 2 5 mL h The message is intended to aid patient management by alerting the clinician to changes in the rates of dextrose and heparin infusion through the purge fluid The alarm clears when you press the MUTE ALARM button PURGE PRESSURE The Automated Impella Controller regulates purge pressure the pressure of the purge fluid delivered through the catheter to the motor 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 value on this scale can be adjusted from 100 mmHg to 2000 mmHg in increments of 100 mmHg A warning appears if purge pressure falls below 300 mmHg or exceeds 1100 mmHg To the right of the plot is a display that labels the plot and shows the most recent value update You can set the time scale at the bottom of the window by pressing the DISPLAY soft button INFUSION HISTORY SCREEN The infusion history screen displays the infusion volume as well as the amount of heparin and dextrose infused each hour The current time period is d
88. e inflow may be obstructed resulting in suction alarms This positioning is also likely to place the outlet area too close to the aortic valve which can cause outflow at the level of the aortic valve with blood streaming back into the ventricle resulting in turbulent flow and hemolysis If the Impella Catheter is too close to or entangled in the papillary muscle echocardiography will likely show the following as depicted in Figures 6 2d TEE and 6 3d TTE Catheter pigtail in papillary muscle Catheter inlet area more than 4 cm below the aortic valve or lodged between papillary muscle and the myocardial wall e Catheter outlet area too close to the aortic valve The following figures depict transesophageal and transthoracic echocardiographic images of these four Impella Catheter positions Figure 6 2 shows four transesophageal depictions of Impella Catheter position and Figure 6 3 shows four transthoracic depictions of Impella Catheter position Impella 2 5 Catheter with the Automated Impella Controller 6 7 m 2 lt gt 2 gt 2 m lt 2 22 u SMITH JOHN 06 03 2009 11 11 34AM TISO 7 Mi4 4 SMITH JOHN 03 20 1 4AM 7130 7 4 4 ABCDEFG 55 1 ABCDEFG 5 80 bpm e Catheter inlet area 3 5 cm below the aortic valve e Catheter inlet area more than 4 cm below the aortic valve e Catheter outlet area well above the aortic valve e Catheter outlet area across or near the
89. e on the catheter or mechanical components at any time During case start make sure the yellow luer connection between the purge tubing and Y connector is tightened and not leaking Do NOT kink or clamp the Impella Catheter or the peel away introducer 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 The controller displays the screen shown in Figure 5 3 Prime Impella Purge Cassette 1 Insert purge cassette 2 Plug in Impella catheter cable Priming Purge Cassette System Power E Purge Flow 100 Purge System CO Figure 5 3 Initial Case Start Screen Impella 2 5 Catheter with the Automated Impella Controller Sensitive Medical Device The Impella Catheter is a sensitive medical device with extremely fine tolerances In particular the inlet and outlet areas of the catheter assembly may be damaged if subjected to strong external forces Two Ways to Start the Setup Procedure You can start the setup procedure from the MENU on the startup screen as described on this page or when a new Impella Catheter is plugged into the controller 5 5 2 2 I m gt 5 m Jg Y m m 5 A 2 2 m m I m m r gt gt m m
90. e operator s M PED selected model aircraft for electromagnetic interference EMI and radio frequency interference All navigation communication engine and flight control systems will be operating in the selected aircraft during the evaluation RIGHT HEART FAILURE The Impella Catheter is a left side support device only Patients being supported by the Impella Catheter should be monitored for signs of right heart failure Caregivers should monitor the patient closely for the following potential signs of right heart failure e Reduced output from the Impella Catheter e Suction alarms e Elevated filling pressures CVP Signs of liver failure Elevated pulmonary pressures If the patient is exhibiting signs of right heart failure the clinical team should assess the need for biventricular support Impella 2 5 Catheter with the Automated Impella Controller 6 3 m 2 gt 2 gt 2 m 2 22 u Positioning and Placement Impella Catheter performance will be compromised if correct placement cannot be confirmed While other imaging techniques such as transesophageal echocardiography TEE portable C Arm fluoroscopy or chest x ray can help confirm the position of the Impella Catheter after placement these methods do not allow visualization of the entire catheter assembly and are inadequate for reliably placing the Impella Catheter across the a
91. e position of the Impella Catheter if the Automated Impella Controller displays position alarms or if you observe lower than expected flows or signs of hemolysis If the catheter does not appear to be correctly positioned initiate steps to reposition it The illustrations on the following page identify the structures you would expect to see in transesophageal echocardiography top and transthoracic echocardiography bottom In these illustrations the Impella Catheter is positioned correctly however these depictions are stylized and in actual echocardiograms the pigtail and inlet and outlet areas may not be seen as distinctly Instructions for Use amp Clinical Reference Manual US Transesophageal Echocardiogram TEE of Impella Catheter SMITH JOHN 0 09 11 1 AM TISO 7 Mi 4 4 ABCDEFG Impella Catheter Mitral valve Ss Sen tO outlet area Location of mitral 2 chordae Papillary Aortic valve muscle Impella Catheter 80 bpm inlet area PH SMITH JOHN 06 03 2009 11 11 34AM TISO 7 M 3 4 ABCDEFG S5 1 ECHO Impella Catheter inlet area Impella Catheter outlet area Papillary y Aorta muscle Location of mitral chordae Mitral valve 80 bpm Figure 6 1 Labeled TEE and TTE Images of the Impella Catheter Position Impella 2 5 Catheter with the Automated Impella Controller 6 5 Four Impella Catheter positions you are likely to encounter when examining echoc
92. e repositioning sheath Lock the anchoring ring in place by turning it clockwise Secure the catheter shaft in place by tightening the connected anchoring ring 9 Carefully extend the anticontamination sleeve to maximum length and secure the end dosest to the red Impella plug by tightening the anchoring ring TRANSFER TO STANDARD CONFIGURATION Abiomed recommends transitioning from the initial set up configuration to the standard configuration as soon as practical After 2 hours of operation if the system is still in the set up Purge Pressure configuration a white advisory alarm notification appears on the screen instructing operators to transfer from the set up configuration to the standard configuration Either follow the instructions for completing the transfer or press Mute Alarm to mute the alarm for 30 minutes When you transfer to the standard configuration the purge pressure is no longer regulated at 600 0 To transfer to the standard configuration follow these steps In the standard configuration 1 Press PURGE SYSTEM and select Transfer to Standard Configuration from the purge flow can range from menu 2 to 30 mL hr and purge pressure can range from 300 2 Set up the sodium chloride 0 9 NaCl infusion bag with pressure bag and 96 inch to 1100 mmHg straight IV tubing 3 Disconnect the red luer on the Y connector from the red pressure sidearm on the red Impella plug Clamp and cap the re
93. e the fluid bag bottle Select 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 controller automatically proceeds to the next screen Disconnect the luer s from the Impella Catheter and remove the used purge cassette Insert the new purge cassette into the controller Be sure to slide the purge pressure transmitter into place and extend the purge tubing through the gap in the purge cassette door when you close the door 7 system automatically primes the purge cassette A progress bar shows the progress of the priming Once the priming is complete you are prompted to connect the purge tubing to the Impella Catheter 8 Connect the luer s on the end of the purge tubing to the luer s on the Impella Catheter 9 Purge system change is complete Enter the purge fluid information and select OK Impella 2 5 Catheter with the Automated Impella Controller Connecting the Purge Tubing to the Catheter If you have NOT switched to the standard configuration be sure to connect both the red and yellow luers on the Y connector to the Impella Catheter If you have switched to the standard configuration connect the yellow luer on the purge tubing directly to the yellow check valve on the Impella Catheter e 2 a m gt gt Jg 9
94. eaches AUTO confirm correct and stable placement Evaluate the catheter position in the aortic arch and remove any excess slack The catheter should align against the lesser curvature of the aorta rather than the greater curvature Verify placement with fluoroscopy and with the placement signal screen Reposition the catheter as necessary If the Impella Catheter advances too far into the left ventricle and the controller displays a ventricular waveform see Figure 5 22 rather than an aortic waveform follow these steps to reposition the catheter Pull the catheter back until an aortic waveform is present on the placement signal screen When the aortic waveform is present pull the catheter back an additional 4 cm The distance between adjacent markings on the catheter is 1 cm The catheter should now be positioned correctly FLOW CONTROL SYSTEM Impella Flow Purge System __ System Power 5 L min 2 3 Min Purge Flow 10 0 ml hr 100 MODES OF OPERATION FLOW CONTROL In AUTO the Automated Impella Controller sets the motor speed of the Impella Catheter to achieve the maximum possible flow without causing suction In Flow Control mode you can also set a target flow rate between 0 5 L min and 2 5 L min for the Impella 2 5 The controller will automatically adjust the motor speed response to changes in afterload to maintain the target flow If you select BOOST the Automated Impella Controller max
95. ectromagnetic Fields 6 24 Transferring from the Automated Impella Controller to a New Automated Impella Controller ss 6 26 Transferring from the Automated Impella Controller to an Impella onc T 6 27 Transferring from an Impella Console to the Automated Impella RR ee a re 6 28 Emergency Shutdown Procedure c cccescscsssecesseseeseeesseseseeteseeteeeeneeeenees 6 28 7 AUTOMATED IMPELLA CONTROLLER ALARMS Alanis Sra iia 7 1 Alarm Message Summary sse 7 3 8 GENERAL SYSTEM INFORMATION Terminology Abbreviations and 8 1 Automated Impella Controller Mechanical Specifications 8 3 Automated Impella Controller Electrical Specifications 8 3 Equipment 8 4 Equipment Classifications 8 4 Federal Communications Commission FCC 8 5 Electromagnetic Compatibility lt 8 5 Slave Monitor COnfie CtOM iere ee ee v ei ei e 8 8 Alarm Delay Information sse 8 9 PatienbEDVIEORITIe T 8 9 White Connector Cable seen 8 10 Impella Catheter ParaMet Sanss 8 10 Impella 2 5 Catheter 5 0000 8 11 Anatomic Considerations 8 12 CA 8 1
96. elect ON or AUTO The catheter operation icon in the lower left corner of the screen begins rotating when the Impella Catheter begins to operate a ON is the default option Press the selector knob to select ON 1 0 L min This sets the flow rate to 1 L min Then you can manually increase the flow rate to any numeric value on the flow meter as described in step 4 b AUTO automatically increases the flow rate over a period of up to 30 seconds to the maximum possible flow without causing suction To select AUTO turn the selector knob to highlight AUTO and press to select Skip to step 5 Impella 2 5 S N 123456 FLOW __ CONTROL ON 1 0 L min Impella Flow 4 Purge System __ System Power 0 0 y 0 0 Min L min Purge Flow 9 0 ml hr 100 Figure 5 20 FLOW CONTROL Menu 4 To manually increase the flow rate press the FLOW CONTROL soft button again to open the flow meter see Figure 5 21 Turn the selector knob to gradually increase flow rate to AUTO Impella 2 5 Catheter with the Automated Impella Controller 2 2 m gt 5 m Jg m 5 A 2 2 fe m m 2 m m r E 5 m m J FLOW CONTROL Impella Flow 4 Purge System __ System Power 2 3j Max 2 y Ee 2 3 Min 5 L min Purge Flow 9 0 ml hr 100 When flow rate r
97. ella Flow Purge System _ 2 7 Max System Power 2 3 Min Purge Flow 20 0 ml hr 100 Figure 7 1 Alarm Window MUTE ALARM FUNCTION Pressing the MUTE ALARM button on the upper right of the Automated Impella Controller 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 button are replaced by the mute alarm indicator a crossed out bell icon as shown in Figure 7 1 ALARM HISTORY SCREEN The alarm history screen may be accessed through the MENU This screen contains a log of the alarms that occurred during the case This log is not maintained when the Automated Impella Controller is powered down or after a power failure The controller does however maintain a long term log that is saved after the Automated Impella Controller is powered down or after a power failure and this information may be downloaded by Abiomed personnel Instructions for Use amp Clinical Reference Manual US ALARM MESSAGE SUMMARY Table 7 2 briefly describes all of the alarm messages that may appear on the Automated Impella Controller when used with the Impella 2 5 Catheter Table 7 2 Automated Impella Controller Alarm Messages Severity 19 x lt 76 pur U Alarm Header Impella Stopped Impella Stopped Controller Failure Impella Stopped Control
98. ement signal 6 22 Pre support evaluation 5 1 Repositioning guide 6 19 figure 6 20 6 21 Right heart failure 6 3 Suction 6 17 Timded data recording 6 23 Transferring from an Impella Console to the Automated Impella Controller 6 28 Transferring from the Automated Impella Controller to a new Automated Impella Controller 6 26 Patient management checklists following transfer of support 6 26 Transferring from the Automated Impella Controller to an Impella Console 6 27 Transport between hospitals 6 2 Transport within the hospital 6 1 Understanding and managing Impella Catheter position alarms 6 11 Correct catheter position 6 12 figure 6 12 mpella Catheter completely in aorta 6 14 mpella Catheter fully in ventricle 6 13 figure 6 13 mpella Catheter outlet area on or near aortic valve 6 16 figure 6 16 mpella Catheter position unknown igure 6 15 nlet and outlet areas in ventricle and open pressure area in aorta 6 14 igure 6 14 Low native heart pulsatility 6 15 Peel away introducer See also Introducer kit Components Description figure 5 12 Removing the peel away introducer 5 19 figure 5 20 Performance level Flow rates 5 19 Selecting performance level 5 19 Placement signal See Patient management Placement signal lumen Placement signal lumen 3 5 Priming the placement signal lumen 5 9 figure 5 9 Portable C Arm fluoroscopy 5 12 6 4 gt gt Post insertion
99. er 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 Impella Catheter for kinks in the tubing 2 If pressure remains high decrease the concentration of dextrose in the purge solution eg change from 20 dextrose to 10 dextrose PURGE SYSTEM BLOCKED If a Purge System Blocked alarm occurs the purge fluid flow stops 1 Check the purge system tubing and the Impella Catheter for kinks or blockages 2 Decrease the concentration of dextrose in the purge solution 3 Replace the purge cassette Impella 2 5 Catheter with the Automated Impella Controller Purge System Open Alarm This alarm may occur if purge pressure is less than 100 mmHg Unresolved High Purge Pressure Purge Flow Low Alarm If not resolved by the recommendations provided high purge pressure which triggers the Purge Flow Low alarm message could be an indication of a kink in the Impella Catheter In this case the motor is no longer being purged and may eventually stop Clinicians should monitor motor current and consider replacing the Impella Catheter whenever a rise in motor current is seen De air Procedure You may run the de air procedure described earlier in this section after changing the dextrose concentration to decrease the amount of time it takes for a change to occur
100. es Feature Display screen Soft buttons Power indicator Selector knob Purge pressure transmitter Catheter plug Purge cassette Purge cassette door Description Displays user information including the labels for the soft buttons Display screen elements described in detail later in this section Display open and close menus The function for each soft button is defined by labels adjacent to the button on the display screen function changes depending on the screen Soft button functions are described in Table 4 3 When the Impella Catheter is running the default soft button labels are as follows e MUTE ALARM FLOW CONTROL e DISPLAY e PURGE SYSTEM e MENU LED light above the selector knob indicates the power status of the Automated Impella Controller Green light controller is on and plugged into AC power or running on battery power Amber light controller is off but plugged into AC power No light controller is off and not plugged into AC power Rotating push button turn clockwise and counterclockwise to navigate through menu items push to make a selection A flexible diaphragm on the purge cassette tubing that applies pressure to the sensor in the controller so that purge pressure can be measured Connection point on the controller for the connector cable that connects to the Impella Catheter Contains the components for delivering the purge fluid maintains the pressure bar
101. escription The white connector cable connects the Impella Catheter to the Automated Impella Controller Clips on the cable are used to secure the purge tubing to the cable e The socket at the black end of the cable connects to the Impella Catheter plug e 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 7 White Connector Cable The introducer kit is used to position the Impella Catheter It contains e Peel away introducer with hemostatic valve for tight fit around components and single step break away configuration e Dilator easy to insert and remove with soft design for atraumatic approach into femoral artery 18 G Seldinger needle e 10 cc syringe e 0 035 inch stiff access guidewire E I m lt 9 gt A gt I m gt r4 Jg o gt 9 c gt o fe 2 E fe Figure 3 8 Introducer Kit The 0 018 inch 260 cm placement guidewire is used for the placement of the catheter The Guidewire Use guidewire has a radiopaque shapable tip It is important to use only the guidewire supplied with the system or an Abiomed approved alternative Refer to Appendix B for more information about Abiomed approved guidewires Figure 3 9 0 018 inch 260 cm Placement Guidewire Impella 2 5 Catheter with the Automate
102. essary follow instructions for backloading the catheter without the EasyGuide lumen 2 Z 2 Er gt gt Jg 0 r 5 Z m m I m 5 0 m gt gt m To backload the catheter without the EasyGuide lumen Men 10 Wet the cannula with sterile water and backload the catheter onto the placement guidewire One or two people can load the catheter on the guidewire During placement of the One person technique Impella Catheter take care to avoid damage to the a Advance the guidewire into the Impella Catheter and stabilize the cannula inlet area while holding the between the fingers as shown in Figure 5 17 This prevents pinching of the inlet catheter and loading the area The guidewire must exit the outlet area on the inner radius of the cannula placement guidewire and align with the straight black line on the catheter as shown in Figure 5 17 The cannula can be hyperextended as necessary to ensure the guidewire exits on the inner radius of the cannula Two person technique b The scrub assistant can help stabilize the catheter by holding the catheter proximal to the motor This will allow the implanting physician to visualize the inner radius The guidewire must exit the outlet area on the inner radius of the cannula and align with the straight black line on the catheter
103. et or the outlet areas 12 Remove the placement guidewire 13 Confirm position with fluoroscopy and confirm that an aortic waveform see Figure 5 19 is displayed on the Automated Impella Controller Maintaining ACT After insertion of the catheter and until explant ACT should be maintained at 160 to 180 seconds G 2 2 I m gt 5 m Jg 9 m E m 5 A 2 2 fe E m E I m 9 r 5 gt I m E m 2 PURGE SYSTEM Impella Flow Purge System __ 7 System Power a y Purge Flow 9 0 ml hr 100 0 0 Max 0 0 Figure 5 19 Aortic Waveform on Placement Signal Screen Impella 2 5 Catheter with the Automated Impella Controller 5 15 Wireless Insertion The Impella 2 5 Catheter must be visualized at all times Do NOT apply excessive force on the catheter when advancing it across the aortic valve The spring characteristics and robust catheter design should make it easy for the catheter to cross the aortic valve and move into position Unsuccessful Wireless Insertion Persistent unsuccessful attempts at wireless insertion of the Impella 2 5 Catheter will require reverting to the standard wired procedure resulting in an overall longer placement time WIRELESS INSERTION OF THE IMPELLA 2 5 CATHETER NOTE Wireless insertion should be limited to procedures using the Next Generation
104. etic Enforcement Guidance RF Emissions Group 1 The Automated Impella Controller uses RF energy only for CISPR 11 Class A its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Harmonics Class A The Automated Impella Controller is suitable for use in IEC 61000 3 2 all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Flicker Complies IEC 61000 3 3 TABLE 202 Guidance and Manufacturer s Declaration Immunity The Automated Impella Controller is intended for use in the electromagnetic environment specified below The customer or user of the Automated Impella Controller should ensure that it is used in such an environment IEC 60601 Compliance Electromagnetic Environment Guidance Electrostatic 6 kV contact 8 kV contact Floors should be wood Discharge ESD IEC 48 ky air 15 kV air concrete or ceramic tile If 61000 4 2 floors are synthetic the relative humidity should be at least 30 Electrical Fast 2 kV Mains 2 kV Mains Mains power quality should be Transient burst 1 KV for input 1 KV for input that of a typical commercial or 61000 4 4 output lines output lines hospital environment Surge 1 kV Differential 1 kV Differential Mains power quality should be IEC 61000 4 5 2 kV Common 2 kV Common
105. etting Unable to achieve set flow rate or performance level Check for high afterload pressure Open PURGE SYSTEM menu and select Change Purge Fluid Follow the instructions to change the purge fluid The purge flow has increased by 2 5 mL hr or more This is a notification only no action is required The purge flow has decreased by 2 5 mL hr or more This is a notification only no action is required Impella Catheter position unknown due to low pulsatility Assess cardiac function 1 Confirm Impella position with imaging 2 Follow repositioning guide if needed Cause Battery has 50 remaining capacity Loss of communication to the battery There is a problem with the purge cassette software There are 15 mL in addition to 5 of the starting bag volume or fewer remaining in the purge fluid bag Motor speed has been reduced in response to suction Reverse flow has been detected and minimum motor speed has been increased to more than target flow or target performance level There are 30 mL in addition to 5 of the starting bag volume or fewer remaining in the purge fluid bag Purge flow has increased by 22 5 mL hr Purge flow has decreased by 22 5 mL hr Impella Catheter position unknown due to low pulsatility Impella Catheter position unknown detected by algorithm Instructions for Use amp Clinical Reference Manual US Table 7 2 Automated Impella Control
106. f the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference 2 This device must accept any interference received including interference that may cause undesired operation Changes or modifications not expressly approved by Abiomed Inc could void the user s authority to operate this device ELECTROMAGNETIC COMPATIBILITY Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the electromagnetic compatibility EMC information provided in this document Portable and mobile RF communications equipment 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 should be observed to verify normal operation in the configuration in which it will be used Use of cables other than those sold by Abiomed may result in increased emissions or decreased immunity of the Automated Impella Controller The Automated Impella Controller uses RFID radio frequency identification to identify and communicate with the purge cassette Other equipment may interfere with the Automated Impella Controller even if that other equipment complies with CISPR emission requirements During transport the Automated Impella Controller may be exposed to stronger electromagnetic disturbance tha
107. f the Impella Catheter 6 5 Transesophageal Echocardiographic TEE Illustrations of mpella Catheter Position 6 8 Transthoracic Echocardiographic TTE Illustrations of mpella Catheter Position 6 9 Correct and Incorrect Impella Catheter Position Color Doppler TTE sssrini 6 10 Correct Impella Catheter Position 6 12 mpella Catheter Fully in 6 13 mpella Catheter Completely in the Aorta or Inlet and Outlet Areas in Ventricle and Open Pressure Area in 6 14 mpella Catheter Position 6 15 mpella Catheter Outlet Area on or near Aortic Valve 6 16 First Repositioning Guide 6 20 Second Repositioning Guide Screen 2 6 20 Third Repositioning Guide Screen 6 21 Exit Repositioning Guide 5 6 21 Displacing Air During Flush Solution Change Out Procedure 6 23 Automated Impella Controller Patient Environment 8 9 Impella 2 5 Catheter Dimensions 8 11 Impella Set up and Insertion Kit lt 3 2
108. from kinking do not allow the red Impella plug to hang freely from the catheter and do not bend the catheter near the red Impella plug Consider attaching the red Impella plug and catheter to a short armboard to prevent the catheter from kinking near the plug e Use care when moving or turning a patient the Impella Catheter may move out of position and cause a positioning alarm e Monitor pedal pulses TRANSPORT WITHIN THE HOSPITAL Patients supported with the Impella System may require transport within the hospital for various reasons Transport can be safe and simple for patients supported with Impella Catheter Considerations for transport within the hospital e The Automated Impella Controller and Impella Catheter are designed to operate on Battery Power Note battery power for at least 1 hour e Confirm that the battery capacity displayed on the controller is 100 If the Automated Impella Controller is allowed to discharge completely and the system shuts down due e f transport time might be longer than 1 hour bring an extension cord or confirm that you will be able to connect the controller to AC power once you arrive at your destination to low battery the controller Use care when rolling the Automated Impella Controller cart and pay close attention will need to charge for an when going over thresholds and through elevator doors extended period of time before it will turn on again e Do not stress
109. g the first use by Abiomed clinical Warnings alert you to support personnel certified in the use of Impella situations that can cause Fluoroscopy is required to guide placement of the Impella Catheter The small placement guidewire must be reliably observed at all times red rnise A appears before warning messages Be sure that the stopcock on the peel away introducer or repositioning sheath is always kept in the closed position Significant bleed back can result if the stopcock is open Avoid manual compression of the inlet and outlet areas of the cannula assembly The sterile components of the Impella System can be used only if the sterilization indicators show that the contents have been sterilized the packaging is not damaged and the expiration date has not elapsed Do NOT resterilize or reuse the Impella Catheter It is a disposable device and is intended for single use only Reuse reprocessing or resterilization may compromise the structural integrity of the catheter and or lead to catheter failure which in turn may result in patient injury illness or death Retrograde flow will occur across the aortic valve if the Impella Catheter is set at a flow rate of less than 0 5 L min To prevent malfunction of the locking mechanism of the peel away introducer do NOT hold the hemostatic valve while inserting into the artery To prevent failure of the peel away introducer remove the peel away introducer prior to
110. ge system The purge cassette delivers rinsing fluid to the Impella Catheter The purge fluid typically 20 dextrose solution flows from the purge cassette 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 upright and facing you The image of the purge fluid appears on the left with arrows pointing toward the image of the person on the right Figure 3 6 illustrates the purge cassette and related components Table 3 3 describes each component Purge Pressure EN Transmitter K Y Connector Purge Tubing Purge Fluid Spike Purge Cassette SS Yellow D N Connector A Supply Line Figure 3 6 Purge Cassette Impella 2 5 Catheter with the Automated Impella Controller 3 7 E I m lt 9 gt A gt I m gt r4 Jg o gt 0 m c gt o fe 2 E fe Table 3 3 Purge Cassette Components Component Description Purge fluid spike One end spikes the purge fluid bag and the other end connects the bag to the purge cassette supply line Supply line Carries fluid from the purge fluid bag to the purge cassette Purge cassette Contains the components for delivering the purge fluid maintains the pressure barrier between the blood and the motor to prevent blood from
111. he sterilization indicators show that the contents have been sterilized the packaging is not damaged and the expiration date has not elapsed Do NOT resterilize or reuse the Impella Catheter It is a disposable device and is intended for single use only To prevent malfunction of the Automated Impella Controller avoid long term exposure to direct sunlight and excessive heat 40 C To prevent overheating and improper operation do NOT block the cooling vents of the Automated Impella Controller while it is operating The Li lon 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 the Automated Impella Controller will operate for at least 60 minutes after the batteries have been fully charged Have a backup Automated Impella Controller purge cassette connector cable and Impella Catheter available in the unlikely event of a device failure SUPPLIES NEEDED e Automated Impella Controller Impella Catheter Set up and Insertion kit Diagnostic catheter AL1 or MP without side holes or pigtail with or without side holes e 500 cc bag of dextrose solution for purge solution 20 recommended 5 to 40 acceptable with 50 IU heparin mL 5 2 Instructions for Use amp Clinical Reference Manual US TURNING ON THE AUTOMATED IMPELLA CONTROLLER To turn the controller on 1 Press an
112. heter in the manner described in section 5 of this manual Increase flow rate to at least 1 5 L min 4 Place the MNS magnets in the Navigate position and proceed with magnetic navigation Keep operating the Impella9 Catheter at a flow rate of at least 1 5 L min when the MNS magnets are in the Navigate position If the flow rate falls below 1 5 L min the Impella Catheter may stop running To resume operation follow the steps in Table 6 4 v 2 m 2 lt gt 2 gt 2 m lt 2 ES u During magnetic navigation of the mapping catheter the motor current of the Impella Catheter may temporarily increase to the point that the catheter stops running Table 6 4 explains how to resume operation When the MNS magnets are in the Navigate position the displayed Impella Catheter flow may be artificially elevated To accurately assess the flow rate note the displayed flow when the magnets are the Stowed position Table 6 4 Troubleshooting When Operating the Impella Catheter in the Presence of a MNS System Observation Actions Unable to start Impella 1 Place the MNS magnets in the Reduced position and or attempt to start the Impella Catheter Impella stops running If the Impella Catheter does NOT start with the magnets in the Reduced position place the magnets in the Stowed position and start the Impella Catheter Increase the Impella Catheter flow rate to 1 5
113. ient support to the Impella9 Console perform the patient management checklist items described on the previous page Impella 2 5 Catheter with the Automated Impella Controller m 2 gt 2 gt 2 m 2 22 u TRANSFERRING FROM AN IMPELLA CONSOLE TO THE AUTOMATED IMPELLA CONTROLLER To transfer a patient from an Impella Console to an Automated Impella Controller follow the steps below 1 Gather the following items prior to transferring support e Automated Impella Controller White connector cable e Purge cassette e Purge solution recommended 20 dextrose with 50 IU mL of heparin Turn on the Automated Impella Controller Open the purge cassette and spike a new bag of purge solution Insert the purge cassette into the controller Open the white connector cable and plug it into the controller Disconnect the blue cable from the Impella Catheter Connect the white connector cable to the Impella Catheter oN DM PWN Once the Impella Catheter is connected to the new controller a message will appear on the screen asking you to confirm re starting the catheter at the previously set flow rate The Impella Console will still be purging the catheter at this point 9 Press OK within 10 seconds to confirm restarting the Impella Catheter 10 Press PURGE SYSTEM on the Automated Impella Controller and select Change Purge Fluid NO
114. imizes the Impella 2 5 Catheter flow for 5 minutes At the end of 5 minutes the controller retuns to the AUTO setting If the motor speed required to achieve a target flow rate exceeds the expected motor speed the controller will automatically reduce the flow by 0 1 L min after 5 minutes P LEVEL MODE If flow calculation is not possible the controller will switch to performance mode to allow you to set the motor speed for the Impella Catheter You can select one of ten performance levels PO to P9 for the Impella Catheter see Table 5 2 Select the lowest performance level that will enable you to achieve the flow rate necessary for patient support Table 5 2 Performance Level Flow Rates Flow Rate Revolutions Per L min Minute rpm 0 0 0 0 0 0005 25 000 0 4 1 0 35 000 P3 O 13 38 000 P4 0 9 15 40 000 5 1 2 43 000 P6 1 4 2 0 45 000 P7 16 2 2 47 000 19 25 50 000 Performance Level PO Impella Catheter motor is stopped P1 Flow rate increases as the performance level increases P8 Recommended maximum performance level for continuous use Used to confirm stable position after 21 2 6 placement be used to provide maximum flow for up to 5 minutes After 5 minutes the Automated Impella Controller will automatically default to P8 51 000 Flow rate can vary due to suction or incorrect positioning You can enable P level mode through the MENU soft button To select a pe
115. ing guidance If guidance is not available use the repositioning guide to reestablish proper placement The repositioning guide is discussed later in this section If the Impella Catheter is completely out of the ventricle do not attempt to reposition the catheter across the valve without a guidewire The following pages describe possible placement conditions and the associated signal characteristics and alarm messages as well as actions to take for each Impella 2 5 Catheter with the Automated Impella Controller 6 11 m 2 lt gt 2 gt 2 m lt m 2 22 A u CORRECT POSITION If the Impella Catheter is in the correct position the placement screen will appear as shown in Figure 6 5 Impella 2 5 S N 123456 30 06 2011 05 30 FLOW CONTROL Impella Flow A4 Purge System _ System P ower 27 Max y m Lh o 2 5 L min 2 3 Min Purge Flow 9 0 ml hr 100 Figure 6 5 Correct Impella Catheter Position 6 12 Instructions for Use amp Clinical Reference Manual US IMPELLA CATHETER FULLY IN VENTRICLE If the Impella Catheter is fully in the ventricle the following alarm will appear Impella Position Wrong In this situation the placement screen will appear as shown in Figure 6 6 1 Confirm Impella position wi 2 Follow repositioning guide if needed FLOW CONTROL v m 2 gt 2 gt 2 m lt m 2 ES A u
116. ire e Connector cable e Purge cassette e Introducer kit Peel away introducer 13 Fr for Impella 2 5 Dilator 13 Fr for Impella 2 5 18 G Seldinger needle 10 cc syringe 0 035 inch stiff access guidewire 3 2 Instructions for Use amp Clinical Reference Manual US SYSTEM CONFIGURATIONS Figure 3 2 illustrates how the Automated Impella Controller connects to the Impella Catheter and accessory components in the initial set up configuration Dextrose Solution Automated Impella Controller MN Impella Catheter SABIOMED Connector Cable Purge Cassette Y Connector Figure 3 2 Set up Configuration of the Automated Impella Controller Impella Catheter and Accessories Figure 3 3 illustrates the standard configuration of the Impella Catheter Automated Impella Controller and accessory components s Dextrose Solution Y Automated Impella Controller Sodium Chloride NaCl Solution in Pressure Bag O ae DEN we Impella Catheter lao E H E Caseta Connector Cable 2 o etam Ed S gt oC mia Y Connector SO m Figure 3 3 Standard Configuration of the Automated Impella Controller Impella Catheter and Accessories Impella 2 5 Catheter with the Automated Impella Controller 3 3 E I m lt 9 gt A gt I m gt Z Jg gt gt 0 m c gt o
117. isplayed at the top of the list The calculations begin when the case start procedure is completed and Impella Catheter flow rate is greater than 0 L min The infusion history screen updates after each milliliter of purge fluid is delivered and after each unit of heparin and dextrose is delivered Use the DISPLAY soft button to navigate to the infusion history screen Figure 4 6 shows a sample infusion history screen Impella 2 5 Catheter with the Automated Impella Controller Purge Pressure Depends on System Configuration When in the initial set up configuration the purge pressure Is set to 600 mmHg with flows between 2 and 30 mL hr After switching to the standard configuration the purge pressure is set to ideal pressure and flow for the particular catheter The pressure can be between 300 and 1100 mmHg and flows between 2 and 30 mL hr 4 11 v G 2 a E gt gt Jg lt ES m Fr 5 A fe 2 fe A Purge Flow In the initial set up configuration of the Impella System purge flow is regulated to keep the purge pressure at 600 mmHg although it may not reach 600 mmHg in low resistance catheters in this configuration In the standard configuration purge flow can range from 2 to 30 mL hr and purge pressure can range from 300 to 1100 mmHg 4 12 Impella 2 5 S N 123456 Infusion History lt mg hr nf De
118. ler Alarm Messages continued Severity Alarm Header Action Cause Audio Off The auditory signal for the following alarm has been disabled lt Alarm will be listed here gt User has disabled audio for Impella Sensor Failure Purge Flow Low or Purge System Blocked alarm Flow Control mode has been disabled P Level mode has been enabled Flow Control should be re enabled once this notification has resolved Flow Control Disabled AC Power Disconnected Controller is running on battery power AC power was disconnected Transfer to Standard Configuration Follow instructions under Purge System Follow instructions or press MUTE to transfer to Standard Configuration ALARM to clear the alarm for 30 2 lt gt 2 gt gt lt Purge Cassette Incompatible Contact Abiomed Service to update Impella Controller Impella 2 5 Catheter with the Automated Impella Controller minutes Incompatible purge cassette RFID version 1 7 gt lt gt m Jg m gt A 2 E fe i A gt m gt EL lt 8 GENERAL SYSTEM INFORMATION TERMINOLOGY ABBREVIATIONS AND SYMBOLS enn 8 1 Terminology and Abbreviations senes 8 1 Sm 8 1 AUTOMATED IMPELLA CONTROLLER MECHANICAL SPECIFICATIONS 8 3 AUTOMATED IMPELLA CONTROLLER ELECTRICAL SPECIFICATI
119. ler Failure Impella Disconnected Emergency Shutdown Imminent Controller Failure Battery Failure Battery Temperature High Battery Critically Low Battery Failure Air in Purge System Action 1 Restart Impella 2 Replace Impella after 3rd unsuccessful restart attempt Switch to backup controller 1 Replace white connector cable 2 Switch to backup controller 3 Replace Impella Catheter Switch to backup controller Check cable connection to console Check Impella connection to cable Release ON OFF push button The purge system has stopped Switch to backup controller Plug controller into AC power Press switch located on the underside of the controller Switch to backup controller Switch to backup controller Plug controller into AC power Plug controller into AC power The purge system has stopped Initiate the De air Tool and follow instructions to remove the air from the system Impella 2 5 Catheter with the Automated Impella Controller Cause There may be a mechanical or electrical problem in the Impella Catheter There is a problem with the controller electronics There is a problem with the electronics There is a problem with the controller electronics Running Impella Catheter disconnected Power switch pressed for 15 seconds while Impella Cathstill connected The controller has detected a purge pressure sensor defect and has
120. less insertion of the Impella 2 5 Catheter avoid twisting the catheter more than 360 Doing so will tangle the connector cable and purge tubing To reduce the likelihood of twisting or stressing the clear sidearm ensure that the clear sidearm is clipped to the connector cable and is rotating with the red Impella plug When in the initial set up configuration carefully inspect the catheter for kinking In this configuration occlusion alarms will not sound If the Impella9 2 5 Catheter must be removed from the patient carefully rinse the catheter with heparinized saline solution to prevent blood from clotting on it when it is exposed to air Use a new clean basin to ensure the catheter will not come in contact with any loose fibers that could interfere with the operation of the motor Instructions for Use amp Clinical Reference Manual US POSITIONING AND STARTING THE IMPELLA CATHETER Retrograde flow will occur across the aortic valve if the Impella Catheter is set at a flow rate of less than 0 5 L min 1 Place the catheter plug at the same level as the patient s heart 2 Reconfirm that the placement guidewire has been removed Also reconfirm that the controller displays an aortic waveform refer back to Figure 5 19 and the inlet area of the catheter is 3 5 cm below the aortic valve See step 7 if the controller displays a ventricular waveform 3 Press the FLOW CONTROL soft button to open the menu see Figure 5 20 S
121. lized in the syringe Disconnect the syringe and open the roller clamp until slow drips of saline exit the tubing Flood the open port of the red pressure sidearm and then reconnect Squeeze the white wings of the flow valve for 15 to 20 seconds to flush the pressure lumen to remove all blood from the pressure lumen Maintain the pressure level between 300 mmHg and 350 mmHg by checking it every 1 to 3 hours FLUSH SOLUTION CHANGE OUT PROCEDURE 1 Prime the new NaCl flush solution setup and close the roller clamp 2 Place the NaCl bag a pressure bag and inflate to between 300 mmHg and 350 mmHg 3 Close the roller clamp and disconnect the old flush solution connected at the red sidearm port Instructions for Use amp Clinical Reference Manual US 4 Open the roller clamp on the new flush solution setup until you get a slow drip 5 Position the male luer connector over the female luer connector and fill to overflow displacing any air as shown in Figure 6 14 Figure 6 14 Displacing Air During Flush Solution Change Out Procedure 6 Connect and secure luer fittings 7 Fully open the roller clamp and squeeze the white wings for approximately 5 to 10 seconds to complete the internal prime This final prime should eliminate any risk of lost or dampened pressure caused by blood tracking into the pressure lumen during the pressure tubing change TIMED DATA RECORDING The Automated Impella Controller
122. ller should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Impella Controller 9 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m Impella 2 5 Catheter with the Automated Impella Controller 8 7 8 8 TABLE 205 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Automated Impella Controller Equipment and Systems that are Life Supporting The Automated Impella Controller is intended for use in the electromagnetic environment in which radiated disturbances are controlled The customer or user of the Automated Impella Controller can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment and the Automated Impella Controller as recommended below according to the maximum output power of the communications equipment Rated Maximum Recommended Separation Distances Output for the Automated Impella Controller m Output Power 150 KHzto80MHz 8010800 MHz 800 MHz to 2 5 GHz of Transmitter d 0 354 d 0 6 P d 1 2 P Watts 0 01 0 04 0 06 0 12 0 1 0 11 0 19 0 38 1 0 35 0 6 11 2 10 1 11 1 9 3 8 100 6 0 12 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the eq
123. mated Impella Controller Section 7 Automated Impella Controller Alarms provides a listing of Automated Impella Controller alarms as well as information on what to do to resolve them Section 8 General System Information contains information including definitions for key terms that appear in the manual descriptions of the abbreviations and symbols that appear on Impella Catheter and Automated Impella Controller components and packaging technical information pertaining to the Impella Catheter and Automated Impella Controller and instructions on cleaning and storing system components as well as returning components to Abiomed Appendices at the end of the manual provide supplemental information about topics including the Impella Limited Service Warranty Abiomed approved guidewires and introducers the Automated Impella Controller menu structure and axillary insertion technique Impella 2 5 Catheter with the Automated Impella Controller 1 WARNINGS AND CAUTIONS tuUI cct 1 1 e giu r 1 3 WARNINGS A A A A A A A A A A A A A A A Use of the Impella System by trained and experienced practitioners has been associated with improved outcomes Consequently the first use of Impella should SS be preceded by the completion of a contemporary Abiomed Impella training program and include on site proctoring durin
124. ment If adjacent or stacked use is necessary the equipment or system should be observed to verify normal operation in the configuration in which it will be used Use of cables other than those sold by Abiomed may result in increased emissions or decreased immunity of the Automated Impella Controller The Automated Impella Controller uses RFID radio frequency identification to identify and communicate with the purge cassette Other equipment may interfere with the Automated Impella Controller even if that other equipment complies with CISPR emission requirements Infusion through the sideport of the introducer can be done only after all air is removed from the introducer If performed the infusion should be done for flushing purposes only and NOT for delivering therapy or monitoring blood pressure A A A A A A A A A A A A 1 2 Instructions for Use Clinical Reference Manual US CAUTIONS A A A A A A A A A A A A A A A Handle with care The Impella Catheter can be damaged during removal from packaging preparation insertion and removal Do MOT bend pull or place excess pressure on the catheter or mechanical components at any time Cautions 1 a Cautions indicate situations Patients with aortic stenosis or other abnormal aortic valve performance may be had compromised by the use of the Impella Catheter Patients with aortic valve disease equipment may should be observe
125. n during in hospital use Strong electromagnetic disturbance may cause the Automated Impella Controller to display soft button menu selections that were not selected by the user Operators should be aware that under these conditions the operating parameters are not affected No user intervention is required Monitor Impella 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 disturbance NOTE The EMC tables and other guidelines that are included in this manual provide information to the customer or user that is essential in determining the suitability of the equipment or system for the electromagnetic environment of use and in managing the electromagnetic environment of use permit the equipment or system to perform to its intended use without disturbing other equipment and systems or non medical electrical equipment Impella 2 5 Catheter with the Automated Impella Controller 8 5 8 m 2 m 2 gt lt m 2 T 2 2 8 6 TABLE 201 Guidance and Manufacturer s Declaration Emissions All Equipment and Systems The Automated Impella Controller is intended for use in the electromagnetic environment specified below The customer or user of the Automated Impella Controller should ensure that it is used in such an environment Emissions Test Compliance Electromagn
126. n the recommended separation distances calculated listed below 8 Immunity Test m 2 m 2 gt lt m 2 T 2 2 Conducted RF 10 Vrms 10 Vrms d 0 354 P IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 10 V m d 0 64 IEC 61000 4 3 80 MHz to 2 5 GHz 80 to 800 MHz d 124 P 800 MHz to 2 5 GHz Where P is the maximum power rating in watts and d is the recommended separation distance in meters Field strengths from fixed transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 2 NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Impella Controller is used exceeds the applicable RF compliance level above the Impella Contro
127. ndicator of right heart failure If the Automated Impella Controller detects suction it automatically reduces motor speed to lower the flow rate to resolve the suction and displays the Impella Flow Reduced advisory alarm If the suction is cleared the controller returns the flow rate to the desired setting If suction is still detected at the lowest motor speed the controller displays the Suction alarm If the Suction or Impella Flow Reduced alarm occurs follow the recommended actions 1 Check the Impella Catheter for correct positioning using imaging Reposition the catheter by rotating or moving it into or out of the ventricle slightly Either or both of these actions could help move the inlet of the Impella Catheter away from the interior ventricular wall 2 Assess patient s fluid intake and output to confirm adequate volume status Confirm right ventricular function by assessing CVP or right side function with echocardiography If CVP is not an option check the pulmonary artery diastolic pressure to assess the patient volume status 4 Return flow rate to pre alarm setting HEMOLYSIS When blood is pumped it is subjected to mechanical forces Depending on the strength of the blood cells and the amount of force applied the cells may be damaged allowing hemoglobin to enter the plasma Pumping forces can be generated by a variety of medical procedures including heart lung bypass hemodialysis or ventricul
128. nnot be confirmed While other imaging techniques such as transesophageal echocardiography TEE portable C Arm fluoroscopy or chest x ray can help confirm the position of the Impella Catheter after placement these methods do not allow visualization of the entire catheter assembly and are inadequate for reliably placing the Impella Catheter across the aortic valve Introducer Setup Refer to the instructions for use for each introducer for setup instructions GP Inhibitors If the patient is receiving a GP 116 inhibitor the dilator can be removed and the Impella Catheter inserted when ACT is 200 or above INSERTING THE IMPELLA CATHETER WIRED INSERTION NOTE Proper surgical procedures and techniques are the responsibility of the medical professional The described procedure is furnished for information purposes only Each physician must evaluate the appropriateness of the procedure based on his or her medical training and experience the type of procedure and the type of systems used Fluoroscopy is required to guide placement of the Impella Catheter The small placement guidewire must be reliably observed at all times Avoid manual compression of the inlet and outlet areas of the cannula assembly To prevent malfunction of the locking mechanism of the peel away introducer do NOT hold the hemostatic valve while inserting into the artery Do NOT kink or clamp the Impella Catheter
129. nts Disconnecting the Y connector figure 5 23 Y connector icon 4 8 INDEX 00 CABIOMED Recovering hearts Saving lives Clinical support 24 hours per day 7 days a week 1 800 422 8666 US 49 0 1805 2246633 EU www abiomed com Abiomed Inc 22 Cherry Hill Drive Danvers Massachusetts 01923 USA Voice 978 777 5410 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
130. o the Alarm Delay Information discussion in section 8 of this manual Impella 2 5 Catheter with the Automated Impella Controller 7 1 Alarms That Resolve On Their Own The audible indicator will shut off ifan alarm condition is resolved before you press MUTE ALARM The visual message however will continue to be displayed with the alarm header on a gray background for 20 minutes or until you press MUTE ALARM This allows you to identify the alarm that occurred 7 2 ALARM DISPLAY The alarm window is located in the upper left region of the display screen on the front of the Automated Impella Controller see Figure 7 1 Alarms are listed in order of priority with the highest priority alarm at the top Up to three alarms may be displayed at one time The colored background behind the highest priority alarm will alternate between two shades of that color The white panel displayed to the right of the alarm header contains instructions for resolving the alarm condition The instructions should be followed in the order given Mute Alarm Indicator Confirm Impella position with imaging Follow repositioning guide if needed Alarm Check left side filling and volume status A Window Check Impella position Reduce flow or performance level The purge flow has increased by 2 5 mL hr or more This is a notification only no action is required FLOW __ CONTROL SYSTEM Imp
131. of fluoroscopic imaging If no fluoroscopy is available leave the catheter in the descending aorta until fluoroscopy is available for visual assistance during removal of the Impella Catheter Instructions for Use amp Clinical Reference Manual US PURGE SYSTEM OPEN If at any time during the course of support with the Impella Catheter the Automated Impella Controller alarms Purge System Open follow the instructions below 1 Inspect the purge system for leaks 2 If no leaks are visible there may be a problem with the purge cassette Replace the purge cassette Refer to instructions earlier in this section of the manual 3 If the Purge System Open alarm remains unresolved this may be a sign of Impella Catheter damage Complete the following steps immediately a Open the FLOW CONTROL meter and reduce the flow rate to 0 5 L min b Slowly pull back on the Impella Catheter until it is in the descending aorta approximately 20 cm for an average size patient 1 cm marks are available on the catheter c Turn off the Impella Catheter by opening the FLOW CONTROL meter and reducing the flow rate to 0 L min d Disconnect the catheter from the Automated Impella Controller e Remove the Impella Catheter with the use of fluoroscopic imaging If no fluoroscopy is available leave the catheter in the descending aorta until fluoroscopy is available for visual assistance during removal of the Impella Cathet
132. of the purge cassette door for proper placement Slide the purge pressure transmitter into the slot to the right of the purge cassette until it snaps into place The controller will automatically begin priming the purge cassette Extend the purge tubing and close the purge cassette door There is sufficient room around the edges of the purge cassette door so that it will not pinch the purge tubing as it exits The controller automatically begins priming the purge cassette after it is inserted The progress bar shown in Figure 5 3 marks the progress of the purge cassette priming Instructions for Use amp Clinical Reference Manual US CONNECT THE IMPELLA CATHETER 1 Remove the Impella Catheter from its package using sterile technique and inspect the catheter including its connector for damage 2 Remove the white connector cable from its package using sterile technique 3 Inspect the cable for damage including damage to the connector pins at the controller end 4 Secure the black end of the cable to the sterile field 5 Insert the catheter plug into the connector cable socket black end The tab and the slot must be aligned during connection see Figure 5 5 2 Catheter Plug N Connector Cable Socket black end 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 plastic clip located on the pressu
133. ontroller and the Impella Catheter Patients are placed on the Automated Impella Controller for circulatory support for periods up to 6 hours If during this time a patient requires additional resources and specialized teams at another location eg a larger facility such as a transplant center the patient may be transferred safely to such a location using the Automated Impella Controller Maintaining optimal patient hemodynamic status and correct Impella Catheter position are two key factors in managing patients supported with the Impella System during 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 minutes on battery power Transport teams should take this into consideration when planning the transport If the total transport time is expected to include more than 60 minutes during which the system will be disconnected from AC power arrangements should be made to use a vehicle with a built in DC to AC power inverter IMPORTANT TRANSPORT CONSIDERATIONS 1 Planning is critical to success Abiomed representatives can help with planning for transport They can be contacted 24 hours a day at 1 800 422 8666 2 The Automated Impella Controller should be fully charged prior to transport Keep the Automated Impella Controller connected to AC power or an AC inverter whenever possible
134. or the peel away introducer Handle with care The Impella Catheter can be damaged during removal from packaging preparation insertion and removal Do NOT bend pull or place excess pressure on the catheter or mechanical components at any time 1 Obtain access to the femoral artery 2 Insert a 5 8 Fr introducer over the 0 035 guidewire provided to pre dilate the vessel 3 Remove the 5 8 Fr introducer over the 0 035 guidewire Insert a 10 Fr dilator and then remove it and insert the peel away introducer with dilator see Figure 5 14 While inserting the introducer hold the shaft of the introducer to slide it into the artery Figure 5 14 Inserting the Peel Away Introducer 4 Administer heparin When the ACT is 250 or above remove the dilator Instructions for Use amp Clinical Reference Manual US 5 Insert a diagnostic catheter with diagnostic guidewire Abiomed recommends a 6 Fr or Multipurpose without side holes or 4 5 Fr pigtail with or without side holes into the introducer and advance it over a diagnostic guidewire into the left ventricle Figure 5 15 Inserting the Diagnostic Catheter 6 Remove the 0 035 inch diagnostic guidewire leaving the diagnostic catheter in the ventricle Form a curve or bend on the end of the 0 018 inch 260 cm placement guidewire and then insert it 7 Advance the placement guidewire into the left ventricle to the apex 8 Remove the diagnostic catheter To backload the
135. ortic valve 6 4 ECG INTERFERENCE Operating the Automated Impella Controller may cause interference with electrocardiogram ECG signals Please check the electrode pads and leads for good fixation and contact If interference persists activate the 50 100 Hz band elimination filter or the 60 120 Hz band elimination filter also known as notch filter on your ECG device The filter frequency will be based on the AC power frequency for the country in which you are operating the equipment If your ECG device does not have the appropriate filters disconnect the Automated Impella Controller temporarily from AC power to obtain an undisturbed signal Please observe the battery status while running the Automated Impella Controller on battery power LATEX The Automated Impella Controller Impella Catheter and all accessories approved by Abiomed are 100 latex free USE OF ECHOCARDIOGRAPHY FOR POSITIONING OF THE IMPELLA CATHETER BACKGROUND Echocardiography is a commonly used tool for evaluating the position of the Impella Catheter relative to the aortic valve and other intraventricular structures post placement The best echocardiographic views for positioning the Impella Catheter in the left ventricle are a long axis transesophageal echocardiogram TEE or a parasternal long axis transthoracic echocardiogram TTE These long axis views allow you to see both the aortic valve and Impella Catheter inlet area Evaluate th
136. osition with imaging 2 Follow repositioning guide if needed Placement FLOW Signal CONTROL 90 10 37 10 sec Reposition Guide Active Pull Impella back until placement Signal shows aortic pressure Impella Flow 4 Purge System _ System Power 1 2 mm Ep 0 8 Min l 0 L min Purge Flow 9 0 ml hr 100 Figure 6 12 Third Repositioning Guide Screen 5 Pull the Impella Catheter back 4 centimeters as directed in the screen shown in Figure 6 13 Each mark on the catheter equals 1 centimeter Impella 2 5 S N 123456 30 06 2011 05 30 mpella Alarm condition resolved Position Wrong Placement FLOW _ Signal CONTROL Reposition Guide Active Pull Impella back 4 cm Confirm after completion flow will be restored to previous setting Impella Flow 4 Purge System __ System Power 1 2 Max y y 0 8 Min 1 L min Purge Flow 9 0 ml hr 100 Figure 6 13 Exit Repositioning Guide Screen 6 Exit the Repositioning Guide using the Exit Repositioning Guide soft button shown in Figure 6 13 When you exit the controller returns to the original flow rate Impella 2 5 Catheter with the Automated Impella Controller Restoring Placement Signal Quality You may get a sensor or position alarm f you pinch the white flush valve to restore placement signal quality PLACEMENT SIGNAL LUMEN BACKGROUND The Impella Catheter uses
137. otten ie A 1 APPENDIX B ABIOMED APPROVED GUIDEWIRES AND INTRODUCERS B 1 Abiomed approved B 1 Alternative Qualified Introducer Sheaths see B 1 APPENDIX C AUTOMATED IMPELLA CONTROLLER MENU STRUCTURE C 1 OU C1 MUTE ALA Mision arrancan C1 FLOW CONTRO od C1 DISPL M MNT C 2 PURGE SYSTEM e C 2 MENU ED EIER C3 APPENDIX D AXILLARY INSERTION D 1 Supplies Needed io Frac net t nte t D 1 Overview of Surgical Technique for Axillary Insertion e D 1 OO 00 APPENDIX A IMPELLA SYSTEM LIMITED SERVICE WARRANTY UNITED STATES Abiomed Inc warrants that at the time of installation all Impella Systems the Goods sold will be free from defects in material and workmanship and remain free from defects under normal use and service for a period of one 1 year from the date of shipment Extended warranty and service may at Abiomed s option be offered for an additional charge in which event separate or additional terms and conditions may apply This warranty provides coverage for the Automated Impella Controller This warranty does not cover routine preventative maintenance or replacement parts that are consumed per the controller s periodic maintenance schedule outlined in the Operator s and Service Manual
138. pected flows Table 6 1 Guide for Managing Hemolysis in Various Circumstances Clinical Indicators Imaging see note Imaging see note Normal hemodynamics Native recovery e Low e Low PCWP e Low AOP e High PA pressures e Right heart failure e High urine output e Increased bleeding or chest tube drainage e Patient past medical history e Current procedures or treatments Management e Reposition the catheter by rotating or moving the catheter into or out of the ventricle slightly Either or both of these actions could help move the inlet of the catheter away from the intraventricular wall e f repositioning will be delayed reduce the flow rate if tolerated by patient hemodynamics Return to the target flow rate after repositioning e Reassess position after flow rate has returned to desired target value Reposition the catheter by rotating or moving the catheter into or out of the ventricle slightly Either or both of these actions could help move the inlet of the catheter away from the intraventricular wall e f repositioning will be delayed reduce the flow rate if tolerated by patient hemodynamics Return to the target flow rate after repositioning e Reassess position after flow rate has returned to desired target value e Reduce flow rate until patient pressure starts to drop e Slowly increase flow rate e Reduce the flow rate if tolerated by patient hemodynamics e Correct and O bal
139. pella Catheter inlet area can lead to increased mechanical forces on blood cell walls and subsequent hemolysis which often presents as dark or blood colored urine If the Impella Catheter is too far into the left ventricle echocardiography will likely show the following as depicted in Figures 6 2b TEE and 6 3b TTE e Catheter inlet area more than 4 cm below the aortic valve e Catheter outlet area across or near the aortic valve 6 6 Instructions for Use amp Clinical Reference Manual US IMPELLA CATHETER INLET IN THE AORTA If the inlet area of the Impella Catheter is in the aorta the patient will not receive the benefit of Impella Catheter support The catheter will pull blood from the aorta rather than the left ventricle In addition suction is possible if the inlet area is against the wall of the aorta or valve sinus If the inlet area of the Impella Catheter is in the aorta echocardiography will likely show the following as depicted in Figures 6 2c TEE and 6 3c TTE e Catheter inlet area in aorta or near the aortic valve Catheter pigtail too close to the mitral valve IMPELLA CATHETER IN PAPILLARY MUSCLE If the inlet area of the Impella Catheter is too close to or entangled in the papillary muscle and or subannular structures surrounding the mitral valve it can affect mitral valve function and negatively impact catheter flow If the inlet area of the catheter is lodged adjacent to the papillary muscle th
140. positioning PIP checklist 6 11 Power Power switch figure 5 3 System power area of display screen 4 7 Pressure measurement lumen 3 5 Pressure transducer 3 5 Pump Definition 8 1 Pump housing See Catheter Catheter components Motor housing Purge cassette See also Impella System Using the system Components Purge cassette 3 8 igure 3 7 Purge fluid spike 3 8 igure 3 7 Purge pressure transmitter 3 8 4 3 igure 3 7 4 2 Purge tubing 3 8 igure 3 7 Supply line 3 8 igure 3 7 Y connector 3 8 See also Y connector igure 3 7 Yellow luer connector 3 8 igure 3 7 Description 3 7 4 3 figure 3 7 4 2 Priming the purge cassette 5 6 figure 5 5 Purge cassette procedures 5 22 Purge fluid See Dextrose solution See Heparin Entering purge fluid information figure 5 10 Purge lumen 3 5 Priming the purge lumen 5 8 figure 5 8 Purge pressure Definition 8 1 Purge pressure and system configuration 4 11 5 21 5 26 Purge system See also Impella System Using the system Connecting purge tubing to connector cable figure 5 11 Purge cassette procedures 5 22 Purge flow 4 12 5 21 Purge flow display Description 4 11 figure 4 10 Purge pressure display Description 4 11 figure 4 10 Purge system area on display screen 4 8 Troubleshooting 5 26 High purge pressure 5 27 Low purge pressure 5 26 Purge system blocked 5 27 Purge system open 5 27 R Repositioning g
141. pressure measurements which are useful in determining intravascular pressure The Automated Impella Controller is intended to be used by trained healthcare professionals in healthcare facilities and medical transport ie ambulance helicopter or fixed wing aircraft environments CONTRAINDICATIONS UNITED STATES compromised by the use of the Impella Catheter Patients with aortic valve disease should be observed for aortic insufficiency i Patients with aortic stenosis or other abnormal aortic valve performance may be e Mechanical aortic valve or heart constrictive device e Aortic valve stenosis calcification graded as gt 2 equivalent to an orifice area of 1 5 cm or less z 9 2 Uu Z 2 gt Z 9 A a 2 Ce gt z Jg e m Z gt re gt g lt m m m lt m Z un e Moderate to severe aortic insufficiency echocardiographic assessment of aortic insufficiency graded as gt 2 e Severe peripheral arterial obstructive disease that would preclude Impella device placement Impella 2 5 Catheter with the Automated Impella Controller 2 1 POTENTIAL ADVERSE EVENTS UNITED STATES e Aortic insufficiency e Aortic valve injury e Arrhythmia e Atrial fibrillation e Bleeding e Cardiogenic shock e Cardiac tamponade e Cerebral vascular accident CVA Stroke e Death e Device malfunction e Hemolysis e Hepatic failure e
142. r shaft and allows repositioning of the catheter The anchoring ring of the anticontamination sleeve secures the The Repo ee ping sneak has sheath to the catheter a graduated inner diameter The StatLock compatible suture pads help secure the repositioning e Fr to 1a Fr The outer sheath to the patient s skin diameter is graduated Red Impella plug The red Impella plug at the proximal end of the catheter connects the from d to 15 Fr for the catheter to the Automated Impella Controller through a connector Impella 2 5 cable It contains e A pressure transducer that translates pressure for the pressure lumen proximal to the motor e Memory that retains operating parameters in case the patient needs to be transferred to another controller e The placement signal lumen that allows for pressure and waveform displays It has two sidearms a red pressure sidearm and a clear sidearm Repositioning Sheath Inner vs Outer Diameter E I lt 9 m 5 A gt I m m gt r4 Jg G lt gt m 9 m gt o fe 2 2 fe m Red pressure sidearm The red pressure sidearm is attached to a standard pressure bag and is used to prime the line of the pressure measurement system Clear sidearm The clear sidearm is attached to the purge cassette tubing It leads to the infusion filter the pressure reservoir and the check valve Infusion filter The infusion filter pre
143. re reservoir of the clear sidearm to the Important Step connector cable as shown in Figure 5 6 Snapping the plastic clip on the pressure reservoir to the connector cable is important to prevent the tube from kinking Figure 5 6 Snapping Plastic Clip to Connector Cable 8 Pass the sterile connector cable from the Impella Catheter off the sterile field Impella 2 5 Catheter with the Automated Impella Controller 5 7 e 2 a m gt gt Jg 9 5 A 2 J fe I m lt 9 r 5 gt I m E m Error Screens If you miss a step in the process of setting up the Impella Catheter or if you exceed the amount of time allowed to complete a step the Automated Impella Controller will display an error screen with instructions for continuing the setup process 5 8 9 Line up the notch on the connector cable with the notch in the blue catheter plug on the front of the Automated Impella Controller and plug the cable into the controller 10 Once the purge cassette is primed and the controller detects that the connector cable is plugged in it prompts you to connect the luer s to the Impella Catheter See Figure 5 7 Impella 2 5 S N 123456 30 06 2011 05 30 Prime Impella Purge Lumen 1 Insert purge cassette 2 Plug in Impella catheter cable 3 Connect the luer s once cassette is primed and the
144. required for use in medical facilities eg VDE 0100 VDE 0107 or ICE stipulations Observe country specific regulations and national deviations Impella 2 5 Catheter with the Automated Impella Controller 8 3 8 4 EQUIPMENT DESIGN The Automated Impella Controller conforms to the applicable requirements of the following standards e UL 60601 1 2003 1st Edition Medical Electrical Equipment Part 1 General Requirements for Safety e CAN CSA 22 2 No 601 1 M90 1990 Reaffirmed 2005 2nd Edition Medical Electrical Equipment Part 1 General Requirements for Safety e EN 60601 1 1990 2nd Edition Medical Electrical Equipment Part 1 General Requirements for Safety A1 93 A2 95 A1 3 96 e IEC 60601 1 1988 2nd Edition Medical Electrical Equipment Part 1 General Requirements for Safety A1 91 A2 95 e EC 60601 1 2 2001 Medical Electrical Equipment Part 1 2 General Requirements for Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests e EC 60601 1 4 2000 Edition 1 1 Consolidated Edition Medical Electrical Equipment Part 1 4 General Requirements for Safety Collateral Standard Programmable Electrical Medical Systems e EC 60601 1 1 2000 12 01 2nd Edition Medical Electrical Equipment Part 1 1 General Requirements for Safety Collateral Standard Safety Requirements for Medical Electrical Systems e IEC 60601 1 8 2003 08 01 E
145. rformance level 1 Press the FLOW CONTROL soft button 2 Turn the selector knob to increase or decrease the performance level 3 Press the selector knob to select the new performance level Impella 2 5 Catheter with the Automated Impella Controller Placement Monitoring Suspended When the Impella Catheter is operating in a low flow range placement monitoring may be suspended and the flow rate in the lower left corner of the controller display screen will turn yellow to indicate that Impella position is unknown Reverse Flow If the Impella Catheter flow is below 0 5 L min for more than 30 seconds and the controller detects reverse flow it will increase the motor speed 5 19 G 2 2 I m 5 m Jg 9 5 A 2 2 fe E I m lt 9 r Fr 5 gt I m E m USE OF THE REPOSITIONING SHEATH AND THE PEEL AWAY INTRODUCER To prevent failure of the peel away introducer remove the peel away introducer prior to transport when activated clotting time ACT is less than 150 seconds Be sure that the stopcock on the peel away introducer or repositioning sheath is always kept in the closed position Significant bleed back can result if the stopcock is Open 1 Flush the sidearm of the repositioning sheath located on the catheter shaft 2 Remove the peel away introducer completely from the artery over the catheter shaft
146. rier between the blood and the motor to prevent blood from entering the motor The purge cassette and its components are described in section 3 of this manual Spring loaded door that opens to provide access to the purge cassette Impella 2 5 Catheter with the Automated Impella Controller Display Options If equipped with a VGA connector the controller can be connected to a monitor to display information on another screen as described under Slave Monitor Connection in section 8 of this manual Selector Knob Function Rotate the selector knob on the controller to navigate through menu items Push the selector knob to confirm your selection 4 3 v 2 E gt gt lt 9 m 5 2 J fe A Figure 4 2 illustrates the features on the left and right sides of the Automated Impella Controller These features are described in Table 4 2 Bed Mount Purge Cassette Door Release VGA RS 232 Jack USB Connector Ethernet Jack Equipotential Ground Stud AC Fuses Power Switch Plug Figure 4 2 Automated Impella Controller Features Side Views 4 4 Instructions for Use 8 Clinical Reference Manual US Table 4 2 Automated Impella Controller Side View Features Feature Bed mount Purge cassette door release VGA RS 232 jack USB connector AC fuses AC plug Power switch Equipotential g
147. round stud Ethernet jack Description Metal bracket on the back of the controller attaches controller to the cart or bed Button located on the left side of the controller press to open the purge cassette door Interface for data transfer by Abiomed maintenance or service personnel if equipped this interface can also be used for connecting the controller to another monitor to slave the display Connection for data downloading by Abiomed maintenance or service personnel Electrical safety device in the event of current overload Connection point on the controller for the AC power cord Button that turns the controller on or off e ON Press and hold the power switch for 3 seconds e OFF 1 Disconnect the Impella Catheter from the Automated Impella Controller 2 Press and hold the power switch for 3 seconds 3 A pop up confirmation box will appear 4 Press OK using the selector knob to confirm that the controller should be turned off NOTE Holding down the power switch for longer than 30 seconds during operation will cause the controller to initiate an emergency shutdown Used to ground the Automated Impella Controller according to hospital procedures Connection for downloading data or software upgrades Impella 2 5 Catheter with the Automated Impella Controller 4 5 v G 2 E I gt gt lt 9 m m 5 A fe 2 J fe ez m Es
148. s The express warranty set forth on this page is the only warranty given by Abiomed with respect to any goods furnished hereunder Abiomed makes no other warranty express implied or arising by custom or trade usage and specifically makes no warranty of merchantability or of fitness for any particular purpose Said express warranty shall not be enlarged or otherwise affected by Abiomed s rendering of technical or other advice or service in connection with the Goods Abiomed shall not be liable for incidental or consequential losses damages or expenses directly or indirectly arising from the sale handling or use of the Goods or from any other cause relating thereto and Abiomed s sole responsibility under this warranty will be at its option to 1 repair or replace the Goods or any components of the Goods found to be defective in workmanship or material during the foregoing warranty period or 2 to refund the purchase price paid All replaced components and Goods will become the property of Abiomed This warranty shall not apply if the Goods have been a repaired or altered in any way by other than Abiomed or Abiomed authorized service personnel b subjected to physical or electrical abuse or misuse or c operated in a manner inconsistent with Abiomed s instructions for use of the Goods If Abiomed determines that a claim was not caused by Abiomed or Abiomed s authorized service personnel then Buyer shall pay Abiomed for all related co
149. s are within expected limits When a parameter goes outside of its specified limits the Automated Impella Controller sounds an alarm tone and displays an alarm message that can be viewed on the display screen on the front of the controller The alarm tone indicates the severity of the alarm The alarm message on the display screen is color coded for severity and provides details on the cause of the alarm and how to resolve the alarm After muting an alarm if another alarm occurs it will only be heard and displayed if it is a higher priority alarm than the one that was muted ALARM LEVELS Alarms are divided into three levels of severity e Advisory white e Serious yellow e Critical red gt lt gt m Jg 9 m E gt o fe 2 gt gt EL lt Table 7 1 Alarm Levels Category Description Audible Indicator Visual Indicator Advisory Notification 1 beep every 5 minutes Alarm header on white background Serious May become harmful or 3 beeps every 15 seconds Alarm header on life threatening if not yellow background addressed immediately Critical Immediately harmful or 10 beeps every 6 7 seconds Alarm header on life threatening red background Sound pressure of audible alarm indicators is gt 80 dBA For some alarms there is a short delay between the triggered event and the audible annunciation and visual display of the alarm For more information refer t
150. sette Check all purge system tubing for kinks or blockages Decrease concentration of dextrose in the purge solution Check purge system tubing for kinks 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 Catheter is not running possible reverse flow through Impella Catheter Reverse flow detected at high motor speed Controller has detected that Impella Catheter is in the wrong position There is a problem with the Impella Catheter motor There is a problem with the Impella Catheter motor Complete Procedure serious alarm yellow see next page is active and the user has not responded for an additional 2 minutes Purge pressure has dropped below 100 mmHg for 20 seconds or longer Purge pressure has dropped below 300 mmHg with the purge flow gt 30 mL hr for 30 seconds or longer Purge flow has dropped below 1 mL hr Kinked or blocked purge connecting tube Kinked or blocked purge lumen in Impella Catheter Purge pressure is gt 1100 mmHg with the purge flow lt 2 mL hr The controller is not detecting that the purge pressure transmitter is clicked into the front of the controller Instructions for Use amp Clinical Reference Manual US Severity Alarm Header Complete Procedure Controller Error Impella Defective
151. sicians and device operators monitor the correct positioning and functioning of the Impella Catheter on the display screen of the Automated Impella Controller This section describes the components of the Impella Catheter and the Automated Impella Controller as well as the accessory components Impella 2 5 Catheter with the Automated Impella Controller 3 1 E I m lt 9 5 A gt I m gt Z Jg gt lt 0 m gt o fe 2 E fe m m REUSABLE SYSTEM COMPONENTS The Impella System consists of the following reusable components e Automated Impella Controller provides the user interface alarm indications and portable battery e Automated Impella Controller cart for easy transport of the Automated Impella Controller SINGLE USE SYSTEM COMPONENTS The Impella System also includes the following single use components e Impella Catheter e Purge cassette e Introducer kit 0 018 inch 260 cm placement guidewire e Connector cable IMPELLA SET UP AND INSERTION KIT The components of the Impella System are packaged into a single box called the Impella Set up and Insertion kit Table 3 1 describes the contents of this kit Table 3 1 Impella Set up and Insertion Kit Components The Impella Set up and Insertion kit contains the following e Impella Catheter e 0 018 inch 260 cm placement guidew
152. stopped the purge system A battery switch is turned off or there is a malfunction of the switch Battery temperature is greater than 60 C Battery power has 15 remaining capacity One of the batteries has failed There is air in the purge tubing 7 3 gt gt m Jg lt 0 m m gt e fe 2 2 fe m m A gt Fr gt E 3 7 7 4 Table 7 2 Automated Impella Controller Alarm Messages continued Severity 5 lt 76 T U Alarm Header Purge System Failure Impella Stopped Reverse Flow Reverse Flow Impella Position Wrong Impella Failure Impella Stopped Motor Current High Complete Procedure Purge System Open Purge Pressure Low Purge System Blocked Purge Flow Low Purge Line Click On Not Detected Action 1 Replace purge cassette 2 Switch to backup controller Restart Impella or remove Impella from ventricle Check for high afterload pressure 1 Confirm Impella position with imaging 2 Follow repositioning guide if needed Replace Impella Restart Impella Replace Impella after 3rd unsuccessful restart attempt Follow the steps on the screen or Exit the procedure Check the purge system tubing for open connections or leaks Replace purge cassette Check purge system tubing for leaks Increase concentration of dextrose in the purge solution Replace purge cas
153. sts incurred by Abiomed This warranty is not transferable without the express written consent of Abiomed Under this warranty Abiomed will provide at no charge updates or modifications which directly affect the safe operation of the Goods Abiomed is not obligated to provide updates or modifications which provide a product improvement or enhancement b new product features or c options to the Goods Abiomed has no obligation to provide a loaner system during service or maintenance of the Goods However at Abiomed s sole discretion Abiomed may provide such loaner systems This warranty applies to the Automated Impella Controller and not to any disposable or other component of the Impella System Specific items excluded from this warranty include but are not limited to pumps external tubing and accessories This warranty may not be amended without the express written consent of an authorized officer of Abiomed Impella 2 5 Catheter with the Automated Impella Controller gt 9 9 m 2 i x APPENDIX B ABIOMED APPROVED GUIDEWIRES AND INTRODUCERS ABIOMED APPROVED GUIDEWIRES Use only Abiomed tested and supplied guidewires with the Impella Catheter Guidewires are specifically designed with unique characteristics to optimize performance of the Impella System Guidewires and catheters should always be used in accordance with Abiomed s instructions Table B 1 lists the alternative guidewires that
154. t recently occurring alarm message is displayed at the top of the list For each message the date and time it occurred and the alarm message heading is displayed You can use the selector knob to select individual alarm messages and an explanation for the selected alarm message will be displayed in the failure description box Press EXIT to exit the alarm history analysis e Start Timed Data Recording starts the timed data recording function to save real time operating data for later analysis Timed Data Recording is described under Timed Data Recording in section 6 of this manual Impella 2 5 Catheter with the Automated Impella Controller C 3 Start Repositioning Guide opens the repositioning guide which provides information about the current position of the Impella Catheter and the actions required to reposition the catheter The repositioning guide is described under Repositioning Guide in section 6 of this manual Case Start begins the case procedure Case Start is described in section 5 of this manual under Case Start CA Instructions for Use amp Clinical Reference Manual US APPENDIX D AXILLARY INSERTION TECHNIQUE The Impella Catheter can be inserted surgically through the axillary artery if factors such as scarring or tortuous or diseased vessels preclude femoral insertion This appendix provides an overview of the surgical technique for axillary insertion of the Impella Catheter SUPP
155. tart procedure Console Status No Impella connected Purge cassette not detected Software version V03 10 36 System Power e Y 100 Figure 5 2 Automated Impella Controller Startup Screen The startup screen displays e The current status of the Impella Catheter currently not connected to the Automated Impella Controller in Figure 5 2 e The current status of the purge cassette no purge cassette detected in Figure 5 2 e The current version of the software that the Automated Impella Controller is running The startup screen also displays system power information along the bottom of the screen and two active soft buttons MUTE ALARM and MENU along the right side of the screen 5 4 Instructions for Use Clinical Reference Manual US CASE START Fluoroscopy is required to guide placement of the Impella Catheter The small placement guidewire must be reliably observed at all times The sterile components of the Impella System can be used only if the sterilization indicators show that the contents have been sterilized the packaging is not damaged and the expiration date has not elapsed Avoid manual compression of the inlet and outlet areas of the cannula assembly Do NOT remove the Impella Catheter over the length of the guidewire Handle with care The Impella Catheter can be damaged during removal from packaging preparation insertion and removal Do NOT bend pull or place excess pressur
156. ted Impella Controller The Impella System performs life sustaining functions To use the system you must understand and follow these instructions The Impella System may be used only for its intended purpose 2 2 Jg 2 MANUAL OVERVIEW This manual provides instructions for use of the Impella 2 5 Catheter with the Automated Impella Controller The following summarizes the contents of each section of the manual e Section 1 Warnings and Cautions discusses the warnings and cautions pertaining to the use of the Impella Catheter with the Automated Impella Controller e Section 2 Indications Contraindications and Potential Adverse Events discusses indications for use of the Impella Catheter with the Automated Impella Controller contraindications and potential adverse events that may be associated with the use of the system Section 3 The Impella Catheter and Automated Impella Controller provides an overview of the 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 Using the Automated Impella Controller with the Impella Catheter provides the procedures for using the Impella System Section 6 Patient Management Topics provides key information on various topics related to management of patients with the Impella Catheter and Auto
157. that of a typical commercial or hospital environment Immunity Test Level Level Voltage dips short gt 95 dip for 0 5 gt 95 dip for 0 5 Mains power quality should be interruptions and cycle cycle that of a typical commercial voltage variations 60 dip for 5 cycles 60 dip for 5 cycles 0 a environment If on power supply Bret ur the user of the Automated input lines for 25 ee for 25 Impella Controller requires IEC 61000 4 11 a um continued operation during gt 95 dip for 5 gt 95 dip for 5 power mains interruptions seconds seconds it is recommended that the Automated Impella Controller be powered from an uninterruptible power supply or battery Power Frequency Power frequency magnetic 50 60 Hz Magnetic fields should be that of a Field typical location in a typical IEC 61000 4 8 commercial or hospital environment Instructions for Use amp Clinical Reference Manual US TABLE 203 Guidance Manufacturer s Declaration Emissions Equipment and Systems that are Life Supporting The Automated Impella Controller is intended for use in the electromagnetic environment specified below The customer or user of the Automated Impella Controller should ensure that it is used in such an environment IEC 60601 Compliance Electromagnetic Environment Test Level Level Guidance Portable and mobile RF communications equipment should be separated from the Automated Impella Controller by no less tha
158. the alarm condition are displayed in the right column of the alarm window next to the alarm header and subhead information See section 7 of this manual for further discussion of alarms Catheter serial number Displayed in the upper left of the display screen if a catheter is connected to the controller System date and time The current date DD MM YYYY and time 24 hour format HH MM are displayed in the upper center of the screen display In this example it is June 30 2011 at 5 30am Instructions for Use Clinical Reference Manual US Table 4 3 Automated Impella Controller Display Elements continued Display Element Mute alarm indicator Soft button labels System power area Description Displayed in place of the words MUTE ALARM when an alarm is silenced See section 7 of this manual for more information about the mute alarm function Figure 7 1 illustrates the mute alarm indicator e Yellow bell with red X displayed when an alarm is muted Not displayed when an alarm is active but not muted or when there are no active alarms The soft buttons on the Automated Impella Controller have corresponding labels adjacent to them on the display screen These labels change depending on the type of screen displayed Refer to Appendix this manual for more details about the menu structure MUTE ALARM e Mutes silences active alarms FLOW CONTROL or NEXT FLOW CONTROL Allows you to set the c
159. the course of support with the Impella Catheter the Automated Impella Controller alarms Purge Pressure Low follow the instructions below Inspect the purge system for leaks If there are no leaks change to a purge fluid with a higher dextrose concentration To do this open the PURGE SYSTEM menu and select Change Purge Fluid Follow the instructions on the screen Refer to Purge Cassette Procedures earlier in this section of the manual If the pressure stabilizes no other action is required If the purge pressure is not stable proceed to Step 4 If the low purge pressure alarm remains unresolved for more than 20 minutes there may be a problem with the purge cassette Replace the purge cassette Refer to Change Purge Cassette instructions earlier in this section If the low purge pressure alarm still remains unresolved for more than 20 minutes this may be a sign of Impella Catheter damage Complete the following steps immediately a Open the FLOW CONTROL meter and reduce the flow rate to 0 5 L min b Slowly pull back on the Impella Catheter until it is in the descending aorta approximately 20 cm for an average size patient 1 cm marks are available on the catheter Turn off the Impella Catheter by opening the FLOW CONTROL meter and reducing the flow rate to 0 L min d Disconnect the catheter from the Automated Impella Controller e Remove the Impella Catheter with the use
160. the purge system 1 Press PURGE SYSTEM and select De air Purge System 2 Make sure that the purge fluid bag is NOT empty or inverted and that the tubing is NOT damped Disconnect the purge tubing from the Impella Catheter 4 Press OK to initiate the de air function A progress bar shows the progress of the de air procedure Once complete the system advances to the next screen G 2 2 I m gt m Jg 9 5 A 2 2 m m J I m 9 r rm 5 gt I m E m 5 Confirm that air remains the purge tubing If air remains press BACK to repeat the air removal process 6 Connect the purge tubing to the luer s on the Impella Catheter to complete the de air procedure Impella 2 5 Catheter with the Automated Impella Controller 5 25 Purge Pressure In the initial set up configuration the purge pressure is set to 600 mmHg although it may not reach 600 mmHg in low resistance catheters in this configuration In the standard configuration optimal purge pressure is different for every Impella Catheter Purge pressure can range from 300 mmHg to 1100 mmHg While purge pressure varies during operation the Automated Impella Controller automatically maintains purge pressure within an acceptable range for each Impella Catheter TROUBLESHOOTING THE PURGE SYSTEM LOW PURGE PRESSURE If at any time during
161. to the aortic valve Figure 6 3 Transthoracic Echocardiographic TTE Illustrations of Impella Catheter Position Impella 2 5 Catheter with the Automated Impella Controller 6 9 COLOR DOPPLER ECHOCARDIOGRAPHY When moving a patient supported with an Impella Catheter it is important to monitor catheter migration Adding color Doppler to an echo is another way to verify catheter position If the Impella Catheter is correctly positioned a dense mosaic pattern of turbulence will appear above the aortic valve near the outlet area of the catheter as shown in the top image in Figure 6 4 If however the echocardiogram reveals a dense mosaic pattern of turbulence beneath the aortic valve bottom image in Figure 6 4 this likely indicates that the outlet area of the catheter is in the wrong position that is the catheter is too far into the ventricle or entangled in papillary muscle Note If using transesophageal echocardiography TEE look for the mosaic patterns in the same locations relative to the aortic valve and Impella Catheter outlet area ET et Figure 6 4 Correct and Incorrect Impella Catheter Position Color Doppler TTE 6 10 Instructions for Use amp Clinical Reference Manual US POST INSERTION POSITIONING PIP CHECKLIST Completing the steps shown in the following post insertion positioning checklist can help to ensure proper position of the Impella Catheter following insertion Pay particular attention
162. ts internal battery if the integrity of the protective earth conductor is questionable Lithium ion battery replacement by inadequately trained personnel could result in excessive temperatures fire or explosion Only technicians authorized by Abiomed should remove or change the battery To avoid risk of electric shock this equipment must only be connected to a supply mains with protective earth No modification of this equipment is allowed Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the electromagnetic compatibility EMC information provided in section 8 of this manual During transport the Automated Impella Controller may be exposed to stronger electromagnetic disturbance than during in hospital use Strong electromagnetic disturbance may cause the Automated Impella Controller to display soft button menu selections that were not selected by the user Operators should be aware that under these conditions the operating parameters are not affected No user intervention is required Monitor Impella 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 disturbance Portable and mobile RF communications equipment can affect medical electrical equipment The equipment or system should not be used adjacent to or stacked with other equip
163. uation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people RFID Transmitter Receiver Specifications Frequency 13 56 MHz Receiver bandwidth 14 kHz Effective radiated power 30 nW Modulation ASK SLAVE MONITOR CONNECTION If equipped with a VGA connector the Automated Impella Controller can be connected to a monitor to display the information from the controller to another screen at a resolution of 800 x 600 pixels The connection between the controller and the monitor can be made using a cable up to 20 feet in length Instructions for Use amp Clinical Reference Manual US ALARM DELAY INFORMATION 8 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 Impella Defective 8 second delay Impella Position Wrong 11 5 second delay Controller Error 12 3 second delay Emergency Shutdown Imminent 15 1 second delay Battery Failure 28 8 second delay Controller Failure 38 8 second delay Battery Comm Failure 40 10 second delay 9 m Z m gt lt
164. uide See Patient management Repositioning guide Retrograde flow 4 9 Definition 8 1 Returning an Impella Catheter to Abiomed United States 8 13 Right heart failure See Patient management Right heart failure S Screen brightness Selector knob function 4 3 Set up configuration See Impella System Overview Sodium chloride IV flush solution in pressure bag figure 3 3 Standard configuration See Impella System Overview See Impella System Using the system Startup screen See Controller Startup screen Suction See Patient management Suction Suture pads 3 5 Symbols 8 1 System information C 3 T Target flow Selecting target flow 5 17 figure 5 18 Terminology and abbreviations 8 1 Timed data recording See Patient management Timed data recording Transesophageal echocardiography TEE See Echocardiography Transport between hospitals See Patient management Transport between hospitals Transport within the hospital See Patient management Transport within the hospital Transthoracic echocardiography TTE See Echocardiography Warnings 1 1 Warranty Impella System limited service warranty United States A 1 Waveforms See Impella System Using the system Positioning and starting the catheter Weaning See Impella System Weaning White connector cable See Connector cable X X ray chest 5 12 6 4 Y Y connector See also Purge cassette Compone
165. ure difference between the inlet and outlet areas The scale for the motor current waveform is displayed to the left of the waveform The default scaling is 0 1000 mA It is adjustable in 100 mA increments for the Impella Catheter with a minimum difference between upper and lower limits of 200 mA and a maximum difference of 1000 mA To the right of the waveform is a display that labels the waveform provides the units of measurement 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 purge screen see Figure 4 5 displays purge system data In the central display area of the screen the purge flow rate and purge pressure are plotted as a function of time To the right of the plots the current purge flow rate and purge pressure are displayed Use the DISPLAY soft button to navigate to the purge screen Impella 2 5 S N 123456 FLOW CONTROL 1010 SYSTEM Impella Flow 4 Purge System System Power 2 7 Max 2 5 2 3 Min 1 L min Figure 4 5 Purge Screen mun Purge Flow 7 0 ml hr 100 4 10 Instructions for Use Clinical Reference Manual US PURGE FLOW The purge flow rate delivered by the purge cassette is displayed in mL hr The standard scale for the purge flow 0 30 mL hr is displayed to the left of the purge flow plot The maximum value on this scale can b
166. urrent flow rate for the Impella Catheter e NEXT Advances to the next screen DISPLAY or BACK DISPLAY Brings up the Display menu for viewing waveforms and navigating to other screen displays e BACK Returns to the previous screen PURGE SYSTEM or EXIT PURGE SYSTEM Brings up the Purge System menu for changing the purge fluid purge cassette or purge system de airing the purge system or transferring to the standard configuration e EXIT Exits the current procedure MENU or Exit Repositioning Guide MENU Brings up a menu of options related to controller settings alarm history repositioning and starting a case e Exit Repositioning Guide Exits the repositioning guide System power information is displayed to the right of the purge system information on the bottom of the display screen Battery status Bar within battery symbol indicates the overall remaining capacity of the batteries e Full green bar for fully charged battery e Partial green bar for battery that is at least 50 charged e Partial yellow bar for battery that is between 16 and 50 charged e Partial red bar for battery that is less than or equal to 15 charged e Moving gray bar for battery that is in charging mode e Numeric percentage of battery power remaining displayed below the battery icon AC plug indicator e Green plug indicates that the controller is running on AC power Gray plug with a red X indicates no AC power
167. vents bacterial contamination and air from entering the purge lumen Pressure reservoir The pressure reservoir includes a flexible rubber diaphragm that provides additional filling volume by means of an expansion chamber during purge solution change Check valve The yellow check valve ensures that purge fluid does not flow in the reverse direction when the purge solution is exchanged Impella 2 5 Catheter with the Automated Impella Controller 3 5 AUTOMATED IMPELLA CONTROLLER The Automated Impella Controller see Figure 3 5 provides three vital functions to the operation of the Impella Catheter Controller Battery Power D e The controller provides an interface for monitoring and controlling the function of the The controller can operate Impella Catheter on its internal lithium ion e The controller provides a fluid purge to the Impella Catheter Li lon battery for at least 60 minutes when fully charged The controller provides backup power when the Impella System is operated away from AC power The controller weighs 26 lbs 11 8 kg and can operate on its internal battery for at least 60 minutes when fully charged Automated Impella Controller operation is described in detail in section 4 of this manual Impella Controller Figure 3 5 Automated Impella Controller Front View 3 6 Instructions for Use amp Clinical Reference Manual US PURGE CASSETTE Do not use saline in the pur
168. x Min displays the range for the flow rate Current flow rate e Mean catheter flow displayed in liters per minute L min the numbers appear in white if the catheter position is correct yellow if the catheter position is incorrect or unknown e f the system is unable to calculate flow a yellow triangular caution icon is displayed with the message Flow Calculation Disabled Catheter operation icon e The circular catheter operation icon rotates when the Impella Catheter is running On the home screen the central display area displays a heart pictogram and Impella Catheter position indicator message Heart pictogram appears in the center of the home screen display e Provides a visual representation of the current Impella Catheter position e Overlaid with a translucent yellow 7 when the controller detects an incorrect catheter position or cannot determine catheter position Impella Catheter position indicator message displayed to the left of the heart icon e Displays Impella Position OK in green when catheter position is correct e Displays Impella Position Unknown in yellow when catheter position is unknown e Displays Impella Position in Ventricle in yellow when catheter is in the ventricle e Displays Impella Position Wrong in yellow when catheter position is incorrect e Displays Placement Monitoring Suspended in yellow when there is a fault in the sensor e Displays
169. xtrose FLOW Infusion CONTROL Infusion Time Period Volume ml Heparin U Dextrose mg 30 06 2011 16 00 16 30 10 2000 4000 30 2011 15 00 16 00 20 4000 ET 2011 14 00 15 00 2011 13 00 14 00 Concentration M E Heparin Infusion 30 06 2011 12 00 13 00 units hr 30 06 2011 11 00 12 00 ET 2011 10 00 11 00 1000 Concentration 30 06 2011 09 00 10 00 50 units ml IN mpak Flow 4 Purge System _ System Power 2 7 Max 2 3 Min 2 5 L min Purge Flow 20 0 ml hr 100 Figure 4 6 Infusion History Screen MOBILE OPERATION The Li lon 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 the Automated Impella Controller will operate for at least 60 minutes after the batteries have been fully charged The Automated Impella Controller can be operated on internal battery power when it is not connected to AC power 1 Disconnect the Automated Impella Controller from AC power 2 The Automated Impella Controller beeps once every 5 minutes to alert you that it is running on battery power and a white advisory notification appears in the alarms area on the screen The AC power icon turns gray with an X through it 3 When the Automated Impella

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