Abbott CentriMag Operation Manual
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Abbott CentriMag Operation Manual

Circulatory support system
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CentriMag
READ ALL INDIVIDUAL CENTRIMAG CIRCULATORY SUPPORT SYSTEM
COMPONENT INSTRUCTIONS FOR USE (IFU), THE CENTRIMAG CLINICAL
REFERENCE MANUAL, AND THE ENTIRE CONTENTS OF THIS MANUAL
Abbott Medical Clinical & Technical Support Phone number(s)
Emergency HeartLine™ Support:
Abbott Medical
Main Switchboard:
Manufacturer:
Thoratec Switzerland GmbH
Technoparkstrasse 1
CH-8005 Zürich
Switzerland
TM
CentriMag
Circulatory Support System Operation Manual (US)
© 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
TM
Circulatory Support System
Operation Manual
BEFORE USE.
Tel: +1-800-456-1477
Tel: +1-925-847-8600
Fax: +1-925-847-8574
US Headquarters:
Abbott Medical
6035 Stoneridge Drive
Pleasanton, CA 94588
USA
www.abbott.com
PL-0047, Rev 11
December 2019
DCO No 19-038
Page 1 of 126

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  • Page 1 6035 Stoneridge Drive CH-8005 Zürich Pleasanton, CA 94588 Switzerland www.abbott.com PL-0047, Rev 11 December 2019 DCO No 19-038 CentriMag Circulatory Support System Operation Manual (US) Page 1 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 2: Table Of Contents

    Power Assembly ....................49 6.10 Requirements for Connecting Additional Equipment ......... 49 SETTING UP THE SYSTEM ................. 50 CentriMag Circulatory Support System Operation Manual (US) Page 2 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 3 Accessing the Monitor Management Application ..........84 7.26 Pump Set-up ....................85 SYSTEM OPERATION .................. 86 Operation of the Pump ..................86 CentriMag Circulatory Support System Operation Manual (US) Page 3 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 4 Appendix II – Technical Specification ............. 118 12.3 Appendix III – Electromagnetic Emissions ............122 12.4 Appendix IV – Electromagnetic Immunity ............123 CentriMag Circulatory Support System Operation Manual (US) Page 4 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 5: Manual Overview

    1 MANUAL OVERVIEW This manual provides technical information and use instructions for the CentriMag Circulatory Support System (System). The Clinical Reference Manual contains clinical use information on the System to help guide healthcare professionals. The user must understand and follow both manuals. The following summarizes the content of each section of this manual.

  • Page 6: Indications And Contraindications

    Federal law to Federal law to CentriMag Circulatory Support System Operation Manual (US) Page 6 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 7 PediMag Blood PL-0112, PediMag Federal (U.S.A.) law The PediMag Blood CentriMag Circulatory Support System Operation Manual (US) Page 7 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 8 K110980 an extracorporeal CentriMag Circulatory Support System Operation Manual (US) Page 8 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 9: Contraindications For Use

    The System is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative. CentriMag Circulatory Support System Operation Manual (US) Page 9 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 10: General Conventions

    3.2 Patents and Trademarks Patents: One or more patents or published applications cover this product and its use. Trademarks: ™ Indicates a trademark of the Abbott group of companies. ‡ Indicates a third party trademark, which is property of its respective owner.

  • Page 11: Warnings And Precautions

    4 WARNINGS AND PRECAUTIONS WARNING Read this entire manual before you use the CentriMag System. As with all prescription medical devices, clinical procedures should be conducted under the direction of the prescribing physician. The physician must be trained on the use of the System before using it.
  • Page 12 WARNING Only use parts supplied by Abbott Medical. Do not modify the System in any way as there are no safety or performance data that establish compatibility with any other manufacturer’s device or components. Use of any other component may result in a sudden Motor stop.

  • Page 13: Description

    PediMag Blood Pump, CentriMag Console, Motor, Mag Monitor, Flow Probe, cannulas, and a second system as a backup. Standard medical grade use tubing is not provided. You can use the Console and Monitor with both of the Pumps. For each Pump, the Console is operated in an identical manner and has the same Console display, alarms, and alerts.
  • Page 14 Figure 2: PediMag Blood Pump CentriMag Circulatory Support System Operation Manual (US) Page 14 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 15 Figure 3: CentriMag Motor CentriMag Circulatory Support System Operation Manual (US) Page 15 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 16 Figure 4: 2 Generation CentriMag Primary Console CentriMag Circulatory Support System Operation Manual (US) Page 16 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 17 Figure 5: Mag Monitor CentriMag Circulatory Support System Operation Manual (US) Page 17 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 18 Figure 6: Flow Probe CentriMag Circulatory Support System Operation Manual (US) Page 18 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 19 Pediatric Flow Probe) 5.1.2 Optional CentriMag Circulatory Support System Components The following components are available as optional accessories for the System (Table 2): Table 2: Optional Elements for the CentriMag and PediMag Systems System Component Image System Cart Motor Bracket...
  • Page 20 Table 2: Optional Elements for the CentriMag and PediMag Systems System Component Image Monitor Arm Monitor Clamp Console Standoff CM Distance Holder Pressure Transducer Cables CentriMag Circulatory Support System Operation Manual (US) Page 20 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 21 Table 2: Optional Elements for the CentriMag and PediMag Systems System Component Image (picture for reference only) Pressure Transducers (picture for reference only) 5.1.3 CentriMag and PediMag Blood Pumps The CentriMag and PediMag Blood Pumps are electronically-driven, centrifugal Pumps based on bearingless motor technology. The centrifugal Pump allows pumping without mechanical bearings and seals.
  • Page 22 Figure 8: Axial support (a) and stabilization against tilting (b) of the impeller by passive magnetic forces in the Pump CentriMag Circulatory Support System Operation Manual (US) Page 22 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 23 Table 3: The System with and without the Monitor summarizes the differences between the System with and without the Monitor. CentriMag Circulatory Support System Operation Manual (US) Page 23 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 24 The Monitor provides an additional RS232 port on the back panel as shown in Figure 9. The RS232 port provides a live data stream. For additional information, contact your local Abbott Medical representative. Do not use the RS232 port without contacting your local Abbott Medical representative.
  • Page 25 USB Port (Strictly for downloading Ethernet Port data to a RS232 Port Memory Stick) Figure 9: Monitor Back Panel CentriMag Circulatory Support System Operation Manual (US) Page 25 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 26 5.1.5 2 Generation CentriMag Primary Console The Console uses single-phase AC power when used with the CentriMag Pump. The Pump is capable of a flow rate of up to 10.0 LPM or maximum pressure head of 600 mmHg. Flows up to 1.5 LPM or a maximum pressure head of 540 mmHg may be generated with the PediMag Pump and circuit.
  • Page 27 PVC tubing with 3/32” wall thickness. Both probes incorporate a molded clip-on design for easy care and handling. CentriMag Circulatory Support System Operation Manual (US) Page 27 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 28 Product Reference AC Power Connector Flow Probe Equipotential Number Number and Fuse Connector Bonding Post Figure 12: Back Panel CentriMag Circulatory Support System Operation Manual (US) Page 28 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 29 (RPM), the extracorporeal circuit resistance, and drainage and return blood pressures. The relationship between pressure and flow rate as a function of RPM can be seen in Figure 14 for the CentriMag Pump as an isolated component. Figure 14: CentriMag Pump Differential Pressure/Flow (H-Q) Curve Refer to the CentriMag and PediMag pump IFUs for additional information.
  • Page 30 Figure 15: CentriMag Motor 5.1.8 Backup Console The 2 Generation CentriMag Console is also designed for use as a backup Console. The intended function of the backup Console is to provide basic life-support in the event of a main Console malfunction. CentriMag...
  • Page 31 5.1.9 System Cart The Console and the Monitor are designed to be used with a custom designed CentriMag System Cart. The System Cart and an example of placement of components are shown in Figure 16. Figure 16: System Cart, main and backup Consoles, Monitor, and Motors.

  • Page 32: Required User Supplied Items

    More detailed information regarding the software version can be found in Section 12.2. 5.2 Required User Supplied Items The following items, required for use with the CentriMag System, are not provided by Abbott Medical: • Smooth jawed tubing clamps •...

  • Page 33: Specifications And General Description

    Motor enclosure. Not suitable for use in an oxygen None Not for oxygen rich environment rich environment. CentriMag Circulatory Support System Operation Manual (US) Page 33 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 34: Specifications

    Note: If the probe detects forward flow of more than 10 LPM then it will display as “^^.^^ LPM”. CentriMag Circulatory Support System Operation Manual (US) Page 34 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 35: Essential Performance

    (LPM), and pressure measurements (mmHg). The top two lines of Row 2 on the display are used to display System status. The bottom line displays the four soft keypad CentriMag Circulatory Support System Operation Manual (US) Page 35 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 36 Console, and vice versa. It is possible to control the System using the Console front panel or the Monitor soft keypads when the Monitor is connected to the Console. CentriMag Circulatory Support System Operation Manual (US) Page 36 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 37 Figure 18: Monitor CentriMag Circulatory Support System Operation Manual (US) Page 37 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 38 This keypad is used to select/modify Front Panel Decrease the value for the displayed item to be On the Monitor’s adjusted. Front Panel CentriMag Circulatory Support System Operation Manual (US) Page 38 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 39 LPM. Markers show the current settings of the Maximum and Minimum flow limits. CentriMag Circulatory Support System Operation Manual (US) Page 39 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 40 On the Console’s Connector connector facilitates alignment of Back Panel the Motor LEMO connector. CentriMag Circulatory Support System Operation Manual (US) Page 40 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 41 On the Console’s Monitor Back Panel and (CAN/12V) Connection for the Monitor Monitor’s Back Connector Panel (2 sockets) CentriMag Circulatory Support System Operation Manual (US) Page 41 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 42 2 The RS232 port is disabled and intended for future use in the US. 3 The Ethernet port is disabled and intended for future use in the US. CentriMag Circulatory Support System Operation Manual (US) Page 42 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 43 Consult the CentriMag Circulatory On the serial Read Manual Support System Operation Manual number label before operating the device. CentriMag Circulatory Support System Operation Manual (US) Page 43 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 44 Back Panel main System. Monitor Serial Number Label On the Monitor’s Back Panel CentriMag Circulatory Support System Operation Manual (US) Page 44 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 45 Near the top joint crush and cut. Do not place hand on Crush of the Monitor Arm or into joint area. CentriMag Circulatory Support System Operation Manual (US) Page 45 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 46 ALARM ACKNOWLEDGE keypad mutes the audio alert indication and removes the visual alarm/alert message. CentriMag Circulatory Support System Operation Manual (US) Page 46 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 47 Pump will continue to operate, but additional attention and/or corrective action may be necessary to resolve the alert condition. CentriMag Circulatory Support System Operation Manual (US) Page 47 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 48 IEC 60601-1. If in doubt, consult your local Abbott Medical representative prior to connecting any accessory to the System. CentriMag Circulatory Support System Operation Manual (US) Page 48 of 126 ©...

  • Page 49: Digital Display Information

    If in doubt, consult your local representative or the technical service department. CentriMag Circulatory Support System Operation Manual (US) Page 49 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 50: Setting Up The System

    Note: If the probe detects forward flow of more than 10 LPM then it will display as “^^.^^ LPM”. Last state: the value/state carried from the last operational use of the 2 Generation CentriMag Console. CentriMag Circulatory Support System Operation Manual (US) Page 50 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 51: Abbott – Document No Pl-0047, Rev 11 (December

    Retain all packaging materials in the event that the Console or any other component needs to be returned to Abbott Medical for repair or maintenance. WARNING Never put containers of liquids on top of or in the immediate vicinity of the Console.

  • Page 52: Console Mounting

    Console Standoff to securely fix both Consoles in place. Figure 20: Combination of Distance Holder and Console Standoff CentriMag Circulatory Support System Operation Manual (US) Page 52 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 53: Monitor Mounting

    This can be achieved with the Monitor Arm provided by Abbott Medical and Ergotron. The Monitor Arm can be mounted either on the edge of a horizontal or vertical solid surface or on a vertical pole.
  • Page 54 Monitor, see Figure 24. Make sure the screws are sufficiently tightened. CentriMag Circulatory Support System Operation Manual (US) Page 54 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 55 (LX Wall Mount LCD ARM) which is included in the Monitor Arm packaging. Figure 26 shows the complete Monitor assembly. CentriMag Circulatory Support System Operation Manual (US) Page 55 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 56 Moving parts of the Monitor Arm can crush and cut causing severe injury. Do not place hand on or into joint area. Figure 27: Hand Crush Warning on Monitor Arm CentriMag Circulatory Support System Operation Manual (US) Page 56 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 57: Motor Mounting

    7.4 Motor Mounting It is crucial that the Motor is securely fixed to a solid object. This can be achieved with the Motor Bracket provided by Abbott Medical. The Motor Bracket can be mounted on a vertical pole. 7.4.1 Steps required to setup the Motor Bracket and the Motor: 1.
  • Page 58 Motor. Make sure the screws are sufficiently tightened. Figure 30: Completely assembled Monitor Bracket with Motor CentriMag Circulatory Support System Operation Manual (US) Page 58 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 59: Powering Up The Console

    In the BVAD configuration, both Console power cords must be inserted directly into an AC wall outlet. CentriMag Circulatory Support System Operation Manual (US) Page 59 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 60 Figure 31: Correct Biventricular Assist Power Connection CentriMag Circulatory Support System Operation Manual (US) Page 60 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 61 Figure 32: Incorrect Biventricular Assist Power Connection WARNING To avoid the risk of electric shock, the CentriMag equipment must only be connected to a mains supply with a protective earth. Insert the LEMO connector on the Motor cable into the Motor connection on the rear of the Console.

  • Page 62: Self-Test Initiation

    WARNING Use of Flow Probes from sources other than Abbott Medical is not recommended. Flow probes that are not obtained from Abbott Medical may not function, may cause the Console to malfunction, or may lead to missing or inaccurate flow information.

  • Page 63: Configuring The Console

    Monitor as well as on the Console’s user interface (Figure 34). Figure 33: Monitor – Front Panel CentriMag Circulatory Support System Operation Manual (US) Page 63 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 64 - SUPPORT TYPE - LANGUAGE SELECTION - DATA LOGGER (Monitor only) - COPY DATA (Monitor only) - MANAGEMENT (Monitor only) CentriMag Circulatory Support System Operation Manual (US) Page 64 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 65: Console Bios

    BIOS. 3) SERIAL NUMBER / SOFTWARE VERSION (FOR SERVICE PURPOSE ONLY) CentriMag Circulatory Support System Operation Manual (US) Page 65 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 66: Setting The Console Max Flow Alert

    If the System detects flow in excess of 10 LPM, the digital flow display will not display a numerical flow, but will display upwards pointing arrows: “^^.^^ LPM” CentriMag Circulatory Support System Operation Manual (US) Page 66 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 67: Setting The Console Min Flow Alert

    During weaning and periods of sustained low flow it may be necessary to reevaluate and consider increasing the level of anticoagulation. Refer to the Clinical Reference Manual for details. CentriMag Circulatory Support System Operation Manual (US) Page 67 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 68: Entering The Pressure Menu

    Increase Figure 39: Monitor MENU Structure Setting the Max or Min Pressure Alert Settings for the P1 Transducer CentriMag Circulatory Support System Operation Manual (US) Page 68 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 69: Setting The Max Or Min Pressure Alert Settings For The P2 Transducer

    If there is a failure to obtain pressure data confirm that the pressure transducer and cable connection are fully seated. Additional troubleshooting may include recalibrating, or disconnecting and reconnecting the connections. CentriMag Circulatory Support System Operation Manual (US) Page 69 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 70 3. Depress the MENU keypad to display PRESSURE MENU, and then select PRESSURE CALIBRATION in order to calibrate the Pressure Probe(s) using the following method. CentriMag Circulatory Support System Operation Manual (US) Page 70 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 71 C. The pressure monitoring system is now ready for use. CentriMag Circulatory Support System Operation Manual (US) Page 71 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 72: Stopwatches

    STOP button. Once the timer has been stopped, the System will offer the option to RESET, which will clear the timer. CentriMag Circulatory Support System Operation Manual (US) Page 72 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 73: Flow Range

    MENU option is displayed, then use the MENU key to scroll through the menu options until the FLOW RANGE option is displayed. Select between the two options using the arrow keys. CentriMag Circulatory Support System Operation Manual (US) Page 73 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 74: Changing The Flow Recorder Speed

    MENU option is displayed and then use the MENU key to scroll through the menu options until the RECORDER SPEED option is displayed. Select between the two available options using the arrow keys. CentriMag Circulatory Support System Operation Manual (US) Page 74 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 75: Setting The Console Speed Step Resolution

    Pump will increase with each depression of the UP or DOWN ARROW keypads when using the SET RPM option. CentriMag Circulatory Support System Operation Manual (US) Page 75 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 76: Selecting Displayed Language

    The language selected will be stored in permanent memory by the Console and recalled each time the Console is powered up. CentriMag Circulatory Support System Operation Manual (US) Page 76 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 77: Setting The Console Flow Limit Sensitivity

    SENSITIVE mode than the NORMAL mode. CentriMag Circulatory Support System Operation Manual (US) Page 77 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 78: Setting The Application Mode

    Identification of each Console allows an easy differentiation in case the System is used in a bilateral configuration. CentriMag Circulatory Support System Operation Manual (US) Page 78 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 79: The System Data Logger

    The System data logger allows users to view a log of significant events that have occurred since the System was powered up. Each logged event follows the format shown in the figure below. CentriMag Circulatory Support System Operation Manual (US) Page 79 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 80 This event is generated when the “Alarm Alert acknowledged Acknowledge” button is pressed and an alert is still active. CentriMag Circulatory Support System Operation Manual (US) Page 80 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 81 CentriMag Circulatory Support System Operation Manual (US) Page 81 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 82: Copy Logger Data To A Usb Memory Stick

    (e.g. Mag Log Converter). The Logger Data is stored on the USB Memory Stick in the “log” folder. CentriMag Circulatory Support System Operation Manual (US) Page 82 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 83: Monitor Connection

    Operating the Monitor while the Console runs on battery shortens the battery runtime. Refer to the individual RVAD or LVAD Console display when the Monitor is not in use. CentriMag Circulatory Support System Operation Manual (US) Page 83 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 84: Accessing The Monitor Management Application

    MENU key (selection) and UP key (increase) or DOWN key (decrease). CentriMag Circulatory Support System Operation Manual (US) Page 84 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 85: Pump Set-Up

    4) Data Logger View Mode Setting: Always “Normal” 5) Application Software Version 7.26 Pump Set-up Refer to the CentriMag and PediMag Pump Instructions for Use for proper setup and operation of the Pumps. WARNING Always fully unscrew the Pump retaining screw built into the Motor before inserting and locking the Pump in the Motor receptacle.

  • Page 86: System Operation

    UP arrow on the Monitor and the DOWN arrow on the Console, will result in no change in the Console, consistent with no input. CentriMag Circulatory Support System Operation Manual (US) Page 86 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 87: Abbott – Document No Pl-0047, Rev 11 (December

    Pump, circuit, and Cannulas. CentriMag Circulatory Support System Operation Manual (US) Page 87 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 88 4. Slowly increase the RPM until the flow rate is at the desired level. The RPM and LPM will be displayed on the Console. CentriMag Circulatory Support System Operation Manual (US) Page 88 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 89: Console Alarm/Alert Strategy

    Table 13 or Table 16 to determine the appropriate operator response for the specific Alert/Alarm which has occurred. CentriMag Circulatory Support System Operation Manual (US) Page 89 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 90 PRESSURE 2 DISCONNECTED message remains) When applicable, audio tone will reactivate if the condition persists during time lapse. CentriMag Circulatory Support System Operation Manual (US) Page 90 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 91: Alarms

    Pump to backup equipment. Always unclamp the tubing prior to resumption of pumping. CentriMag Circulatory Support System Operation Manual (US) Page 91 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 92 An alert is an advisory that a System operating parameter is approaching or has produced an undesirable operating condition. An alert is sounded. and the alert CentriMag Circulatory Support System Operation Manual (US) Page 92 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 93 An audible alarm will sound, which can be muted for 60 Alarm MOTOR STOPPED seconds. Clamp the return tubing and switch to the backup Console, CentriMag Circulatory Support System Operation Manual (US) Page 93 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 94 Switch to the backup Console, Motor and Flow Probe according the procedure described in Section 10.1. Resume support. Record the alarm message and contact your Abbott CentriMag Circulatory Support System Operation Manual (US) Page 94 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 95 Alert Ensure appropriate pressure alarms are set. Consider MINIMUM recalibrating the transducer if alert cannot be explained by CentriMag Circulatory Support System Operation Manual (US) Page 95 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 96: Battery Operation

    If a power failure causes loss of AC power or patient transport is necessary, a new fully charged internal battery will operate the Console for approximately 120 minutes at 5.5 LPM and 3,500 RPM when used with the CentriMag CentriMag...
  • Page 97 ON BATTERY message is cleared, the green AC indicator is illuminated and the green battery indicator is no longer illuminated. CentriMag Circulatory Support System Operation Manual (US) Page 97 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 98 Console must be connected to AC Power to charge or maintain the battery charge, but does not need to be powered ON. CentriMag Circulatory Support System Operation Manual (US) Page 98 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 99: Operation Of The Centrimag Circulatory Support System On Internal Console Battery Power

    Consoles need to have fully charged internal batteries before mains power is disconnected from the System. In the event the duration of the patient transit is longer than expected, operate the CentriMag Motor and Pump with the backup Console. 8.5.2 Changing from the Main to the backup Console When the charge level of the main Console’s internal battery reaches a pre-set minimum...

  • Page 100: Patient Transport

    Console. The 2 Generation CentriMag Console may be connected to the CentriMag System Transporter (Figure 54) for ground vehicle or aircraft transport, or placed on a Cart (Figure 16) for intra-hospital transport. Figure 54: CentriMag...

  • Page 101: Shut Down By Operator

    Console remain powered. Turn the Console OFF and unplug the Console from the Mains to completely turn OFF power to the Console. CentriMag Circulatory Support System Operation Manual (US) Page 101 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 102 Console is not charged prior its use, the battery may not have sufficient power to operate the System and the support time will be shorter than if it had been charged. CentriMag Circulatory Support System Operation Manual (US) Page 102 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 103: Maintenance

    Instructions on how to change the fuses, maintain the Console, and visually inspect the Motor cable for damage are provided below. WARNING The Console is serviceable (e.g. opening of the housing) only by a Abbott Medical service representative or Abbott Medical authorized representative. 9.1 Changing Fuses CAUTION The Console must be unplugged from AC power source while replacing fuses.

  • Page 104: Recommended Preventive Maintenance

    AC powered storage as it may overheat and malfunction. 9.3 Recommended Preventive Maintenance The services listed in Table 15 are applicable to the main and backup Consoles and should be performed by qualified personnel trained by Abbott Medical. These maintenance processes are only to be performed off-patient. WARNING Perform routine battery maintenance by following the preventive maintenance schedule in order to confirm proper calibration of the “battery charge...

  • Page 105: Battery Maintenance

    To ensure proper operation and patient safety, only Abbott Medical-approved spare parts must be used to maintain this device. The user may NOT replace the internal battery without proper training by Abbott Medical or its distributor. Please request assistance by calling Abbott Medical Customer Service if the internal battery requires replacement.

  • Page 106: Motor Visual Inspection

    Motor Connector Cable Motor Body Figure 55: CentriMag Motor 1) Visually inspect the CentriMag Motor connector for bent or broken pins. Check for burn marks or melted plastic. Figure 56: Motor Connector Pin View CentriMag Circulatory Support System Operation Manual (US) Page 106 of 126 ©...
  • Page 107 Note: If there are any issues while connecting the CentriMag Motor to the CentriMag Console, inspect the Motor port on the rear of the Console for damage, particularly for any broken pins that may be lodged inside. 2) Visually inspect the entire length of the CentriMag Motor cable, including both bend reliefs (see Figures 57 and 58), for any damage such as separations of the bend reliefs, deformations, kinks, or cuts.
  • Page 108 Figure 60: Undamaged and Intact Motor Cable Figure 61: Damaged Motor Cable Figure 62: Damaged Motor Cable CentriMag Circulatory Support System Operation Manual (US) Page 108 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)

  • Page 109: Emergency / Troubleshooting

    If the retaining screw is not visible in a notch, loosen the retaining screw, remove the pump, remount, rotate the Pump counterclockwise, and secure by advancing the retaining screw. CentriMag Circulatory Support System Operation Manual (US) Page 109 of 126 © 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
  • Page 110 OFF. The battery for the backup Console must be periodically assessed according to section 9.3 and 9.4. CentriMag Circulatory Support System Operation Manual (US) Page 110 of 126 © 2019 Abbott– Document No PL-0047, Rev 11 (December 2019)

  • Page 111: Switching To Another Pump

    Motor housing. Clamp the return tubing and switch to the backup System according to the procedure described in Section 10.1. Resume support. Record the alarm message and contact your local Abbott Medical representative. WARNING Always fully unscrew the Pump retaining screw built into the Motor before inserting and locking the Pump in the Motor receptacle.

  • Page 112: Electrosurgical Units

    Under rare conditions, this might cause Console and/or Monitor display flickers while the ESU is activated. If the System is used concurrently with an Electrosurgery unit, Abbott Medical recommends that the user should read and follow the electrocautery manufacturer’s instructions for prevention of interference with other electronic devices.

  • Page 113: Disposal Of Equipment

    Please act according to your local rules and do not treat electronic waste as normal household waste. Proper disposal of electronic waste helps prevent potential negative consequences for the environment and human health. CentriMag Circulatory Support System Operation Manual (US) Page 113 of 126 © 2019 Abbott– Document No PL-0047, Rev 11 (December 2019)

  • Page 114: Appendices

    If the alarm repeats, switch to backup Console, Motor and Flow Probe according the procedure described in Section 10.1. CentriMag Circulatory Support System Operation Manual (US) Page 114 of 126 © 2019 Abbott– Document No PL-0047, Rev 11 (December 2019)
  • Page 115 SYSTEM ALERT procedure described in Section 10.1. Resume support. Record the alarm message and contact your local Abbott Medical representative. CentriMag Circulatory Support System Operation Manual (US) Page 115 of 126 © 2019 Abbott– Document No PL-0047, Rev 11 (December 2019)
  • Page 116 Section 10.1. Verify that the backup Motor stands free and is not covered (e.g. blankets). CentriMag Circulatory Support System Operation Manual (US) Page 116 of 126 © 2019 Abbott– Document No PL-0047, Rev 11 (December 2019)
  • Page 117 Alert ON BATTERY while using the System on battery. Re-connect to AC-outlet, as soon as possible. CentriMag Circulatory Support System Operation Manual (US) Page 117 of 126 © 2019 Abbott– Document No PL-0047, Rev 11 (December 2019)

  • Page 118: Appendix Ii - Technical Specification

    Rev 00 Generation CentriMag Console Application IFD: SW-0033-01 Rev 02 Software SPS-MSP: SW-0034-01 Rev 02 SPS-PIC: SW-0043-01 Rev 00 CentriMag Circulatory Support System Operation Manual (US) Page 118 of 126 © 2019 Abbott– Document No PL-0047, Rev 11 (December 2019)
  • Page 119 Software CPLD: SW-0061-01 Rev 01 Max. Product Life 5 years Use only USB-compatible Memory Sticks USB Port (FAT/FAT32 formatted) CentriMag Circulatory Support System Operation Manual (US) Page 119 of 126 © 2019 Abbott– Document No PL-0047, Rev 11 (December 2019)
  • Page 120 14.3 mm (9/16”) Material Polyvinyl Chloride Calibrated for Fluid Blood at 37 ºC Temperature (ºC) Probe Calibration Tubing Type Tygon S-50-HL CentriMag Circulatory Support System Operation Manual (US) Page 120 of 126 © 2019 Abbott– Document No PL-0047, Rev 11 (December 2019)
  • Page 121 11.1 mm (7/16”) Material Polyvinyl Chloride Calibrated for Fluid Blood at 37 ºC Temperature (ºC) Probe Calibration Tubing Type Tygon S-50-HL CentriMag Circulatory Support System Operation Manual (US) Page 121 of 126 © 2019 Abbott– Document No PL-0047, Rev 11 (December 2019)

  • Page 122: Appendix Iii - Electromagnetic Emissions

    The CentriMag Circulatory Support System with 2 Generation CentriMag Console and Mag Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the CentriMag Circulatory Support System should assure that it is used in such an environment.

  • Page 123: Appendix Iv - Electromagnetic Immunity

    Guidance and manufacturer’s declaration – electromagnetic immunity The CentriMag Circulatory Support System with 2 Generation CentriMag Console and Mag Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the System should assure that it is used in such an environment.

  • Page 124: Abbott – Document No Pl-0047, Rev 11 (December

    Guidance and manufacturer’s declaration – electromagnetic immunity The CentriMag Circulatory Support System with 2 Generation CentriMag Console and Mag Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the System should assure that it is used in such an environment.
  • Page 125 Guidance and manufacturer’s declaration – electromagnetic immunity The CentriMag Circulatory Support System with 2 Generation CentriMag Console and Mag Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the System should assure that it is used in such an environment.
  • Page 126 CentriMag Circulatory Support System The CentriMag Circulatory Support System with 2 Generation CentriMag Console and Mag Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of...

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