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CentriMag

Circulatory Support System Operation Manual (US)

Page 2 of 126

TABLE OF CONTENTS

MANUAL OVERVIEW .....................................................................................5

INDICATIONS AND CONTRAINDICATIONS .................................................6

2.1

Indications for Use .............................................................................................. 6

2.2

Contraindications for Use ................................................................................... 9

GENERAL CONVENTIONS .......................................................................... 10

3.1

Warnings and Cautions .................................................................................... 10

3.2

Patents and Trademarks .................................................................................. 10

3.3

Conventions Used in This Manual .................................................................... 10

WARNINGS AND PRECAUTIONS ............................................................... 11

DESCRIPTION .............................................................................................. 13

5.1

General Overview ............................................................................................. 13

5.2

Required User Supplied Items .......................................................................... 32

SPECIFICATIONS AND GENERAL DESCRIPTION .................................... 33

6.1

Classification .................................................................................................... 33

6.2

Specifications ................................................................................................... 34

6.3

Environmental Conditions ................................................................................. 34

6.4

Essential Performance ..................................................................................... 35

6.5

EMI Considerations .......................................................................................... 35

6.6

Permanent Magnet Considerations .................................................................. 35

6.7

Operator Controls ............................................................................................. 35

6.8

Digital Display Information ................................................................................ 49

6.9

Power Assembly ............................................................................................... 49

6.10

Requirements for Connecting Additional Equipment ......................................... 49

SETTING UP THE SYSTEM ......................................................................... 50

Summary of Contents for CentriMag

Page 1: ...CENTRIMAG CLINICAL REFERENCE MANUAL AND THE ENTIRE CONTENTS OF THIS MANUAL BEFORE USE Abbott Medical Clinical Technical Support Phone number s Emergency HeartLine Support Abbott Medical Main Switchboard Tel 1 800 456 1477 Tel 1 925 847 8600 Fax 1 925 847 8574 Manufacturer Thoratec Switzerland GmbH Technoparkstrasse 1 CH 8005 Zürich Switzerland US Headquarters Abbott Medical 6035 Stoneridge Drive P...

Page 2: ...emarks 10 3 3 Conventions Used in This Manual 10 4 WARNINGS AND PRECAUTIONS 11 5 DESCRIPTION 13 5 1 General Overview 13 5 2 Required User Supplied Items 32 6 SPECIFICATIONS AND GENERAL DESCRIPTION 33 6 1 Classification 33 6 2 Specifications 34 6 3 Environmental Conditions 34 6 4 Essential Performance 35 6 5 EMI Considerations 35 6 6 Permanent Magnet Considerations 35 6 7 Operator Controls 35 6 8 D...

Page 3: ...essure Alert Settings for the P1 Transducer 68 7 13 Setting the Max or Min Pressure Alert Settings for the P2 Transducer 69 7 14 Activating the Pressure Monitoring System Pressure Display 69 7 15 Stopwatches 72 7 16 Flow range 73 7 17 Changing the flow recorder speed 74 7 18 Setting the Console Speed Step Resolution 75 7 19 Selecting Displayed Language 76 7 20 Setting the Console flow limit sensit...

Page 4: ... Changing Fuses 103 9 2 Maintenance Following Each Patient Use 103 9 3 Recommended Preventive Maintenance 104 9 4 Battery Maintenance 105 9 5 Motor Visual Inspection 106 10 EMERGENCY TROUBLESHOOTING 109 10 1 Switching to Backup Hardware 109 10 2 Switching to another Pump 111 10 3 Defibrillation Cardioversion 111 10 4 Electrosurgical Units 112 11 DISPOSAL OF EQUIPMENT 113 12 APPENDICES 114 12 1 App...

Page 5: ... Specifications and General Description describes the product specifications and physical attributes of the System Section 7 Setting up the System describes the procedure for unpacking the System and configuring it for use Section 8 System Operation describes how to operate the Console Section 9 Maintenance describes procedures for maintaining and cleaning the System Section 10 Emergency describes...

Page 6: ...distribution and use by or on the order of a physician The CentriMag Circulatory Support System is indicated for temporary circulatory support for up to 30 days for one or both sides of the heart to treat post cardiotomy patients who fail to wean from cardiopulmonary bypass providing a bridge to decision when it is unclear whether the patient s heart will recover or whether the patient will need a...

Page 7: ...Extracorporeal Blood Pumping System K020271 K051209 K053630 K081221 K083340 K090004 K102129 K131179 PL 0070 CentriMag Blood Pump IFU Federal U S A law restricts this device to sale distribution and use by or on the order of a physician The CentriMag Blood Pump is indicated for use with the 2nd Generation CentriMag Primary Console to pump blood through the extracorporeal bypass circuit for extracor...

Page 8: ...six hours not requiring complete CPB e g valvuloplasty circulatory support during mitral valve reoperation surgery of the vena cava or aorta liver transplants etc This device is not designed sold or intended for use except as indicated CentriMag Drainage Venous Cannula Kit K110983 K152190 PL 0220 CentriMag Drainage Venous Cannula Kit IFU Federal U S A law restricts this device to sale distribution...

Page 9: ...S Caution Statement s Indications for Use K152161 bypass circuit for extracorporeal circulatory support for periods up to six hours 2 2 Contraindications for Use The CentriMagTM Circulatory Support System is contraindicated for use as a cardiotomy suction device The System is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Hepar...

Page 10: ...ngs are located within the text of the subject matter to which the warning relates For this reason some of the warnings are included in more than one section 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 respe...

Page 11: ... the CentriMag and PediMag Pumps There are no safety or performance data that establish compatibility with any other manufacturer s device or components WARNING One additional CentriMag Console Motor and Flow Probe are required as backup components in the immediate vicinity of each patient whenever the CentriMag or PediMag Pump is used The backup Console must be connected to the backup Motor and t...

Page 12: ...patibility with any other manufacturer s device or components Use of any other component may result in a sudden Motor stop WARNING Before use of the CentriMag System always ensure that all components of the System are properly mounted with Abbott Medical elements Improper mounting can cause malfunction of the System CAUTION The System is intended for use in all establishments such as hospitals and...

Page 13: ...he System consist of a CentriMagTM or PediMagTM 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 Additional information regarding...

Page 14: ...CentriMagTM Circulatory Support System Operation Manual US Page 14 of 126 2019 Abbott Document No PL 0047 Rev 11 December 2019 Figure 2 PediMagTM Blood Pump ...

Page 15: ...CentriMagTM Circulatory Support System Operation Manual US Page 15 of 126 2019 Abbott Document No PL 0047 Rev 11 December 2019 Figure 3 CentriMag Motor ...

Page 16: ...CentriMagTM Circulatory Support System Operation Manual US Page 16 of 126 2019 Abbott Document No PL 0047 Rev 11 December 2019 Figure 4 2nd Generation CentriMag Primary Console ...

Page 17: ...CentriMagTM Circulatory Support System Operation Manual US Page 17 of 126 2019 Abbott Document No PL 0047 Rev 11 December 2019 Figure 5 Mag Monitor ...

Page 18: ...CentriMagTM Circulatory Support System Operation Manual US Page 18 of 126 2019 Abbott Document No PL 0047 Rev 11 December 2019 Figure 6 Flow Probe ...

Page 19: ...vicinity of the patient A backup System must also accompany a patient during transport Table 1 Main Backup System Elements System Component Main System Backup System 2nd Generation CentriMag Primary Console Motor Mag Monitor Flow Probe em tec Adult Flow Probe and em tec Pediatric Flow Probe 5 1 2 Optional CentriMagTM Circulatory Support System Components The following components are available as o...

Page 20: ...anual US Page 20 of 126 2019 Abbott Document No PL 0047 Rev 11 December 2019 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 ...

Page 21: ...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 The basic bearingless centrifugal principle is shown in Figure 7 An impeller is floating and rotating in the magnetic fields of a stator without mechanical contact A compact digital ...

Page 22: ...late the magnetic fields so that the impeller is always centered The electronics control precise regulation of the radial impeller position and the speed Axial position and tilting of the impeller are passively stabilized Figure 8 The non contacting impeller is levitated by magnetic fields through the walls of the Pump and floats in the center of the Pump Figure 8 Axial support a and stabilization...

Page 23: ...In the biventricular mode one Monitor is connected to two Consoles The display on the Monitor then displays data from both of the Consoles The data from the Console used to support the left side of the heart are displayed in red whereas the data from the Console used to support the right side of the heart are displayed in blue Should the Monitor be disconnected or fail the Console may be operated ...

Page 24: ...enus Data from up to two Consoles can be displayed simultaneously on one Monitor 5 1 4 2 Back Panel 5 1 4 2 1 Console Connection The Monitor back panel Figure 9 provides the required electrical inputs and outputs needed to connect the Monitor to one or two Consoles Each connector provides the input from and output to one Console 5 1 4 2 2 USB port Logger Data As shown in Figure 9 a USB port is pro...

Page 25: ...latory Support System Operation Manual US Page 25 of 126 2019 Abbott Document No PL 0047 Rev 11 December 2019 Figure 9 Monitor Back Panel USB Port Strictly for downloading data to a Memory Stick RS232 Port Ethernet Port ...

Page 26: ... printer 5 1 5 2nd 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 In addition each Console contains a rechargeable internal battery that ...

Page 27: ...flow of up to 2 0 LPM is displayed as a negative number such as 0 65 LPM Retrograde flow greater than 2 0 LPM is displayed as downward arrows vv vv LPM A disconnected or malfunctioning probe will display dashes If the probe detects forward flow of more than 10 LPM then it will display as LPM The Flow Probe used with the CentriMagTM Pump is an em tec Adult Flow Probe that is compatible with 3 8 ID ...

Page 28: ...ck panel Figure 12 provides the required mechanical inputs and outputs needed to operate a CentriMag or PediMag Pump Figure 12 Back Panel Motor Connector P1 P2 Pressure Connector AC Power Connector and Fuse Console Serial Number Label Monitor Connector ON OFF Button Flow Probe Connector Console Serial Number Product Reference Number Equipotential Bonding Post ...

Page 29: ...he potential for hemolysis and thrombus formation The Pumps are designed to move blood by centrifugal force created by the magnetically suspended rotating impeller Figure 13 a CentriMag Pump b PediMag Pump The blood flow is dependent upon the amount of blood entering the Pump the Pump speed RPM the extracorporeal circuit resistance and drainage and return blood pressures The relationship between p...

Page 30: ...M Motor Figure 15 holds the disposable CentriMag or PediMag Pump and drives the impeller inside the Pump Figure 15 CentriMagTM Motor 5 1 8 Backup Console The 2nd 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 ...

Page 31: ...tem 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 5 1 10 Application Software Compatible software versions for the System components are the following Console CPC1 02 Monitor MCM3 01 For information on displaying the Console Application Software see Section 7 8 For information on the Monitor M...

Page 32: ...0047 Rev 11 December 2019 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 Medical grade 3 8 inch PVC tubing ...

Page 33: ...tection against electric shock None Class 1 and internally powered Equipment Classification for protection against electric shock None Continuous Mode of Operation None Not for AP or APG Not suitable for use in the presence of a flammable anesthetic mixture None EtO for Pump Method of Sterilization None IPX0 enclosure Not splash proof Do not spray cleaning agents directly on Console or Monitor enc...

Page 34: ... Range 0 0 10 0 liters per minute LPM Flow Range Display 2 0 10 0 liters per minute LPM 1 Electrical Safety Earth leakage current 500 µA Touch current 100 µA Patient leakage current 10 µA 6 3 Environmental Conditions 6 3 1 Shipping Conditions The following are the acceptable environmental conditions during shipping Temperature 29o C to 60o C one week maximum Relative humidity 0 to 85 Atmospheric p...

Page 35: ...y interfere with the operation of other equipment in proximity Do not place equipment other than an additional Console near the main Console or Motor For information about potential interference from Electrosurgery Units ESU see Section 0 for more details WARNING The System is a Class A product and may cause radio interference in residential environments WARNING The System should not be used in Ma...

Page 36: ... found on the Console Control Panel Figure 17 It will display Pump speed flow and alarm limit data battery status and pressure information The Monitor can display the information for up to two Consoles simultaneously For more information about the Monitor see Section 7 24 The Monitor incorporates the same six soft keypads found on the Console control panel The first keypad at the top silences the ...

Page 37: ...CentriMagTM Circulatory Support System Operation Manual US Page 37 of 126 2019 Abbott Document No PL 0047 Rev 11 December 2019 Figure 18 Monitor ...

Page 38: ...dition and the audio paused symbol The audio paused symbol and visual indication of the alarm alert condition will only be removed provided a the condition was acknowledged by depressing the Alarm Acknowledge keypad and b the condition has resolved On the Console s Front Panel On the Monitor s Front Panel Menu Depressing this keypad will allow the user to select System settings to view or modify e...

Page 39: ...essed and covered to prevent inadvertent actuation Switching to OFF disables all functions and displays except for the battery charging function This power switch should not be used to stop the Pump To stop the Pump use either RPM Decrease or Emergency Pump Stop buttons On the Console s Back Panel Indicators Pump Speed Pump speed RPM Display The Top portion of the Console s display is the Pump Spe...

Page 40: ...rned off The estimated remaining battery time in minutes is indicated by a three digit numeric display The Battery charge status is displayed via a battery icon On the Console s Front Panel Battery time is also shown on the Monitor s screen Support side The letter L or R displayed on the right side of the digital display denotes Left Ventricular Support or Right Ventricular Support On the Console ...

Page 41: ...onnection for Console to AC power and fuse box Use only 5 x 20 mm T 3 15A H 250V fuses On the Console Back Panel Version 2 Flow Probe connector 15 Pin connection for the Flow Probe On the Console s Back Panel Equipotentiality Symbol IEC 60417 5021 The Equipotential Bonding Post EBP provides a low impedance electrical safety common connection point On the Console s Back Panel Pressure Probe Connect...

Page 42: ...nd Flow Probes FEATURE NAME DESCRIPTION LOCATION USB Port Connection for USB Memory Stick On Monitor s Back Panel RS232 Port2 Connection for RS232 On Monitor s Back Panel Ethernet Port3 Connection for Ethernet On Monitor s Back Panel 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 ...

Page 43: ... Console Back Panel Version 1 On the Console Back Panel Version 2 Abbott Medical Product Reference Number Identifies the Abbott Medical Reference reorder Number On the serial number label Serial Number Identifies the serial number of the Console On the serial number label Defibrillation proof Type CF Equipment Equipment type On the serial number label Read Manual Consult the CentriMag Circulatory ...

Page 44: ...rements of prescribed product safety standards Moreover the mark indicates that the production site conforms to a range of compliance measures and is subject to periodic follow up inspections to verify continued conformance On the serial number label Manufacturer Indicates the Manufacturer of the Console On the serial number label Waste Electrical and Electronic Equipment Waste Electrical and Elec...

Page 45: ...ating the device On the serial number label CE Mark with Notified Body ID CE Conformity European Mark with Notified Body designation On the serial number label Manufacturer Indicates the Manufacturer of the Console On the serial number label Waste Electrical and Electronic Equipment Waste Electrical and Electrical Equipment WEEE Mark On the serial number label Monitor USB Warning Label General War...

Page 46: ...es the audible alarm The alarm alert message will be continuously displayed on the top two lines of Row 2 of the Console s display as long as the alarm alert condition exists In the event of an alert or alarm condition see Table 13 or Table 16 for the full list of alarms and alerts visual message and audio indicators activate The Console continues Pump operation during an alert or MOTOR ALARM cond...

Page 47: ...ert alarm may reactivate under the following conditions and may require subsequent acknowledgment If the alert condition is unresolved and persists for more than 60 seconds after the alert alarm has been acknowledged the audio alert will reactivate If the alert alarm condition is resolved and then reoccurs E g transient FLOW BELOW MINIMUM condition resolves and then reoccurs The original text mess...

Page 48: ... and contact your local Abbott Medical representative WARNING A Pump stoppage will create a reverse flow shunt through the Pump as well as limit the body s ability to maintain adequate arterial pressure If the Pump is off or stopped clamping the return tubing from the Pump is necessary to prevent a low flow low pressure and reverse flow condition The tubing clamp must be removed before returning t...

Page 49: ...FAIL PRESSURE 1 BELOW MINIMUM PRESSURE 2 BELOW MINIMUM PRESSURE 1 ABOVE MAXIMUM PRESSURE 2 ABOVE MAXIMUM MOTOR OVER TEMP BATTERY CHARGER FAIL BATTERY MAINTENANCE REQUIRED LOW BATTERY ON BATTERY 6 9 Power Assembly The Power Assembly is located on the Console s back panel and contains the AC Power Connection Monitor Connection and LEMO Motor Connection 6 10 Requirements for Connecting Additional Equ...

Page 50: ...ctive Last state7 Pressure limits 30mmHg 200mmHg 30mmHg 200mmHg Language English Last state7 RPM Increment 100 Last state7 Flow Limit Sensitivity Normal Last state7 Recorder Speed 2 minutes 2 minutes 7 1 Unpacking 1 Remove the Console AC Power Cord and Flow Probe from the Console s shipping container 2 Remove the Motor from its shipping box 3 Remove the Monitor from its shipping box 4 Factory Defa...

Page 51: ...ure that the System cables Motor cable Flow Probe cable etc are organized properly in order to avoid accidents and reduce the likelihood of EMI EMI may interfere with the System and potentially may stop the Motor Prevent cable loops on the floor and avoid cables hanging over other equipment or furniture CAUTION Before each use verify that the cable connecting the Motor to the Console is not kinked...

Page 52: ... the CM Distance Holder and Console Standoff When mounting a single Console onto the System Cart use the CM Distance Holder to securely fix the Console in place Figure 19 Mounting of Single Console onto System Cart When mounting two stacked Consoles onto the System Cart use the CM Distance Holder in combination with Console Standoff to securely fix both Consoles in place Figure 20 Combination of D...

Page 53: ...rm can be mounted either on the edge of a horizontal or vertical solid surface or on a vertical pole For instructions on how to set up the Monitor Arm refer also to the manual provided by Ergotron Steps required to set up the Monitor Arm 1 Mount the Monitor Arm Clamp on the adapter plate Figure 22 illustrates the two possibilities for mounting the clamp on the adapter plate If the Monitor Arm is t...

Page 54: ...joint plate of the Monitor Arm to the adapter plate Make sure the orientation of the adapter plate is identical to the orientation of the root joint plate Figure 23 shows the assembly for vertical mounting Figure 23 Mounting of the Monitor Arm root joint plate on the adaptor plate 3 To mount the Monitor on the Monitor Arm use the four black screws that can be screwed by hand to allow for easy remo...

Page 55: ... Clamp on the object where the Monitor is to be fixed a solid surface or a solid pole The two clamping possibilities are shown in Figure 25 Figure 25 Horizontal or vertical mounting of the Monitor Arm 5 Assemble the Monitor Arm by following the instructions provided in the Ergotron manual LX Wall Mount LCD ARM which is included in the Monitor Arm packaging Figure 26 shows the complete Monitor asse...

Page 56: ...6 2019 Abbott Document No PL 0047 Rev 11 December 2019 Figure 26 Completely assembled Monitor Arm with Monitor WARNING 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 ...

Page 57: ...itor Arm only on vertical poles or on the edge of solid surfaces Figure 28 Do not mount the Monitor Arm on a horizontal pole 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 To m...

Page 58: ... onto the Motor Bracket use the Motor Screw attached to the Motor Bracket and use the threaded hole at the bottom of the Motor The Motor Screw can be screwed by hand to allow for easy removal of the Motor Make sure the screws are sufficiently tightened Figure 30 Completely assembled Monitor Bracket with Motor Clamp for mounting on a vertical pole Star Screw for mounting on a vertical pole Motor Sc...

Page 59: ...nt Mount the Motor Bracket only on vertical poles 7 5 Powering Up the Console To power up the main or backup console 1 Insert the Power Cord into the AC Power Connection located on the back of the Console Flip and press the connector latching mechanism over the base of the power connector in order to fully secure the power cord to the Console 2 Insert the cord into the AC wall outlet WARNING Inser...

Page 60: ...CentriMagTM Circulatory Support System Operation Manual US Page 60 of 126 2019 Abbott Document No PL 0047 Rev 11 December 2019 Figure 31 Correct Biventricular Assist Power Connection ...

Page 61: ...pply with a protective earth 3 Insert the LEMO connector on the Motor cable into the Motor connection on the rear of the Console Make sure the connector is fully inserted Check that the connector is fully seated by attempting to retract the connector and verifying that it remains within the receptacle 4 Connect the Flow Probe cable to the Console by tightening the two thumb screws to the mating th...

Page 62: ... switch located on the back panel of the Console 7 6 Self Test Initiation When the power is turned ON a sequence of self tests will immediately be performed All operating parameters will be verified If any test fails an appropriate message will be displayed and an alarm will occur WARNING Always verify two audio beepers sound during the self test If the audio beepers fail to operate the System wil...

Page 63: ...ssure measurement capability and calibrate the pressure transducers is accessed through the MENU keypad Figure 35 outlines the basic MENU scheme which is available after the support type has been selected When the System is driven by the Console and is connected to the Monitor the main user interface is the Monitor Figure 33 however most of the selections described below are accessible through the...

Page 64: ... be accessed by scrolling through the options MINIMUM FLOW ALERT SETTING MAXIMUM FLOW ALERT SETTING PRESSURE MENU PRESSURE CALIBRATION MINIMUM PRESSURE P1 ALERT SETTING MAXIMUM PRESSURE P1 ALERT SETTING MINIMUM PRESSURE P2 ALERT SETTING MAXIMIUM PRESSURE P2 ALERT SETTING STOPWATCH Monitor only EXTENDED MENU PRESSURE DISPLAY for one or two pressure probes SPEED STEP RESOLUTION FLOW RANGE SELECTION ...

Page 65: ...Structure 7 8 Console BIOS Note The System cannot be used while the Console BIOS is being accessed If the Monitor is attached it will only display the company logo while the BIOS is being accessed The Console BIOS contains engineering information about the Console For additional information on the Monitor Management see Section 7 25 To access the Console BIOS hold the MENU button on the Console du...

Page 66: ...M Exit Menu Increase Decrease Set RPM Set RPM Set RPM Set RPM Set RPM Set RPM Menu Menu Menu Menu Menu Menu Increase Decrease Enter Enter Start Stop Reset Stop Watch 2 Start Stop Reset Stop Watch 1 Monitor only Figure 36 Monitor MENU Structure Setting Maximum Flow Alert To change the MAXIMUM FLOW ALERT setting depress the MENU keypad until the MAX FLOW ALERT option is displayed Use the DECREASE or...

Page 67: ...ation of support the MINIMUM FLOW ALERT must be set to the minimal acceptable flow appropriate for the patient s size clinical condition and physiologic needs To change the MINIMUM FLOW ALERT value depress the MENU keypad until the MINIMUM FLOW ALERT option is displayed Use the DECREASE or INCREASE arrow keys to decrease or increase the alert setting The actual MINIMUM FLOW ALERT threshold is cont...

Page 68: ...ssure Menu If the pressure subsystem is active the pressure menu can be accessed by pressing ENTER while the PRESSURE MENU option is highlighted Activation and deactivation of the pressure subsystem is explained in Section 7 14 7 12 Setting the Max or Min Pressure Alert Settings for the P1 Transducer Pressure Menu Minimum P1 Alert Maximum P1 Alert Minimum P2 Alert Maximum P2 Alert Pressure Calibra...

Page 69: ...New Cal P1 Previous Cal P2 Figure 40 Monitor MENU Structure Setting the Max or Min Pressure Alert Settings for the P2 Transducer To change the MAXIMUM or MINIMUM PRESSURE ALERT settings for the P2 pressure transducer depress the MENU keypad to display PRESSURE MENU followed by ENTER Select either the MAX or MIN P2 ALERT options Use the DECREASE or INCREASE arrow keys to decrease or increase the al...

Page 70: ...RPM Menu L Select Enter Return Monitor only Extended Menu Set RPM Menu Confirm Execute Cancel Set RPM Menu Confirm Start Cancel Copy Data Management Support Type Language Data Logger Figure 41 Monitor MENU Structure Activating the Pressure Subsystem 2 To activate the pressure subsystem from the Monitor depress the MENU keypad to display EXTENDED MENU and ENTER Press MENU to display the PRESSURE DI...

Page 71: ...th a display resolution of 1 mmHg If one channel exceeds either limit the values displayed on the specific channel as well as the difference will be invalid which is indicated by either for values below 150 mmHg and for values above 900 mmHg If one channel is invalid then the difference will be displayed as dashes A Assuming the pressure monitoring system has been activated and calibrated a measur...

Page 72: ...RPM Menu Menu Menu Menu Menu Menu Increase Decrease Enter Enter Start Stop Reset Stop Watch 2 Start Stop Reset Stop Watch 1 Monitor only Figure 43 Monitor MENU Structure Stopwatches The stopwatches are provided for measuring times associated with the System They measure to the nearest second To start the timer depress the MENU button until the STOPWATCH option is displayed To start the stopwatch d...

Page 73: ... Support Type Language Data Logger Figure 44 Monitor MENU Structure Flow Range The System may be used to treat a variety of conditions to accommodate different ranges of flow Under different conditions the System may be operated in one of two flow ranges 0 10 LPM and 0 3 LPM Changing the flow range will adjust the range of the flow display bar as well as the default limit for the maximum flow alar...

Page 74: ... Extended Menu Set RPM Menu Confirm Execute Cancel Set RPM Menu Confirm Start Cancel Copy Data Management Support Type Language Data Logger Figure 45 Monitor MENU Structure Changing the flow recorder speed The System allows the user to alter the speed of the moving flow graph displayed on the bottom of the Monitor screen The available speeds are 2 minutes and 20 seconds The speed changes the amoun...

Page 75: ...gement Support Type Language Data Logger Figure 46 Monitor MENU Structure Speed Step Resolution The System may be used to treat patients with a wide range of body sizes and conditions The SPEED STEP RESOLUTION function is provided to allow the user to select smaller incremental changes in speed 50 RPM increments for small individuals and larger 100 RPM changes for the larger patients The default s...

Page 76: ...onfirm Execute Cancel Set RPM Menu Confirm Start Cancel Copy Data Management Support Type Language Data Logger Figure 47 Monitor MENU Structure Language Selection Language selection is a standard menu option The default language is English To change the language depress the MENU keypad and scroll down to the EXTENDED MENU option then use the MENU key to scroll through the menu options until the LA...

Page 77: ...ld the System alert the user that the flow has dropped below the MINIMUM FLOW ALERT setting the user is instructed to carefully reduce the speed RPM of the Pump until the hazardous condition is resolved Naturally care must be taken to provide sufficient flow for the patient while investigating the root cause of the event The Console may be operated with the FLOW LIMIT SENSITIVITY set in one of two...

Page 78: ...RPM Menu Next Normal 0 10 lpm Reduced 0 3 lpm Slow 2 min Fast 20 sec Set RPM Menu L Select Enter Return Monitor only Extended Menu Set RPM Menu Confirm Execute Cancel Set RPM Menu Confirm Start Cancel Copy Data Management Support Type Language Data Logger Figure 49 Monitor MENU Structure Setting Application Mode The Console can be used for a variety of conditions The display for each Console can b...

Page 79: ...ress the MENU keypad and scroll down to the EXTENDED MENU option then use the MENU key to scroll through the menu options until the DATA LOGGER option appears The Console can record approximately 16 hours of data When a Console is connected to the Monitor it uploads the data stored in the Console to the Monitor The Monitor can store several consecutive days of data The number of days is dependent ...

Page 80: ...ted every 15 min to give the total amount of time that the Console has been powered up Info This event is generated when the System is started stopped turned off and for System time changes Alarm This event is generated when a System alarm is activated See Table 13 for a list of alarms Alarm acknowledged This event is generated when the Alarm Acknowledge button is pressed and an alarm is still act...

Page 81: ...te the event took place For information on setting the System clock see Section 7 25 d Details on the event The System records details about the event This includes such detail as the alarm name and the exact parameter changes that have been made To navigate through the list of logged events use the UP ARROW and DOWN ARROW on the right of the Monitor to move up and down through the list of logged ...

Page 82: ...e copied to a USB Memory Stick A new session is started every time the Console is switched ON Connect a USB Memory Stick to the USB Port of the Monitor A connected Memory Stick is indicated with a USB Stick Icon in the status bar on the Monitor left of the date time indication WARNING Only USB compatible Memory Sticks may be used with the Monitor No other USB devices may be used e g printer with t...

Page 83: ...N as soon as it is connected to the Console The Monitor displays basic operational data and System status updates when the System is operated in either the biventricular or univentricular mode of operation The Monitor is designed to display information derived from one or two Consoles It is possible therefore to view data when the System is operated in the univentricular configuration LVAS or RVAS...

Page 84: ...retrieve information about the software version installed on the Monitor To access the MANAGEMENT Application depress the Menu keypad and scroll down to the MANAGEMENT entry Select START and CONFIRM using the UP and DOWN arrows The Monitor will reboot and display the words MANAGEMENT LOADING APPLICATION Note The rebooting sequence will only restart the Monitor and not the Console One other option ...

Page 85: ...e 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 This requires five complete counter clockwise rotations of the screw Failure to do so ...

Page 86: ...ile and cannot be sterilized Do not use the Console Monitor Motor and Flow Probe inside of the sterile field or in a location where they may come into contact with items that must remain sterile 8 1 1 Starting the Pump To start the Pump perform the following steps 1 Place the Pump into the Motor receptacle and secure in place per the Instructions for Use supplied with the Pump 2 Start the Pump by ...

Page 87: ...od circuit components 8 1 3 Manually Stopping the Pump Depressing and holding the STOP keypad on the Console s front panel for five seconds manually stops the Pump if the Pump is running While depressing the STOP keypad the message TO STOP PUMP HOLD DOWN STOP KEY will be displayed The FLOW BELOW MINIMUM alert message is then displayed if a Minimum Flow Alarm Level is set and the audible alarm soun...

Page 88: ...ing the tubing may cause increased risk of thromboembolic events WARNING Monitor patient s hemodynamics and the Console flow display to ensure the patient has adequate blood volume that the drainage cannula is properly positioned the Pump RPM is appropriate and desired flow is achieved Increase Pump RPM in small increments to minimize the risk of exceeding the available blood volume and causing dr...

Page 89: ...t condition occurs the audible advisory sounds along with a visual message indicating the cause s of the alarm alert condition on the alphanumeric display Depressing the ALARM ACKNOWLEDGE keypad temporarily mutes the audible alarm for most alarms and the audio paused symbol is displayed on the Console and the Monitor There are three high priority alarms which may not be muted Table 11 For all alar...

Page 90: ...ble 11 Console Alarms Alerts In Order Of Priority ID Alarm Alert Description Ability to Silence Audio Yes No Silence Interval8 S1 Alarm POWER ON TEST FAIL No S2 Alarm SYSTEM FAULT Run Time System Failure No M1 Alarm MOTOR STOPPED Yes 60 Sec M2 Alarm MOTOR DISCONNECTED Yes 60 Sec M3 Alarm PUMP NOT INSERTED Yes 60 Sec M4 Alarm MOTOR ALARM No M5 Alert SET PUMP SPEED NOT REACHED Yes 60 Sec B1 Alert BA...

Page 91: ...des a description of each advisory the System response and the anticipated response of the operator Also shown is the trigger for each alarm alert condition 8 3 Alarms In the event of an Alarm condition see Table 13 for alarm condition listing the Console stops the Pump The Console allows the user to acknowledge the Alarm which for all but two high priority alarms silences the audio alarm advisory...

Page 92: ...alarm message and contact your local Abbott Medical representative 8 3 1 Alarm Conditions Requiring Powering Off Before Restarting If during set up the Console produces an alarm condition listed in Table 12 turn the power switch to OFF check all cable connections and turn the power switch back to ON If the alarm reoccurs use another Console and Motor Do not use the suspect Console and Motor either...

Page 93: ...occurred or the condition has not been successfully resolved Note Should the alert condition be successfully resolved but the visual indication persists the user may clear the visual display by depressing the Alarm Acknowledge button Persistence of the visual display after depressing the Alarm Acknowledge button indicates the alert condition has not been resolved or has reoccurred If the alert con...

Page 94: ... screw If the alarm repeats switch to backup Console Motor and Flow Probe according the procedure described in Section 10 1 M4 Alarm MOTOR ALARM An audible alarm will sound and the System will continue to operate Press the alarm acknowledge button if the visual alarm message does not disappear clamp the return tubing stop the Pump and switch to the backup Console Motor and Flow Probe according the...

Page 95: ... Probe stop the Pump and switch to a backup Primary Console Follow the instructions described in Section 10 1 Resume support Record the alarm message and contact your Abbott Medical representative F3 Alert FLOW BELOW MINIMUM Low Flow Check for physiologic cause or circuit obstruction Check minimum flow set point Do not increase RPM without confirming adequate blood volume is available Common cause...

Page 96: ...up Motor stands free and is not covered e g blankets B3 Alert BATTERY CHARGER FAIL Press the alarm acknowledge button If the alert message repeats switch to backup System as described in Section 10 1 If this alarm is associated with BATTERY MODULE FAIL then carry out the procedure associated with that alarm B4 Alert BATTERY MAINTENANCE REQUIRED Do not use the Console Perform battery maintenance ac...

Page 97: ...urther warning AC power must be restored and the alarm acknowledged to prevent the Pump from stopping Alternatively the Motor and Pump may be switched to the backup Console Motor and Flow Probe to resume pumping operation CAUTION Always operate the System at the lowest acceptable clinical flows when operating on Console batteries to conserve remaining battery time Administer appropriate anticoagul...

Page 98: ...power regardless of whether the Console is ON or OFF the internal battery will discharge The rate of battery discharge will be greater if the Console is ON In order to prevent unintentional discharge of the battery always leave the unit plugged into AC Power The Console must be connected to AC Power to charge or maintain the battery charge but does not need to be powered ON ...

Page 99: ...s a reserve for emergency situations or in instances where exact battery support time cannot be estimated beforehand The Console should never be connected to ambulance derived AC mains power All 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 Moto...

Page 100: ...rt Vehicle Qualification 1 Planning adequate space is important Review the physical hardware specifications provided in Appendix II 2nd Generation CentriMag Primary Console Technical Specification 8 6 2 Console Considerations 1 Ensure that the Console s internal battery is fully charged prior to transport 2 A backup System should be fully assembled power cord backup Motor Flow Probe etc tested and...

Page 101: ... and Monitor has been successfully tested against applicable international standards for air and ground transport The System met all applicable requirements for the following standards IEC 60068 2 27 Basic Environmental Testing Procedures Shock IEC 60068 2 6 Environmental Testing Vibration RTCA DO 160G Environmental Conditions and Test Procedures for Airborne Equipment Test Levels o Section 20 5 R...

Page 102: ...9 WARNING The Console s internal battery must be fully charged prior to use The Console must be connected to AC power during storage to charge the battery If the 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 ...

Page 103: ...to the Release Tab Slot The Fuse Cartridge will partially eject 3 Gently remove the Fuse The fuses are secured in the end of the cartridge 4 Remove a blown fuse by pulling the fuse out from the cartridge and replace it only with an identical 5 x 20 mm T 3 15A L 250V fuse for Version 1 or T 3 15A H 250V fuse for Version 2 Consult Abbott Medical for recommended replacements 5 After blown fuses have ...

Page 104: ...the battery charge remaining indicator WARNING During routine maintenance verify that the fan is not blocked A faulty or blocked fan within the Console may cause overheating System malfunction or trigger an alarm Table 15 Console Maintenance Schedule Required Action After Each Use Every 6 Months Every 12 Months Every 2 Years Perform Battery Maintenance provided in Section 9 4 X Clean all external ...

Page 105: ...point during this procedure 2 First enter the Console BIOS by holding down the MENU key during System startup For more information on the Console BIOS see Section 7 8 3 Select START BATTERY MAINTAINANCE The System will begin to discharge the battery and will estimate the amount of time until the procedure is complete The procedure may take up to 24 hours to complete At some points the System may a...

Page 106: ...er Console as soon as possible 9 5 Motor Visual Inspection The cable that connects the CentriMag Motor to the CentriMag Console has been designed for and tested to withstand five years use however as any cable can be damaged during use or storage it should be visually inspected for damage prior to each use Complete the steps outlined below If any damage is found remove the Motor from service Figur...

Page 107: ... 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 These types of damage indicate wear and tear or previous rough handling of the cable which has the potential to result in internal wire damage Cable thickness and shape should be uniform throughout the length of ...

Page 108: ...rculatory Support System Operation Manual US Page 108 of 126 2019 Abbott Document No PL 0047 Rev 11 December 2019 Figure 60 Undamaged and Intact Motor Cable Figure 61 Damaged Motor Cable Figure 62 Damaged Motor Cable ...

Page 109: ...ardware by disconnecting the Pump from the main Motor and Console and switching to a backup Motor and backup Console Switching to a backup Console and Motor is performed in accordance with the steps shown in Figure 63 Switch all components Console Motor Flow Probe and cables simultaneously and then perform troubleshooting on the non functioning System when it is no longer being used for patient su...

Page 110: ...the Pump Be sure to reset options and alarms to match those selected before hardware exchange Figure 63 Emergency Switch to Backup System If the Pump has been OFF for more than five minutes without adequate anticoagulation or if there has been a Motor Overheating condition it will be necessary to replace the Pump and circuit including Cannulas NOTE To be available for emergency use the backup Cons...

Page 111: ...ten the retaining screw turn the Console power OFF and ON ensure no alerts are displayed and set the Console to begin pumping In instances other than Motor overheating when the Pump has been OFF for more than five minutes without adequate anticoagulation it will be necessary to replace the Pump and other circuit components 10 3 Defibrillation Cardioversion Defibrillation or cardioversion may be ne...

Page 112: ...follow the electrocautery manufacturer s instructions for prevention of interference with other electronic devices WARNING ESUs have the potential to interfere with other medical devices found in the operating and ICU room environment Ensure that the backup System is on and prepared for use in the event of a malfunction of the main Console during use of the ESU Survey the display of the main Conso...

Page 113: ...the user of this requirement In the European Union EU when a 2nd Generation CentriMag Console has reached end of life it must be treated as an electronic waste and disposed of in accordance with the European Directive 2002 96 EC Waste Electrical and Electronic Equipment WEEE and also in accordance with applicable local legislation Please comply with local waste collection system for electrical and...

Page 114: ... return tubing and 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 local Abbott Medical representative M2 Alarm MOTOR DISCONNECTED The Pump will stop An audible alarm will sound which can be muted for 60 seconds During setup of the System Press the alarm acknowledge button and check that th...

Page 115: ... to the backup Console Motor and Flow Probe according to the procedure described in Section 10 1 Resume support Record the alert message and contact Abbott Medical representative B1 Alert BATTERY MODULE FAIL The Console battery will not function An audible alarm will sound Switch to the backup Console Motor and Flow Probe according the procedure described in Section 10 1 Resume support Record the ...

Page 116: ...and recalibrate the transducer Consider changing the transducer and cable if the problem persists P3 Alert PRESSURE SYSTEM FAIL The pressure monitoring System will not function If pressure monitoring is needed then change to the backup Console Motor and Flow Probe Switch to the backup System according the procedure described in Section 10 1 Resume support Record the alarm message and contact your ...

Page 117: ...y out the procedure associated with that alarm B4 Alert BATTERY MAINTENANCE REQUIRED Do not use the Console Perform battery maintenance according to the instructions provided in Section 9 4 B5 Alert LOW BATTERY Plug the Console into AC power outlet to charge battery If no AC outlet is available switch to backup Console Motor and Flow Probe according to the procedure described in Section 10 1 Resum...

Page 118: ...w Range 0 0 10 0 liters per minute LPM Flow Range Display 2 0 10 0 liters per minute LPM Flow Resolution 10 mLPM Pressure Range Display 150 900 mmHg Alarm Alert Audio Volume 70 dB Language Options English Dutch French German Italian and Spanish Electrical Safety Earth leakage current 500 µA Touch current 100 µA Patient leakage current 10 µA Fuse 5 x 20 mm T 3 15A H 250V Shipping Condition Temperat...

Page 119: ...nglish Dutch French German Italian and Spanish Electrical Safety Earth leakage current 500 µA Touch current 100 µA Patient leakage current 10 µA Shipping Condition Temperature 29o C to 60o C 20o F to 140o F Relative humidity 0 to 85 Atmospheric pressure 210 hPa 1100 hPa 157 mmHg 825 mmHg Operational Storage Conditions Temperature 10o C to 30o C 50o F to 86o F Relative humidity 30 to 75 Atmospheric...

Page 120: ... 45mm 1 77 Thickness L3 25mm 0 98 Accuracy 0 0 to 1 0 LPM 0 1 LPM Offset Drift 1 0 to 10 0 LPM 7 of the value Offset Drift Flow Offset Drift max 0 03 LPM within 2 hours Ultrasound Frequency 15 kHz to 18 MHz different patterns possible resolution 8 bit Resolution 1 mLPM Retrograde Flow Detection Measured to 2 0 LPM Tubing Specification Tubing ID 9 5 mm 3 8 Wall Thickness 2 4 mm 3 32 Tubing OD 14 3 ...

Page 121: ... 29 Length L2 45mm 1 77 Thickness L3 25mm 0 98 Accuracy 0 0 to 1 0 LPM 0 1 LPM Offset Drift 1 0 to 8 0 LPM 7 of the value Offset Drift Maximum Slope Error max 0 03 LPM within 2 hours Ultrasound Frequency 15 kHz to 18 MHz different patterns possible resolution 8 bit Resolution 1 mLPM Retrograde Flow Detection Measured to 2 0 LPM Tubing Specification Tubing ID 6 4 mm 1 4 Wall Thickness 2 4 mm 3 32 T...

Page 122: ...pport System should assure that it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance RF emissions CISPR11 Group 1 The System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR11 Class A The System is suitable for use in all es...

Page 123: ...lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 ...

Page 124: ...mmunications equipment should be used no closer to any part of the System including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P d 1 2 P d 1 2 P 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the t...

Page 125: ...ment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the System is used exceeds the applicable RF compliance level above the System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the System d Over the fre...

Page 126: ...z to 80 MHz outside ISM bands d 1 2 P 150 kHz to 80 MHz inside ISM bands d 1 2 P 80MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 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 The ISM industrial scientific and medical bands between 150 kHz and ...

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