CentriMag Circulatory Support Systems Operation Manual Rev 11 Dec 2019

TABLE OF CONTENTS 1

MANUAL OVERVIEW ...5

2

INDICATIONS AND CONTRAINDICATIONS ...6

3

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

4

WARNINGS AND PRECAUTIONS ...11

5

DESCRIPTION ...13

6

7

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

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8

7.1

Unpacking ... 50

7.2

Console Mounting ... 52

7.3

Monitor Mounting... 53

7.4

Motor Mounting ... 57

7.5

Powering Up the Console ... 59

7.6

Self-Test Initiation... 62

7.7

Configuring the Console ... 63

7.8

Console BIOS ... 65

7.9

Setting the Console Max Flow Alert ... 66

7.10

Setting the Console Min Flow Alert ... 67

7.11

Entering the Pressure Menu ... 68

7.12

Setting the Max or Min Pressure 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 sensitivity ... 77

7.21

Setting the Application Mode ... 78

7.22

The System Data Logger... 79

7.23

Copy Logger Data to a USB Memory Stick ... 82

7.24

Monitor Connection ... 83

7.25

Accessing the Monitor Management Application ... 84

7.26

Pump Set-up ... 85

SYSTEM OPERATION ...86 8.1

Operation of the Pump ... 86

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8.2

Console Alarm/Alert Strategy ... 89

8.3

Alarms ...91

8.4

Battery Operation ... 96

8.5

Operation of the CentriMagTM Circulatory Support System On Internal Console Battery Power ... 99

8.6

Patient Transport ... 100

8.7

Shut Down by Operator ... 101

9

MAINTENANCE ...103 9.1

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

Appendix I – Console Alarms and Alerts... 114

12.2

Appendix II – Technical Specification ... 118

12.3

Appendix III – Electromagnetic Emissions ... 122

12.4

Appendix IV – Electromagnetic Immunity ... 123

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1 MANUAL OVERVIEW This manual provides technical information and use instructions for the CentriMagTM 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. Section 1:

Manual Overview describes the organization of this Manual.

Section 2:

Indications & Contraindications describes the intended use of the System.

Section 3:

General Conventions describes warnings, cautions, and conventions of expression used in this Manual. Also, this section describes the Patents and Trademarks involved.

Section 4:

Warnings & Precautions describes warnings and cautions to be considered when using the System.

Section 5:

Device Description describes the System and each element within the System.

Section 6:

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 procedures for managing the Console during defibrillation and in the event of equipment malfunction.

Section 11:

Disposal of Equipment describes the procedure for proper disposal of used Console batteries and Consoles that have reached end of useful service life.

Section 12:

Appendices

Appendix I:

Alarm/Alert Table lists the Console’s audio/visual alarms and alerts and the expected System and operator response to each alarm or alert condition.

Appendix II:

Technical Specification lists the product specifications and physical attributes of the Console.

Appendix III:

Electromagnetic Emissions describes the electromagnetic environmental conditions under which the System may be operated.

Appendix IV

Electromagnetic Immunity describes the electromagnetic environmental conditions under which the System may be operated.

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2 INDICATIONS AND CONTRAINDICATIONS 2.1

Indications for Use

The CentriMagTM Circulatory Support System and its components may be used only for their intended purpose. The indications for use for the individual system components vary within the United States. Refer to the table below for specific Indications For Use by device product name. Indications for Use Chart Product Name and Market Application Number

Refer to Label Part No.

Required US Caution Statement(s)

Indications for Use

CentriMag Circulatory Support System

PL-0047, CentriMag Circulatory Support System Operation Manual

Federal (U.S.A.) law restricts this device to sale, 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 alternative, longer-term therapy [PMA Approved Device].

PL-0085, CentriMag RVAS (Pump) IFU

The CentriMag Circulatory Support System is indicated for use as a right ventricular assist device [Humanitarian Device]. The System, when used as a right ventricular assist device is also authorized by Federal law to

The CentriMag Circulatory Support System is indicated for use as a right ventricular assist device [Humanitarian Device]. The System, when used as a right ventricular assist device is also authorized by Federal law to

PMA P170038

CentriMag Right Ventricular Assist System (RVAS) HDE H070004

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Indications for Use Chart Product Name and Market Application Number

CentriMag Extracorporeal Blood Pumping System

Refer to Label Part No.

Required US Caution Statement(s)

Indications for Use

provide temporary circulatory support for up to 30 days for patients in cardiogenic shock due to acute right ventricular failure. The effectiveness of this device for this use has not been demonstrated.

provide temporary circulatory support for up to 30 days for patients in cardiogenic shock due to acute right ventricular failure. The effectiveness of this device for this use has not been demonstrated.

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 extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (CPB) for up to six hours. It is also indicated for use in extracorporeal support systems (for periods up to 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.

PL-0112, PediMag

Federal (U.S.A.) law

The PediMag Blood

K020271 K051209 K053630 K081221 K083340 K090004 K102129 K131179

PediMag Blood

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Indications for Use Chart Product Name and Market Application Number

Refer to Label Part No.

Required US Caution Statement(s)

Indications for Use

Pump

Blood Pump IFU

restricts this device to sale, distribution and use by or on the order of a physician.

Pump is indicated for use only with the 2nd Generation CentriMag Primary Console to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (CPB) for up to six hours. It is also indicated for use in extracorporeal support systems (for periods up to 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.

PL-0220, CentriMag Drainage (Venous) Cannula Kit IFU

Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a physician.

The CentriMag Drainage (Venous) Cannula is indicated for use with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.

PL-0221, CentriMag Return (Arterial) Cannula Kit IFU

Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a physician.

The CentriMag Return (Arterial) Cannula is indicated for use as an arterial return cannula with an extracorporeal

K090051

CentriMag Drainage (Venous) Cannula Kit K110983 K152190

CentriMag Return (Arterial) Cannula Kit K110980

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Indications for Use Chart Product Name and Market Application Number

Refer to Label Part No.

Required US Caution Statement(s)

K152161

2.2

Indications for Use

bypass circuit for extracorporeal circulatory support for periods up to six hours.

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 Heparin or a comparable alternative.

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3 GENERAL CONVENTIONS 3.1

Warnings and Cautions

Read and observe all WARNINGS and CAUTIONS listed in this Manual and observe relevant instructions and safety precautions throughout operation of the System.

WARNING (Definition) Warnings are used if there is a potential for a serious hazard with misuse of the device, when special attention is required for safety of the patient, or when special care should be exercised to prevent improper operation of the device that may cause damage.

CAUTION (Definition) Cautions are used to alert the user to exercise special care for the safe and effective use of the device. Warnings 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 respective owner. Pat. http://www.abbott.com/patents © 2019 Abbott. All Rights Reserved.

3.3

Conventions Used in This Manual

Switches, keypads and connections on the Console and Monitor are indicated in NORMAL FACE TYPE IN UPPER CASE (e.g., POWER, STOP). The Console and Monitor displays are indicated in BOLD FACE TYPE IN UPPER CASE (e.g., SET SPEED, INCREASE, DECREASE, ON BATTERY). The first letter in the name of each System component is capitalized (e.g., Pump, Motor, Console and Monitor). The headers for warnings are in red and the headers for cautions are in yellow.

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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. The professional staff at Abbott Medical regularly provide laboratory training and on-site, in-service programs. For information, please contact your local Abbott Medical Clinical Field representative.

WARNING The System is designed to be operated only with 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 to the backup Flow Probe, have a battery charge sufficient for at least one hour of operation, be connected to AC power (except during transport) and be immediately available should the main Console, Motor or Flow Probe experience a malfunction.

WARNING The safety and effectiveness of use of the System in an ECMO circuit (i.e. cardiopulmonary support > 6 hours) has not been demonstrated.

WARNING The safety and effectiveness of use of the System for use > 30 days has not been demonstrated.

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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.

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 medical centers, but not in domestic/residential buildings and environments.

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5 DESCRIPTION 5.1

General Overview

The CentriMagTM Circulatory Support System is designed to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support. The core components of the 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 the individual components of the system, including optional accessories, can be found in the sections below.

Figure 1: CentriMagTM Blood Pump

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Figure 2: PediMagTM Blood Pump

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Figure 3: CentriMag Motor

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Figure 4: 2nd Generation CentriMag Primary Console

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Figure 5: Mag Monitor

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Figure 6: Flow Probe

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CentriMagTM Circulatory Support System Components

5.1.1

The components listed in Table 1 comprise the main and backup Systems. When a patient is supported on the main System, the backup System must be available in the immediate vicinity of the patient. A backup System must also accompany a patient during transport.

Table 1: Main & Backup System Elements 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)



System Component

5.1.2



Optional CentriMagTM 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

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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

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