CentriMag and PediVAS Blood Pump 2nd Generation System Operating Manual Rev 06 April 2016

TABLE OF CONTENTS 1

MANUAL OVERVIEW ... 5

2

GENERAL CONVENTIONS ... 6

3

4

5

2.1

Warnings and Cautions ...6

2.2

Patents and Trademarks ...6

2.3

Conventions Used in This Manual ...6

ABOUT THE 2ND GENERATION CENTRIMAG PRIMARY CONSOLE ... 7 3.1

Description ...8

3.2

Indications for Use (LVAS/RVAS/BiVAS/ECMO) ...27

3.3

Contraindications for Use ...27

3.4

Required User Supplied Items ...27

SPECIFICATIONS AND GENERAL DESCRIPTION ... 28 4.1

Classification ...28

4.2

Specifications ...29

4.3

Environmental Conditions ...29

4.4

EMI Considerations ...30

4.5

Permanent Magnet Considerations ...30

4.6

Operator Controls ...30

4.7

Digital Display Information ...42

4.8

Power Assembly...43

4.9

Requirements for Connecting Additional Equipment ...43

SETTING UP ... 44 5.1

Unpacking ...44

5.2

Mag Monitor Mounting ...45

5.3

Motor Mounting ...49

5.4

Powering Up ...51

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5.5

Self-Test Initiation...54

5.6

Configuring the 2nd Generation CentriMag Primary Console ...55

5.7

2nd Generation CentriMag Primary Console BIOS ...57

5.8

Setting the 2nd Generation CentriMag Primary Console Max Flow Alert... 58

5.9

Setting the 2nd Generation Centriag Primary Console Min Flow Alert ... 58

5.10

Entering the Pressure Menu ...59

5.11

Setting the Max or Min Pressure Alert Settings for the P1 Transducer ... 60

5.12

Setting the Max or Min Pressure Alert Settings for the P2 Transducer ... 60

5.13

Activating the Pressure Monitoring System (Pressure Display) ...61

5.14

Stopwatches ...63

5.15

Flow range ...64

5.16

Changing the flow recorder speed ...65

5.17

Setting the 2nd Generation CentriMag Primary Console Speed Step Resolution ...66

6

5.18

Selecting Displayed Language ...67

5.19

Setting the 2nd Generation CentriMag Primary Console flow limit sensitivity ... 68

5.20

Setting the Application Mode ...69

5.21

The System Data Logger...70

5.22

Copy Logger Data to a USB Memory Stick ...73

5.23

Mag Monitor Description and Connections ...74

5.24

Accessing the Mag Monitor Management Application...75

5.25

Blood Pump Set-up ...76

OPERATING ... 77 6.1

Operation of the Blood Pump ...77

6.2

2nd Generation CentriMag Primary Console Console Alarm/Alert Strategy ... 80

6.3

Alarms ...83

6.4

Battery Operation ...88

6.5

Patient Transport ...90

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6.6

7

Shut Down by Operator ...92

MAINTENANCE ... 93 7.1

Changing Fuses ...93

7.2

Maintenance Following Each Patient Use...93

7.3

Recommended Preventive Maintenance ...94

7.4

Battery Maintenance ...95

8

EMERGENCY / TROUBLESHOOTING ... 96 8.1

Switching to Backup Hardware ...96

8.2

Switching to another Blood Pump ...97

8.3

Defibrillation/ Cardioversion ...98

8.4

Electrosurgical Units ...98

9

DISPOSAL OF EQUIPMENT ... 99

10

APPENDICES... 100

10.1

Appendix I – 2nd Generation CentriMag Primary Console Alarms and Alerts .. 100

10.2

Appendix II – Technical Specification ...104

10.3

Appendix III – Electromagnetic Emissions ...110

10.4

Appendix IV – Electromagnetic Immunity ...111

10.5

Appendix V – Similarities & Differences Between 1ST Generation & 2ND Generation Primary Consoles...115

10.6

Appendix VI – Ordering Information; List of Article Numbers ... 116

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1 MANUAL OVERVIEW Section 1: Section 2:

Section 3: Section 4:

Section 5: Section 6: Section 7: Section 8:

Section 9:

Section 10: Appendix I:

Appendix II: Appendix III:

Appendix IV:

Appendix V:

Appendix VI:

Manual Overview describes the organization of this Manual. General Conventions describes warnings, cautions, and conventions of expression used in this Manual. Also, this section describes the Patents and Trademarks involved. About the 2nd Generation CentriMag Primary Console describes the general use of the Console. Specifications and General Description describes the product specifications and physical attributes of the 2nd Generation CentriMag Primary Console. Setting up describes the procedure for unpacking the 2nd Generation CentriMag Primary Console and configuring it for use. Operating describes how to operate the 2nd Generation CentriMag Primary Console. Maintenance describes procedures for maintaining and cleaning the 2nd Generation CentriMag Primary Console. Emergency describes procedures for managing the 2nd Generation CentriMag Primary Console during defibrillation and in the event of equipment malfunction. Disposal of Equipment describes the procedure for proper disposal of used Console batteries and 2nd Generation CentriMag Primary Consoles that have reached end of useful service life. Appendices Alarm/Alert Table lists the 2nd Generation CentriMag Primary Console’s audio/visual alarms and alerts and the expected System and operator response to each alarm or alert condition. Technical Specification lists the product specifications and physical attributes of the 2nd Generation CentriMag Primary Console. Electromagnetic Emissions describes the electromagnetic environmental conditions under which the 2nd Generation CentriMag System may be operated. Electromagnetic Immunity describes the electromagnetic environmental conditions under which the 2nd Generation CentriMag System may be operated. Similarities & Differences between the 1st Generation and the 2nd Generation CentriMag Primary Consoles compares key functions and attributes of the 1st Generation CentriMag Primary Console to the 2nd Generation CentriMag Primary Console. Ordering Information; List of Article Numbers

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2 GENERAL CONVENTIONS 2.1

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 2nd Generation CentriMag Primary Console.

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.

2.2

Patents and Trademarks

Patents: One or more U.S. patents, including U.S. Patent Number 6,100,618, cover this product and its use. Trademarks: THORATEC, the THORATEC LOGO, and THORATEC CORPORATION, are all registered trademarks of Thoratec Corporation. HeartLine™ is a trademark of Thoratec Corporation. CentriMag® and PediVAS® are registered trademarks of Thoratec Corporation and/or its subsidiaries.

2.3

Conventions Used in This Manual

Switches, keypads and connections on the 2nd Generation CentriMag Primary Console and Mag Monitor are indicated in NORMAL FACE TYPE IN UPPER CASE (e.g., POWER, STOP). The 2nd Generation CentriMag Primary Console and Mag 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., Blood Pump, Motor, Console and Mag Monitor). The headers for warnings are in red and the headers for cautions are in yellow.

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3 ABOUT THE 2ND GENERATION CENTRIMAG PRIMARY CONSOLE WARNING Read this Manual before using the 2nd Generation CentriMag Primary Console (“Console”) with the CentriMag and PediVAS Blood Pumps (“Blood Pump”). Thoratec requires users to undergo training prior to use of the Thoratec System.

WARNING The 2nd Generation CentriMag Primary Console is designed to be operated only with the CentriMag and PediVAS Blood Pumps. There are no safety or performance data that establish compatibility with any other manufacturer’s device or components.

WARNING One additional 2nd Generation CentriMag Primary Console, Motor and Flow Probe are required as backup System in the immediate vicinity of each patient whenever the CentriMag or PediVAS Blood 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.

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3.1

Description

3.1.1 General Overview There are two different CentriMag System versions, Version 1 and Version 2, which can be distinguished by physical characteristics and functional features (Table 1):

Table 1: Distinction between Version 1 & Version 2 Physical characteristics

Version 1

Version 2

Color of Console and Monitor Enclosures

Grey (RAL 7045)

Silver (RAL 9006)

Design of Monitor

Squared Edges

Rounded Edges

Serial number of Console and Monitor

< L03000-0000

≥ L03000-0000

Version 1

Version 2

Functional features Additional feature of Console

Monitor is available on battery mode Connectivity to RS

Additional feature of Monitor Connectivity to Ethernet for future use The CentriMag System Version 1 and 2 are compatible with each other. Therefore the individual components can be mixed. Be aware that the mixing may reduce the functional features. For further information contact your local Thoratec representative. The CentriMag and PediVAS Ventricular Assist Systems (VAS) are comprised of the following fundamental components: a) a single-use centrifugal Pump, b) a main Console, c) a main Motor, d) a Monitor Version 1 or e) Version 2, f) a Flow Probe, g) a backup Console, h) a backup Motor, i) a backup Flow Probe, j) Tubing (drainage and return), and k) Cannulae (drainage and return). The Extracorporeal Membrane Oxygenation (ECMO) configuration for the CentriMag and PediVAS Systems is virtually identical to the VAS configuration with the exception that an Oxygenator may be used as a component of the extracorporeal circuit. Neither peripheral Cannulae nor an oxygenator are provided by Thoratec for the ECMO configuration.

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Figure 1: CentriMag Blood Pump

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Figure 2: CentriMag Motor

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Figure 3: 2nd Generation CentriMag Primary Console

Figure 4: Mag Monitor Version 1

d

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Figure 5: Mag Monitor Version 2

Figure 6: Flow Probe

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The 2nd Generation CentriMag System may be used with either the CentriMag Pump as seen in Figure 1 or with the PediVAS Pump as shown in Figure 7 below. For each Pump, the 2nd Generation CentriMag Primary Console is operated in an identical manner and has the same Console display, alarms and alerts. However, the maximum flow range for the PediVAS Pump and circuit is 1.7 LPM compared to the maximum flow of the CentriMag Pump of 10.0 LPM.

Figure 7: PediVAS Blood Pump

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3.1.1.1 CentriMag and PediVAS System Components The components listed in Table 2 comprise the System. 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 2: Primary & Backup Elements of the System Main System

Backup System

CentriMag or PediVAS Blood Pump or CentriMag VAD Kit





2nd Generation CentriMag Primary Console





Motor





Mag Monitor



Flow Probe (em-tec Adult Flow Probe for CentriMag Blood Pump, em-tec Pediatric Flow Probe for PediVAS Pump and em-tec Thin-walled Pediatric Flow Probe for PediVAS Pump)



System Component



3.1.1.2 Optional CentriMag and PediVAS System Components The following components are available as optional accessories to the CentriMag and PediVAS Systems (Table 3):

Table 3: Optional Elements of the System System Component

Available for the CentriMag and PediVAS System

System Cart



Motor Bracket



Monitor Arm



Pressure Transducer Cables



Pressure Transducers



3.1.2 Technology Overview The CentriMag and PediVAS 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 8. An impeller is floating and rotating in the magnetic fields of a stator without mechanical contact. A compact digital signal processor system with a servo amplifier allows precise regulation of the impeller location and speed.

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pump housing

inlet impeller

outlet

Impeller

winding stator

Figure 8: Schematic depicting the basic principle of the bearingless centrifugal Pump and Motor External position sensors actively control the radial impeller position. Processor-controlled electronics regulate 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 9). The non-contacting impeller is levitated by magnetic fields through the walls of the Blood Pump, and floats in the center of the Pump.

Figure 9: Axial support (a) and stabilization against tilting (b) of the impeller by passive magnetic forces in the Blood Pump

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3.1.3 Mag Monitor The 2nd Generation CentriMag Primary Console is designed to be used with a Mag Monitor (Figure 4 and Figure 5). The Mag Monitor may be used with one or two 2nd Generation CentriMag Primary Consoles when a patient is supported in either a univentricular or biventricular support mode. The Mag Monitor permits the user to redundantly display data pertaining to System performance and status along with the Console display. When activated, the user is able to view System data directly on the Console display or the Mag Monitor. A second function of the Mag Monitor is to provide a redundant user interface to control Motor and Pump function. For detailed information regarding the Mag Monitor, refer to the appropriate section in this manual entitled “Mag Monitor Description and Connections” (Section 5.23). The Mag Monitor is designed for use only with the 2nd Generation CentriMag Primary Console. The Mag Monitor can be used when the System is stationary and powered on AC. In combination with the 2nd Generation CentriMag Primary Console Version 2 the Mag Monitor can be powered on battery as well. The runtime of the battery will shorten, if the Mag Monitor is used when the System is operated on battery. The Mag Monitor is not intended for use with the 1st Generation CentriMag Primary Console. In the biventricular mode, one Mag Monitor is connected to two 2nd Generation CentriMag Primary Consoles. The display on the Mag Monitor then displays data from both of the Consoles. The data from the Console used to support the left side of the heart is displayed in red, whereas the data from the Console used to support the right side of the heart is displayed in blue. Should the Mag Monitor be disconnected or fail, the 2nd Generation CentriMag Primary Console may be operated independently with the relevant operational data displayed on the Console display. When the Mag Monitor is active, control of Motor and Pump function may be accomplished using either the Mag Monitor or the Console. If a Mag Monitor is unavailable, the Pump and Motor can be controlled via the 2nd Generation CentriMag Primary Console. When operated in this manner, a number of features that can only be accessed via the Mag Monitor will not be available. These include; stopwatch function (Section 5.14), graphical displays of the pressure, as well as flow and alarm limits (Sections 5.11 through 5.13). In the absence of the Mag Monitor, the data log function is not accessible. In addition, data recording will be limited to the previous 16 hours of data. If a Mag Monitor is connected to the 2nd Generation CentriMag Primary Console it will be able to display the previous 16 hours of data collected by the System. Table 4 summarizes the differences between the System with and without the Mag Monitor.

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Table 4: The System with and without the Mag Monitor Mag Monitor Display & Functions

2nd Generation CentriMag Primary Console Display & Functions

Display of flow and RPM





Control of flow, RPM and auxiliary settings





Alarm limits for flow and pressure





Stopwatches



Multicolor display including flow and visual representation of flow, pressure and alarm limits



Use of the data log and display System



System Component

3.1.3.1 Mag Monitor Front Panel The role of the Mag Monitor (Figure 4 and Figure 5) is to display data from the 2nd Generation CentriMag Primary Console and to provide an alternative means of controlling the Console via the soft touch keys on the Mag Monitor. An LCD screen on the Mag Monitor is used to display operational data, System options and menus. Operator settable alarms and parameters are accessible via the System menus. Data from up to two 2nd Generation CentriMag Primary Consoles can be displayed simultaneously on one Mag Monitor.

3.1.3.2 Mag Monitor Back Panel 3.1.3.2.1 Console Connection The Mag Monitor back panel (Figure 10 and Figure 11) provides the required electrical inputs and outputs needed to connect the Mag Monitor to one or two 2nd Generation CentriMag Primary Consoles. Each connector provides the input from, and output to, one Console.

3.1.3.2.2 USB port – Logger Data As shown in Figure 10 and Figure 11, a USB port is provided on the rear panel of the Monitor between the two round connectors. The USB port provides access by a USB Memory Stick to download logger data stored in the Monitor.

3.1.3.2.3 Ethernet – Disabled (Version 2 only) The Mag Monitor Version 2 provides additional Ethernet port in the back panel as shown in Figure 11. The Ethernet port is intended for future use, and therefore it is disabled and does not have any function.

3.1.3.2.4 RS232 – Live Data (Version 2 only) The Mag Monitor Version 2 provides additional RS232 port in the back panel as shown in Figure 11. The RS232 port provides live data stream. For further information contact your local Thoratec representative. Do not use this RS232 port without contacting your local Thoratec representative.

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USB Port(Strictly for downloading data to a Memory-Stick)

Figure 10: Mag Monitor Back Panel Version 1

USB Port (Strictly for downloading data to a Memory-Stick) RS232 Port

Ethernet Port

Figure 11: Mag Monitor Back Panel Version 2

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CAUTION The Mag Monitor is intended for use only with the 2nd Generation CentriMag Primary Console. The Mag Monitor will not function with the 1ST Generation CentriMag Primary Console or any other Console.

WARNING The Mag Monitor can only be operated when it is connected to the 2nd Generation CentriMag Primary Console. The Console may be operational on AC or, in combination with the 2nd Generation CentriMag Primary Console Version 2, on battery. Operating the Mag Monitor while the Console runs on battery shortens the battery runtime. Refer to the individual RVAD or LVAD Console display for all operational data and audio/visual alarm messages.

WARNING Only USB-compatible Memory Sticks may be used to connect to the USB Port of the Mag Monitor. No other USB device may be used with the USB port (e.g. printer).

3.1.4 2nd Generation CentriMag Primary Console The 2nd Generation CentriMag Primary Console uses single phase AC power when used with the CentriMag Blood Pump. The 2nd Generation CentriMag System is capable of a flow rate of up to 10.0 LPM or maximum pressure head of 600 mmHg. Flows up to 1.7 LPM or a maximum pressure head of 540 mmHg may be generated with the PediVAS Blood Pump and circuit. In addition, each 2nd Generation CentriMag Primary Console contains a rechargeable internal battery that is capable of maintaining Console functionality in the event of a loss of AC power.

3.1.4.1 2nd Generation CentriMag Primary Console Front Panel The 2nd Generation CentriMag Primary Console (Figure 12 and Figure 13) is a microprocessor-based device. The microprocessors generate the primary Motor control signal, Mag Monitor System sensors, generate front display outputs and provide alarm functions. The microprocessors acquire the sensor data for use in generating operator displays and alarms. A graphical screen is used to display monitored data, System options and menus. Operator settable alarms and parameters are accessible via the System menus.

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Figure 12: Front Panel – 2nd Generation CentriMag Primary Console

Figure 13: Digital Display – 2nd Generation CentriMag Primary Console Flow Probes in three sizes are available for use with the 2nd Generation CentriMag Primary Console. Each Flow Probe is a reusable, non-patient contacting ultrasonic Flow Probe which is optimized to detect flows from 0-10.0 LPM or 0 – 3.0 LPM depending on probe size. The Flow Probes provided with the 1st Generation CentriMag Primary Console are not interchangeable with and will not work when connected to the 2nd Generation CentriMag Primary Console. The Flow Probes can detect retrograde flow. Retrograde 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 CentriMag Pump is an em-tec Adult Flow Probe that is compatible with 3/8” ID PVC tubing with a 3/32” wall thickness. The Flow Probe used with the PediVAS Pump is an em-tec Pediatric Flow Probe that is compatible with 1/4” ID Operating Manual 2nd Generation CentriMag System © 2016 Thoratec Switzerland GmbH– Document No PL-0280, Rev 06_English (April 2016)

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