Thoratec CentriMag User manual

2nd Generation CentriMag System Operating Manual (US) Page 1 of 130
© 2019 Thoratec – Document No PL-0047, Rev 09 (May 2019)
2nd Generation CentriMag™ System
Operating Manual
For use with
CentriMag™ and PediMag™
Blood Pumping Systems
READ THE CENTRIMAG AND PEDIMAG PUMP INSTRUCTIONS FOR USE
(IFU) AND THE ENTIRE CONTENTS OF THIS MANUAL BEFORE USING THIS
DEVICE.
Thoratec Clinical & Technical Support Phone number(s)
Emergency HeartLine™:
Thoratec Corporation
Main Switchboard:
Tel: [phone]
Tel: [phone]
Fax: [phone]
Manufacturer:
Thoratec Switzerland GmbH
Technoparkstrasse 1
CH-8005 Zürich
Switzerland
www.thoratec.com
US Headquarters:
Thoratec Corporation
6035 Stoneridge Drive
Pleasanton, CA 94588
USA
www.thoratec.com
PL-0047, Rev 09
May 2019
DCO No 19-008

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© 2019 Thoratec – Document No PL-0047, Rev 09 (May 2019)
TABLE OF CONTENTS
1MANUAL OVERVIEW ...................................................................................... 5
2INDICATIONS & CONTRAINDICATIONS ....................................................... 6
2.1Indications for Use ............................................................................................... 6
2.2Contraindications for Use ..................................................................................... 6
3GENERAL CONVENTIONS AND LIMITED WARRANTY .............................. 7
3.1Warnings and Cautions ........................................................................................ 7
3.2Patents and Trademarks ...................................................................................... 7
3.3Conventions Used in This Manual ....................................................................... 7
4WARNINGS & PRECAUTIONS ....................................................................... 8
5DESCRIPTION ................................................................................................. 9
5.1General Overview ................................................................................................ 9
5.2Required User Supplied Items ........................................................................... 28
6SPECIFICATIONS AND GENERAL DESCRIPTION .................................... 29
6.1Classification ...................................................................................................... 29
6.2Specifications ..................................................................................................... 30
6.3Environmental Conditions .................................................................................. 30
6.4EMI Considerations ............................................................................................ 30
6.5Permanent Magnet Considerations ................................................................... 31
6.6Operator Controls .............................................................................................. 31
6.7Digital Display Information ................................................................................. 46
6.8Power Assembly ................................................................................................ 46
6.9Requirements for Connecting Additional Equipment ......................................... 46
7SETTING UP .................................................................................................. 47
7.1Unpacking .......................................................................................................... 48

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7.2Mag Monitor Mounting ....................................................................................... 49
7.3Motor Mounting .................................................................................................. 54
7.4Powering Up ...................................................................................................... 56
7.5Self-Test Initiation .............................................................................................. 59
7.6Configuring the 2nd Generation CentriMag Primary Console ............................. 60
7.72nd Generation CentriMag Primary Console BIOS ............................................. 63
7.8Setting the 2nd Generation CentriMag Primary Console Max Flow Alert ............ 64
7.9Setting the 2nd Generation CentriMag Primary Console Min Flow Alert ............. 65
7.10Entering the Pressure Menu .............................................................................. 66
7.11Setting the Max or Min Pressure Alert Settings for the P1 Transducer ............. 66
7.12Setting the Max or Min Pressure Alert Settings for the P2 Transducer ............. 67
7.13Activating the Pressure Monitoring System (Pressure Display) ......................... 67
7.14Stopwatches ...................................................................................................... 70
7.15Flow range ......................................................................................................... 71
7.16Changing the flow recorder speed ..................................................................... 72
7.17Setting the Console Speed Step Resolution ...................................................... 73
7.18Selecting Displayed Language .......................................................................... 74
7.19Setting the 2nd Generation CentriMag Primary Console flow limit sensitivity ..... 75
7.20Setting the Application Mode ............................................................................. 76
7.21The System Data Logger ................................................................................... 77
7.22Copy Logger Data to a USB Memory Stick ........................................................ 81
7.23Mag Monitor Description and Connections ........................................................ 82
7.24Accessing the Mag Monitor Management Application ....................................... 83
7.25Blood Pump Set-up ............................................................................................ 84
8OPERATING .................................................................................................. 85
8.1Operation of the Blood Pump ............................................................................. 85
8.22nd Generation CentriMag Primary Console Alarm/Alert Strategy ..................... 89
8.3Alarms ................................................................................................................ 92

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8.4Battery Operation ............................................................................................... 98
8.5Patient Transport ............................................................................................. 100
8.6Shut Down by Operator ................................................................................... 102
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 Blood Pump .................................................................... 111
10.3Defibrillation/ Cardioversion ............................................................................. 111
10.4Electrosurgical Units ........................................................................................ 112
11DISPOSAL OF EQUIPMENT ....................................................................... 113
12APPENDICES .............................................................................................. 114
12.1Appendix I – Primary Console Alarms and Alerts ............................................ 114
12.2Appendix II – Technical Specification .............................................................. 119
12.3Appendix III – Electromagnetic Emissions ....................................................... 124
12.4Appendix IV – Electromagnetic Immunity ........................................................ 125
12.5Appendix V – Similarities & Differences Between 1ST Generation & 2ND
Generation Primary Consoles .......................................................................... 130


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1 MANUAL OVERVIEW
Section 1: Manual Overview describes the organization of this Manual.
Section 2: Indications & Contraindications describes the intended use of the
CentriMag 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 2nd Generation CentriMag Primary Console.
Section 5: Device Description described the 2nd Generation CentriMag System
and each element within the System.
Section 6: Specifications and General Description describes the product
specifications and physical attributes of the 2nd Generation CentriMag
Primary Console.
Section 7: Setting up describes the procedure for unpacking the 2nd Generation
CentriMag Primary Console and configuring it for use.
Section 8: Operating describes how to operate the 2nd Generation CentriMag
Primary Console.
Section 9: Maintenance describes procedures for maintaining and cleaning the 2nd
Generation CentriMag Primary Console.
Section 10: Emergency describes procedures for managing the 2nd Generation
CentriMag Primary 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 2nd Generation CentriMag Primary Consoles
that have reached end of useful service life.
Section 12: Appendices
Appendix I: 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.
Appendix II: Technical Specification lists the product specifications and physical
attributes of the 2nd Generation CentriMag Primary Console.
Appendix III: Electromagnetic Emissions describes the electromagnetic
environmental conditions under which the 2nd Generation CentriMag
System may be operated.
Appendix IV Electromagnetic Immunity describes the electromagnetic
environmental conditions under which the 2nd Generation CentriMag
System may be operated.
Appendix V 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.

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2 INDICATIONS & CONTRAINDICATIONS
2.1 Indications for Use
As there are two different CentriMag System and one PediMag System Indications
For Use, please refer to the table below for exact Indications For Use:
Indications for Use Chart
Indications For Use Refer to Document No. Associated Caution Statement
PediMag System for
Cardiopulmonary Support
PL-0112, PediMag Blood
Pump IFU (CPB)
Federal (U.S.A.) law restricts
this device to sale, distribution
and use by or on the order of a
physician.
CentriMag System for
Cardiopulmonary Support
PL-0006-04, CentriMag Blood
Pump IFU (CPB)
Federal (U.S.A.) law restricts
this device to sale, distribution
and use by or on the order of a
physician.
CentriMag RVAS HDE
(H070004)
PL-0085, CentriMag Blood
Pump IFU (RVAS HDE)
Humanitarian Device: The
CentriMag RVAS is authorized
by Federal law to 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.
Distribution of this device is
restricted to use by or on the
order of a physician.
2.2 Contraindications for Use
The CentriMag and PediMag Systems are contraindicated for use as a cardiotomy suction
device. The Systems are also contraindicated for patients who are unable or unwilling to be
treated with appropriate anticoagulation such as Heparin or comparable alternative.

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3 GENERAL CONVENTIONS AND LIMITED WARRANTY
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 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.
3.2 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.
3.3 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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4 WARNINGS & PRECAUTIONS
WARNING
Read this Manual before using the 2nd Generation CentriMag Primary Console
(“Console”) with the CentriMag and PediMag 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 PediMag 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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5 DESCRIPTION
5.1 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
Enclosure Grey (RAL 7045) Silver (RAL 9006)
Design of Monitor Squared Edges Rounded Edges
Serial number of Console and
Monitor < L03000-0000 ≥ L03000-0000
Functional features Version 1 Version 2
Additional feature of Console - Monitor is available on
battery mode
Additional feature of Monitor
- Connectivity to RS
- Connectivity to Ethernet for
future use
The CentriMag System Version 1 and 2 are compatible with each other. Therefore the
individual component versions can be mixed. Be aware that the mixing may reduce the
functional features. For further information contact your local Thoratec representative.
The 2nd Generation CentriMag System is 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.

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Figure 1: CentriMag Blood Pump
Figure 2: CentriMag Motor

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Figure 3: 2nd Generation CentriMag Primary Console
d
Figure 4: Mag Monitor Version 1

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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 PediMag 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
PediMag Pump is 1.5 LPM compared to the maximum flow of the CentriMag Pump of 10.0
LPM.
Figure 7: PediMag Blood Pump

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5.1.1 CentriMag and PediMag 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
System Component Main System Backup
System
CentriMag or PediMag 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 and em-tec Pediatric Flow Probe for
PediMag Pump)
 
5.1.2 Optional CentriMag and PediMag System Components
The following components are available as optional accessories to the CentriMag and
PediMag 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 
5.1.3 Technology Overview
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 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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nd
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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
Impeller
stator
winding
impeller
inlet
outlet
Pump housing

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5.1.4 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 7.23).
The Mag Monitor is designed for use only with the 2nd Generation CentriMag Primary
Console 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 7.14), graphical displays of the pressure, as well as flow and alarm limits
(Sections 7.11 through 7.13).
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: The System with and without the Mag Monitor 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
System Component
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 
5.1.4.1 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.
5.1.4.2 Mag Monitor Back Panel
5.1.4.2.1 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.
5.1.4.2.2 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.
5.1.4.2.3 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.
5.1.4.2.4 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

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local Thoratec representative. Do not use this RS232 port without contacting your local
Thoratec representative.
Figure 10: Mag Monitor Back Panel Version 1
Figure 11: Mag Monitor Back Panel Version 2
RS232 Port
Ethernet Port
USB Port
(Strictly for
downloading
data to a
Memory-Stick)
USB Port
(Strictly for
downloading data to
a Memory-Stick)

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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).
5.1.5 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 1.5 LPM or a
maximum pressure head of 540 mmHg may be generated with the PediMag 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.
5.1.5.1 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

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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.
Figure 12: Front Panel – 2nd Generation CentriMag Primary Console
Figure 13: Digital Display – 2nd Generation CentriMag Primary Console
Flow Probes in two 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