CentriMag and PediMag 2nd Generation Operating Manual Rev 02 Dec 2011

TABLE OF CONTENTS 1

MANUAL OVERVIEW ...5

2

INDICATIONS & CONTRAINDICATIONS ...6

3

2.1

Indications for Use ... 6

2.2

Contraindications for Use... 6

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

3.4

Limited Warranty ... 7

4

WARNINGS & PRECAUTIONS ...9

5

DESCRIPTION ...10 5.2

6

7

Required User Supplied Items ... 26

SPECIFICATIONS AND GENERAL DESCRIPTION ...27 6.1

Classification ... 27

6.2

Specifications ... 27

6.3

Environmental Conditions ... 28

6.4

EMI Considerations... 28

6.5

Permanent Magnet Considerations ... 28

6.6

Operator Controls ... 29

6.7

Digital Display Information ... 39

6.8

Power Assembly ... 39

6.9

Requirements for Connecting Additional Equipment ... 39

SETTING UP ...41 7.1

Unpacking ... 41

7.2

Mag Monitor Mounting ... 42

7.3

Powering Up ... 45

7.4

Self-Test Initiation ... 47

7.5

Configuring the Console ... 48

7.6

Console BIOS ... 50

7.7

Setting the Console Max Flow Alert ... 51

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7.8

Setting the Console Min Flow Alert ... 51

7.9

Entering the Pressure Menu ... 52

7.10

Setting the Max or Min Pressure Alert Settings for the P1 Transducer ... 53

7.11

Setting the Max or Min Pressure Alert Settings for the P2 Transducer ... 53

7.12

Activating the Pressure Monitoring System (Pressure Display) ... 54

7.13

Stopwatches ... 56

7.14

Flow range ... 57

7.15

Changing the flow recorder speed ... 58

7.16

Setting the Console Speed Step Resolution ... 59

7.17

Selecting Displayed Language ... 60

7.18

Setting the Console flow limit sensitivity ... 61

7.19

Setting the Application Mode ... 62

7.20

The System Data Logger ... 63

7.21

Copy Logger Data to a USB Memory Stick... 66

7.22

Mag Monitor Description and Connections ... 67

7.23

Accessing the Mag Monitor Management Application ... 68

7.24

Blood Pump Set-up ... 69

8

OPERATING ...70 8.1

Operation of the Blood Pump... 70

8.2

Console Alarm/Alert Strategy... 73

8.3

Alarms ... 75

8.4

Battery Operation ... 81

8.5

Patient Transport ... 82

8.6

Shut Down by Operator ... 85

9

MAINTENANCE ...86 9.1

Changing Fuses ... 86

9.2

Maintenance Following Each Patient Use ... 87

9.3

Recommended Preventive Maintenance ... 87

9.4

Battery Maintenance ... 88

10

EMERGENCY / TROUBLESHOOTING ...90

10.1

Switching to Back-Up Hardware ... 90

10.2

Switching to another Blood Pump ... 92

10.3

Defibrillation/ Cardioversion ... 92

10.4

Electrosurgical Units ... 93

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11

DISPOSAL OF EQUIPMENT ...94

12

APPENDICES ...95

12.1

Appendix I – Primary Console Alarms and Alerts ... 95

12.2

Appendix II – Technical Specification ... 99

12.3

Appendix III – Electromagnetic Emissions ... 103

12.4

Appendix IV – Electromagnetic Immunity ... 104

12.5

Appendix V – Similarities & Differences Between Primary & CentriMag Back-Up Console ... 107

12.6

Appendix VI – Similarities & Differences Between 1ST Generation & 2ND Generation Primary Consoles ... 108

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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 and Limited Warranty describes warnings, cautions, and conventions of expression used in this Manual. Also, this section describes the Primary Console’s limited warranty.

Section 4:

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

Section 5:

Device Description described the system and each element within the system.

Section 6:

Specifications and General Description describes the product specifications and physical attributes of the Primary Console.

Section 7:

Setting up describes the procedure for unpacking the Primary Console and configuring it for use.

Section 8:

Operating describes how to operate the Primary Console.

Section 9:

Maintenance describes procedures for maintaining and cleaning the Primary Console.

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 Primary Consoles that have reached end of useful service life.

Section 12:

Appendices

Appendix I:

Alarm/Alert Table lists the 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 Primary Console.

Appendix III:

Similarities & Differences between the Primary & CentriMag BackUp Consoles compares key functions and attributes of the Primary Console to the CentriMag Back-Up Console.

Appendix IV:

Similarities & Differences between the Version I and Version II Consoles compares key functions and attributes of the Version I Console to the Version II Console.

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2 INDICATIONS & CONTRAINDICATIONS 2.1

Indications for Use

As there are four 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 VAS Pivotal Trial (G030052)

PL-0006-01, CentriMag Blood Pump IFU (Pivotal Trial)

Investigational Device. Limited by Federal (USA) law to investigational use.

CentriMag VAS for Pediatric Use Trial (G070087)

PL-0089, CentriMag Blood Pump IFU (Pediatric Trial)

Investigational Device. Limited by Federal (USA) law to investigational use.

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 This CentriMag and PediMag Systems are contraindicated for use as a cardiotomy suction device. It is 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 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: CentriMag® and PediMag® are registered trademarks of Thoratec Corporation.

3.3

Conventions Used in This Manual

Switches, keypads and connections on the Console and Mag Monitor are indicated in NORMAL FACE TYPE IN UPPER CASE (e.g., POWER, STOP). The 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.

3.4

Limited Warranty

A. Thoratec warrants the CentriMag Primary Console (the “Console”) to be free from defects in materials and workmanship for one (1) year following delivery of the Console to the original purchaser. Thoratec will repair or replace at its factory any part or parts of the Primary Console which it finds have become defective within the warranty period or Thoratec may elect to supply a replacement Console, or issue a credit to the purchaser of the Primary Console equal to the Purchase Price, in lieu of repairing any defective part or parts in such Console. 2nd Generation CentriMag Primary Console Operating Manual (US) © 2011 Thoratec – Document No. PL-0047, Rev. 02 (December 2011)

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B. To qualify for the repair, replacement, or credit set forth in Section A, the defective Primary Console must be returned to Thoratec thirty (30) days after discovery of the defect. Such repair, replacement, or credit, obligation does not apply to any Primary Console: 1) which has been repaired, or altered outside of Thoratec’ factory in any way which, in the judgment of Thoratec, affects its stability and reliability; or 2) which has been subjected to alterations, misuse, abuse, or accident. C. As used herein, the Purchase price shall mean the lesser of the original, or a functionally equivalent, or replacement Primary Console. D. This Limited Warranty is limited to its express terms. In particular: 1. Except as expressly provided by this Limited Warranty, THORATEC IS NOT RESPONSIBLE FOR ANY MATERIAL EXPENSES OR ANY INDIRECT, SPECIAL, EXEMPLARY, INCIDENTAL, OR CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT, FAILURE, OR MALFUCTION OF THE PRIMARY CONSOLE, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT, OR OTHERWISE. 2. This Limited Warranty is made only to the original purchaser of the Primary Console. AS TO OTHERS, THORATEC MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WHETHER ARISING FROM STATUE, COMMON LAW, CUSTOM, OR OTHERWISE. NO EXPRESS OR IMPLIED WARRANTY SHALL EXTEND BEYOND THE PERIOD SPECIFIED IN SECTION A ABOVE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE REMEDY AVAILABLE TO ANY PERSON. 3. NO PERSON HAS ANY AUTHORITY TO BIND THORATEC TO ANY REPRESENTATION, CONDITION, OR WARRANTY EXCEPT THIS LIMITED WARRANTY. (This Limited Warranty is not applicable to cables or other accessories used with this Primary Console).

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4 WARNINGS & PRECAUTIONS WARNING Read this Manual as well as the CentriMag Back-Up Console Manual before using the 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 Primary and CentriMag Back-Up Consoles are 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 CentriMag Back-Up Console and Motor are required in the immediate vicinity of each patient whenever the CentriMag or PediMag Blood Pump is used. The CentriMag Back-Up Console must be connected to the Back-Up Motor, 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 Primary Console or Primary Motor experience a malfunction.

WARNING The CentriMag Back-Up Console is not designed to replace the Primary Console but to serve as an emergency Back-Up unit for temporary support if the Primary Console has malfunctioned or is suspected to have malfunctioned. The patient must be returned to the Primary Console as soon as the malfunction has been resolved or a new Primary Console becomes available.

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5 DESCRIPTION 5.1.1 General Overview The 2nd Generation CentriMag System is comprised of the following fundamental components: a) a single-use centrifugal Pump, b) a Primary Motor, c) a Primary Console, d) a Monitor e) a Back-Up Motor, f) a CentriMag Back-Up Console, g) a Flow Probe.

a

b

c

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d

Figure 1: a) CentriMag blood pump b) Motor c) Primary Console and d) Monitor

The Primary Console is a fully functional Drive Console, equipped with flow monitoring, pressure sensing, and display capability. The patient is to be supported with the Primary Console at all times unless there is a malfunction necessitating exchanging the Primary Console for a CentriMag Back-Up Console (Figure 2).

Figure 2: CentriMag Back-Up Console The System may be used with either the CentriMag Pump as seen in Figure 1(a) or with the PediMag Pump as shown in Figure 3 below. For each pump, the 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. 2nd Generation CentriMag Primary Console Operating Manual (US) © 2011 Thoratec – Document No. PL-0047, Rev. 02 (December 2011)

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Figure 3: PediMag Blood Pump

5.1.1.1 CentriMag and PediMag System Components The components listed in Table 1 comprise the System. When a patient is supported on the Primary System, the Back-Up System must be available in the immediate vicinity of the patient. A Back-Up System must also accompany a patient during transport.

Table 1: Primary & Back-Up Elements of the System System Component

Primary System

Back-Up System

CentriMag or PediMag Blood pump or CentriMag VAD Kit

3

3

Primary Console

3

Motor

3

Mag Monitor

3

Flow Probe (em-tec Adult flow probe for CentriMag Blood Pump and em-tec Pediatric flow probe for PediMag Pump)

3

3

CentriMag Back-Up Console

3

CentriMag Back-Up Console Battery Module

3

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5.1.1.2 Optional CentriMag and PediMag System Components The following components are available as optional accessories to the CentriMag and PediMag Systems (Table 2):

Table 2: Optional Elements of the System Available for the Primary System

Available for the Back-Up System

System Cart

3

3

Motor Bracket

3

3

Monitor Arm

3

Pressure Transducer Cables

3

Pressure Transducers

3

System Component

5.1.2 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 4. 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.

pump housing

inlet impeller

outlet

Impeller

winding stator

Figure 4: 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 5). The non-contacting

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impeller is levitated by magnetic fields through the walls of the Blood Pump, and floats in the center of the Pump.

ω F

a)

F

Fz

Fz Fr

Fr

ω F

b )

Fr

Fz Fr

Mk

Fz F

Figure 5: Axial support (a) and stabilization against tilting (b) of the impeller by passive magnetic forces in the Blood Pump

5.1.3 Mag Monitor The Primary Console is designed to be used with a Mag Monitor (Figure 1(d)). The Mag Monitor may be used with one or two 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 Primary Console display. When activated, the user is able to view system data directly on the Primary Console 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 7.22). The Mag Monitor is designed for use only with the 2nd Generation CentriMag Primary Console when the System is stationary and powered on AC. The Mag Monitor is not intended for use when the Primary Console is operating on battery power. The rationale for not having the Monitor used when on battery power is to extend the life of the batteries. The Mag Monitor is also not intended for use with the 1st Generation CentriMag Primary Console or the CentriMag Back-Up Console. In the biventricular mode, one Mag Monitor is connected to two Primary Consoles. The display on the Mag Monitor then displays data from both of the Consoles. The data from the Primary Console used to support the left side of the heart is displayed in red, whereas the data from the Primary Console used to support the right side of the heart is displayed in blue. Should the Mag Monitor be disconnected or fail, the Primary Console may be operated independently with the relevant operational data displayed on the Primary Console display. When the Mag Monitor is active, control of Motor and Pump function may be accomplished using either the Mag Monitor or the Primary Console.

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If a Mag Monitor is unavailable, the Pump and Motor can be controlled via the 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 7.13), graphical displays of the pressure, as well as flow and alarm limits (Sections 7.10 through 7.12). 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 Primary Console it will be able to display the previous 16 hours of data collected by the system. Table 3 summarizes the differences between the system with and without the Mag Monitor.

Table 3: The System with and without the Mag Monitor Mag Monitor Display & Functions

Primary Console Display & Functions

Display of flow and RPM

3

3

Control of flow, RPM and auxiliary settings

3

3

Alarm limits for flow and pressure

3

3

Stopwatches

3

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

3

Use of the data log and display system

3

System Component

5.1.3.1 Mag Monitor Front Panel The role of the Mag Monitor (Figure 1d) is to display data from the Primary Console and to provide an alternative means of controlling the Primary 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 Primary Consoles can be displayed simultaneously on one Mag Monitor.

5.1.3.2 Mag Monitor Back Panel The Mag Monitor back panel (Figure 6) provides the required electrical inputs and outputs needed to connect the Mag Monitor to one or two Primary Consoles. Each connector provides the input from, and output to, one Primary Console. As shown in Figure 6, 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.

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

Figure 6: Mag Monitor Back Panel

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 Primary Console, the CentriMag Back-Up Console, or any other console.

WARNING The Mag Monitor can only be operated when it is connected to the Primary Console and the Primary Console is operational on AC power. The Mag Monitor is not intended for use when the Primary Console is operating on battery power. Refer to the individual RVAD or LVAD Primary Console display for all operational data and audio/visual alarm messages when operational on Battery Power.

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).

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5.1.4 Primary Console The Primary Console uses single phase AC power, when used with the CentriMag Blood Pump. The 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 Primary Console contains a rechargeable internal battery that is capable of maintaining Console functionality in the event of a loss of AC power.

5.1.4.1 Primary Console Front Panel The Primary Console (Figure 7 and Figure 8) is a microprocessor-based device. The microprocessors generate the primary Motor control signal, 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.

Figure 7: Front Panel – Primary Console

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Figure 8: Digital Display – Primary Console

Flow Probes in two sizes are available for use with the 2nd Generation 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 Primary Console are not interchangeable with and will not work when connected to the 2nd Generation 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 PediMag Pump is an em-tec Pediatric Flow Probe that is compatible with 1/4” ID PVC tubing with 3/32” wall thickness. Both probes incorporate a molded clip-on design for easy care and handling.

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5.1.4.2 Primary Console Back Panel The Primary Console back panel (Figure 8) provides the required mechanical inputs and outputs needed to operate a CentriMag or PediMag Blood Pump. Motor Connector

Flow Probe Connector

ON / OFF Button

P1 & P2 Pressure Connector

CentriMag Console Serial Number Label

Thoratec Product Reference Number

Console Serial Number

Monitor Connector

AC Power Connector and Fuse

Equipotential Bonding Post

Figure 9: Back Panel – Primary Console

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5.1.5 CentriMag and PediMag Blood Pumps The System uses a sterile, single-use, disposable, polycarbonate, CentriMag or PediMag Centrifugal Blood Pump (Figure 10a and b). The use of magnetic levitation eliminates the need for bearings and seals in the blood pathway. Elimination of these components is designed to minimize blood trauma and the potential for hemolysis and thrombus formation. The Blood Pumps are designed to move blood by centrifugal force created by the magnetically suspended rotating impeller.

Figure 10: a) CentriMag Blood Pump

b) PediMag Blood Pump

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