CentriMag Primary Console Operating Manual Rev 00 Sept 2006

TABLE OF CONTENTS

1

MANUAL OVERVIEW ... 4

2

GENERAL CONVENTIONS ... 5 2.1

Warnings and Cautions ... 5

2.2

Patents and Trademarks ... 5

2.3

Conventions Used in This Manual... 5

3

ABOUT THE PRIMARY CONSOLE... 6 3.1

Description ... 6

3.2

Application Software Version ... 14

3.3

Indications for Use ... 14

3.4

Contraindications for Use ... 14

3.5

Required User Supplied Items ... 14

4

SPECIFICATIONS AND GENERAL DESCRIPTION ... 15 4.1

Classification ... 15

4.2

Specifications ... 15

4.3

Environmental Conditions ... 16

4.4

EMI Considerations... 16

4.5

Permanent Magnet Considerations... 16

4.6

Console Control Panel ... 17

4.7

Digital Display Information... 23

4.8

Power Assembly ... 23

5

SETTING UP ... 24 5.1

Unpacking ... 24

5.2

Powering Up... 25

5.3

Self-Test Initiation ... 25

5.4

Configuring the Console... 26

5.5

Setting the Console MINIMUM FLOW ALERT ... 28

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5.6

Setting the Console MAXIMUM FLOW ALERT... 28

5.7

Setting the Console FLOW LIMIT SENSITIVITY... 28

5.8

Activating the Pressure Monitoring System (PRESSURE DISPLAY)... 29

5.9

Setting the Console SPEED STEP RESOLUTION ... 30

5.10

Selecting Displayed LANGUAGE... 30

5.11

Blood Pump Set-up ... 30

6

OPERATING ... 32 6.1

Operation of the Blood Pump ... 32

6.2

Console Alarm/Alert Strategy ... 34

6.3

Alarms ... 37

6.4

Alerts... 38

6.5

Battery Operation ... 38

6.6

Patient Transport... 39

7

8

9

MAINTENANCE ... 44 7.1

Changing Fuses ... 44

7.2

Maintenance Following Each Patient Use... 45

7.3

Recommended Preventive Maintenance ... 46

EMERGENCY... 47 8.1

Switching to Back-Up Hardware... 47

8.2

Switching to another Blood Pump ... 49

8.3

Defibrillation/ Cardioversion ... 49 DISPOSAL OF EQUIPMENT ... 51

APPENDIX I – CENTRIMAG PRIMARY CONSOLE ALARMS & ALERTS... 52 APPENDIX II – TECHNICAL SPECIFICATION ... 53 APPENDIX III – SIMILARITIES & DIFFERENCES BETWEEN PRIMARY & BACKUP CONSOLE ... 54

CentriMag Primary Console Operating Manual © 2006 Thoratec Corporation – Document No. PL-0074, Rev. 00 (September 2006)

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1 MANUAL OVERVIEW Section 1:

Manual Overview describes the organization of this Manual.

Section 2:

General Conventions describes warnings, conventions of expression used in this Manual.

Section 3:

About the CentriMag Primary Console describes the general use of the Primary Console.

Section 4:

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

Section 5:

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

Section 6:

Operating describes how to operate the Primary Console.

Section 7:

Maintenance describes procedures for maintaining and cleaning the Primary Console.

Section 8:

Emergency describes procedures for defibrillation and equipment malfunction.

Section 9:

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

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 for the CentriMag Primary Console.

Appendix III:

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

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cautions,

and

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2

GENERAL CONVENTIONS

2.1

Warnings and Cautions

Read and observe all WARNINGS listed in this Manual and observe relevant instructions and safety precautions throughout operation of the CentriMag Primary Console.

WARNING Warnings are used to prevent misuse of the device, ensure patient safety, or when special care should be exercised to prevent improper operation of the device which may potentially harm the patient or the device.

CAUTION 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® is a registered trademark and HeartLine™ is a trademark of Thoratec Corporation. Levitronix® and CentriMag® are registered trademarks of Levitronix LLC. 2.3

Conventions Used in This Manual

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

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3

ABOUT THE PRIMARY CONSOLE WARNING Read this Manual before using the CentriMag Console with the CentriMag Blood Pump. Thoratec requires users to undergo training prior to use of the Thoratec CentriMag System.

WARNING The CentriMag Primary and Back-Up Consoles are designed to be operated only with the CentriMag Blood Pump. There are no safety or performance data that establish compatibility with any other manufacturer’s device or components.

WARNING A CentriMag Back-Up Console and Motor are required in the immediate vicinity of the patient whenever the CentriMag System is used. The BackUp Console must be plugged in and available should the primary Console 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. 3.1

Description

3.1.1

General Overview

As shown in Figure 1, the CentriMag System is comprised of five fundamental components: a) a single-use centrifugal Pump, b) a Motor, c) a Primary Console, d) a Back-Up Console, and e) a flow probe.

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Figure 1: a) CentriMag Blood Pump, b) Motor and c) Primary Console

Figure 1d: CentriMag Back-Up Console The CentriMag Primary Console is a fully functional Drive Console, equipped with flow and pressure sensing and display capability. The patient is to be supported with the Primary Console at all times unless there is a malfunction or failure necessitating exchanging the CentriMag Primary Console for a CentriMag Back-Up Console. 3.1.2

Technology Overview

The Thoratec CentriMag Blood Pump is an electronically driven, centrifugal Pump based on bearingless electric motor technology. The bearingless centrifugal Pump allows pumping without mechanical bearings and seals. The basic principle is shown in Figure 2. A rotor 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 rotor speed.

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inlet

pump housing

impeller

outlet

rotor

winding stator

Figure 2: Schematic with the basic principle of the bearingless centrifugal Pump

External position sensors actively control the radial rotor position. Processorcontrolled electronics regulate the magnetic fields so that the rotor is always centered. The electronics also allow precise regulation of the radial rotor position and the speed. Axial position and tilting of the rotor are passively stabilized (Figure 3). Only the noncontact rotor floats in the Blood Pump and is levitated by magnetic fields through its walls. ω F

a)

F

Fz

Fz Fr

Fr

ω F

b )

Fr

Fz Fr

Mk

Fz F

Figure 3: Axial support (a) and stabilization against tilting (b) of the rotor by passive magnetic forces in the CentriMag Blood Pump

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3.1.3 System 3.1.3.1

CentriMag System Components

The components listed in Table 1 comprise the CentriMag System. When a patient is supported on the Primary System, the Back-Up System must be available in the immediate vicinity of the patient. Table 1: Primary & Back-Up Elements of the CentriMag System System Component

Primary System

Back-Up System

CentriMag Blood Pump CentriMag Primary Console CentriMag Motor CentriMag Flow Probe CentriMag Back-Up Console CentriMag Back-Up Console Battery Module

3 3 3 3

3

3.1.3.2

3 3 3

Optional CentriMag System Components

The following components are available as accessories to the CentriMag System (Table 2): Table 2: Optional Elements of the CentriMag System System Component CentriMag Console Cart CentriMag Portable Stand CentriMag Motor Bracket CentriMag Pressure Transducer Cables CentriMag Pressure Transducers

Available for the Primary System 3 3 3 3 3

Available for the Back-Up System 31 3 3

3.1.4 CentriMag Primary Console The CentriMag Console uses single phase AC power and is capable of a flow rate of up to 9.9 LPM or maximum pressure head of 600 mmHg. 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.

1

A cart is available for the Back-Up console only when used together with a Primary Console.

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3.1.4.1 CentriMag Primary Console Front Panel The CentriMag Primary Console (Figure 4) is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data, system options, and menus. Operator adjustable alarms and parameters are accessible via the system menus.

Figure 4: Thoratec CentriMag Primary Console A Flow Probe is provided with each Primary Console. The Flow Probe is a reusable, non-patient contacting ultrasonic Flow Probe which can detect flows from 0-9.9 LPM when used in conjunction with the CentriMag Primary Console. The probe can detect retrograde flow of >40 cc/min. Retrograde flow >40 cc/min is always displayed as dashes “-.--“. A disconnected or malfunctioning probe will display blank spaces “ “.

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This sensor is compatible with 3/8” ID by 3/32” wall tubing and is a molded clip-on design for easy care and handling. 3.1.4.2 CentriMag Primary Console Back Panel The CentriMag Primary Console back panel (Figure 5) provides the required mechanical inputs and outputs needed to operate a CentriMag Blood Pump.

Figure 5: Back panel - Thoratec CentriMag Primary Console

3.1.5 CentriMag Blood Pump The CentriMag System contains a sterile, single-use, disposable, Centrifugal Blood Pump (Figure 6).. The use of magnetic levitation eliminates the need for bearings and seals in the blood pathway, therefore, minimizing blood trauma, and the potential for hemolysis and thrombus formation. The Pump is designed to move blood by centrifugal force created by the magnetically suspended rotating impeller.

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Figure 6: CentriMag Blood Pump

The flow rate is dependant on the available amount of blood to be pumped, the Pump speed (RPM), and the blood pressure at the pump outlet. The relationship between pressure and flow rate as a function of RPM can be seen in Figure 7 for the CentriMag Blood Pump as an isolated component of the Circuit.

Pressure (mmHg)

CentriMag Pump H-Q Performance (Blood Analog) Pump Only 800

2000

700

2500

600

3000

500

3500

400

4000

300

4500

200

5000

100

5500

0 1

2

3

4

5

6

7

8

Flow (LPM)

Figure 7: CentriMag Blood Pump Differential Pressure/Flow Curve Note: Actual obtainable flow is dependent on the afterload of the Blood Pump, which results from the extracorporeal circuit (e.g. oxygenator, tubing, etc.) as well as patient arterial resistance. CentriMag Primary Console Operating Manual © 2006 Thoratec Corporation – Document No. PL-0074, Rev. 00 (September 2006)

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3.1.7

CentriMag Motor

The Thoratec CentriMag Motor (Figure 8) holds the CentriMag disposable Blood Pump and drives the rotor inside the Blood Pump.

Figure 8: CentriMag Motor

This Manual describes the functions, setup and operation of the CentriMag Primary Console. A more complete description of the setup and priming of the Blood Pump can be found in the Thoratec CentriMag Blood Pump Instructions for Use. 3.1.8 CentriMag Back-Up Console The CentriMag Back-Up Console (Figure 1d) uses single phase AC power and is capable of a flow rate of up to 9.9 LPM or maximum pressure head of 600 mmHg. In addition each Back-Up Console contains a non-rechargeable, field replaceable internal battery that is capable of maintaining Back-Up Console functionality in the event of a loss of AC Power. The intended function of the CentriMag Back-Up Console is to provide basic lifesupport during a Primary Console malfunction until the Primary Console can be replaced with another Primary Console. This Manual describes the functions, setup and operation of the CentriMag Primary Console. A more complete description of the CentriMag Back-Up Console can be found in the Thoratec CentriMag Back-Up Console Operating Manual.

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3.2

Application Software Version

This Operating Manual is written for CentriMag Primary Consoles with Application Software Version 2.01 on board. The Application Software Version flashes on the Primary Console’s digital display during power up. 3.3

Indications for Use

The CentriMag® Blood Pump is indicated for use only with the Thoratec CentriMag® Console to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc.). 3.4

Contraindications for Use

This CentriMag System is 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. 3.5

Required User Supplied Items

The following items, required for use with the CentriMag® Blood pump, are or may be necessary but not provided by Thoratec: • • • • • •

Hemostats or vascular clamps Connecting tubing and adapters Oxygenator Circuit prime Circuit Filter Tubing Adapters with Luer Lock ports

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4

SPECIFICATIONS AND GENERAL DESCRIPTION

This section includes the product specifications and physical attributes of the CentriMag Primary Console. 4.1

Classification Table 3: Primary Console Classification SYMBOL

4.2

CLASSIFICATION

DESCRIPTION

Type CF – Defibrillator Proof

Equipment Type.

None None

Class 1 Continuous, internally powered

None

Not for AP or APG.

None

IPX 0 enclosure.

Equipment Classification. Mode of Operation. Not suitable for use in the presence of a flammable anesthetic mixture. Not splash proof. Do not spray cleaning agents directly on Console enclosure.

Specifications Table 4: Primary Console Specifications PARAMETER

SPECIFICATIONS

AC Power

100 – 240 VAC at 50/60 Hz, 120 W

Battery Power

20.4 VDC NiMH (17 cells), internal rechargeable battery Discharge time: 60 minutes at 5.5 LPM and 3,500 RPM Recharge time: 4 hrs to 90% charge, 5 hrs to 100% charge

Dimensions

Height: Width: Depth:

Weight

6.6 kg / 15 pounds

Pump Speed Range

0 – 5,500 revolutions per minute (RPM)

21.2 cm / 8.4 inches 26.0 cm / 10.2 inches 32.0 cm / 12.6 inches

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Table 4: Primary Console Specifications PARAMETER

4.3

SPECIFICATIONS

Pump Flow

0.0 – 9.9 liters per minute (LPM)

Serial Output

For Thoratec use only.

Electrical Safety

Earth leakage current: < 500 µA Enclosure leakage current: < 100 µA Patient leakage current: < 10 µA

Environmental Conditions

4.3.1 Shipping Conditions The following are the acceptable environmental conditions during shipping: • • •

Temperature: -35o C to 65o C. (one week maximum) Relative humidity: 0% to 95%. Atmospheric pressure: 157 – 760 mmHg.

4.3.2 Operational and Storage Conditions The following are the acceptable environmental conditions during operation and storage: • • • 4.4

Temperature: 10oC to 30oC. Relative humidity: 30% to 75%. Atmospheric pressure: 595 – 760 mmHg. EMI Considerations

Electro-magnetic interference (EMI) sources in the vicinity of the CentriMag System may interfere with Console performance. If changes occur in the operating parameters of the Console due to EMI sources, immediately remove the source of EMI or move the Console away from the source of the EMI. The CentriMag Primary Console may interfere with the operation of other equipment in close proximity. Do not place other equipment, other than a 2nd Primary or a BackUp Console, near the Primary Console. 4.5

Permanent Magnet Considerations

Permanent magnets can interfere with proper pumping operation when in close proximity with the CentriMag blood Pump and CentriMag Motor. These sources of CentriMag Primary Console Operating Manual © 2006 Thoratec Corporation – Document No. PL-0074, Rev. 00 (September 2006)

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magnetism include items such as, but not limited to, spare CentriMag Pumps and permanent DC (Direct Current) Motors. 4.6

Console Control Panel

The CentriMag Primary Console Control Panel (Figure 9) contains three rows of information/functions. Row 1 includes indicators (bars and LED’s) for the Blood Pump’s speed (RPM), flow rate (LPM), and power source (battery gauge and battery icon for battery power and plug icon for AC power). Row 2 consists of a four-line alphanumeric vacuum fluorescent display. The top two lines on the display are used to display system status. The third line is used to display the selected system parameter, and the bottom line displays the four soft keypad descriptions for the active screen. Row 3 consists of six keypads. The first keypad (furthest to the left) silences the alarm audio, and the last on the right stops the Blood Pump. The other four keypads from left to right are: menu options (MENU) Blood Pump speed adjustment (SET RPM) and menu item adjustment (DECREASE) (INCREASE).

Figure 9: Console Control Panel

The symbols used on the Console and their meanings are listed in Table 5.

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Table 5: Symbols on the Primary Console SYMBOL

NAME

DESCRIPTION

Alarm Acknowledge

Depressing this keypad signals the Primary Console that the user is aware of an alarm/alert condition(s). The Primary Console will silence the audio alarm/alert indicator for a fixed period depending upon the nature of the alert/alarm.

Menu

Depressing this keypad will allow the user to select system settings to view or modify (e.g., flow alarm levels, audio volume, language, etc.).

Set Pump Speed (RPM)

When SET RPM is displayed above this keypad, on the alphanumeric display screen, depressing this keypad will allow adjustment of the Blood Pump speed. When EXIT is displayed above this keypad on the alphanumeric display, depressing this keypad will disable the ability to adjust Blood Pump speed and maintain the Blood Pump speed at the displayed rate.

Decrease

This keypad is used to select/modify the value for the displayed item to be adjusted.

Increase

This keypad is used to select/modify the value for the displayed item to be adjusted.

Controls – Front Panel

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Table 5: Symbols on the Primary Console SYMBOL

NAME

DESCRIPTION

Emergency Pump Stop

When depressed for at least 2 seconds, this keypad will cause the Pump RPM to immediately be set to zero causing the Blood Pump to stop.

ON/OFF Switch

Power switch located on the lower the right side panel of the Primary Console. The power switch is recessed, and covered with hinged plastic cover to prevent inadvertent actuation. Switching to off disables all functions and displays except for battery charging function.

Indicators – Front Panel

Pump Speed

Flow Rate

Blood Pump speed (RPM) Display: The Top portion of the Blood Pump Speed display is an analog representation of the Blood Pump Speed (shown as dashes); one LED (one dash) is equivalent to 550 RPM. The bottom portion of the Blood Pump Speed display is a 4-digit display that provides a numeric representation of the Blood Pump speed in RPM. Flow rate (LPM): The Top portion of the Flow Rate Display is an analog representation of the Blood Pump Flow (shown as dashes); one LED (one dash) is equivalent to 1.0 LPM. Note that an additional dash is displayed when entering the next “liter” of flow. The bottom portion of the Flow Rate Display is a 3-digit numeric display that provides a digital representation of the Blood Pump Flow in LPM.

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Table 5: Symbols on the Primary Console SYMBOL

NAME

Power Source

DESCRIPTION AC plug icon indicator (GREEN DOT) illuminates when operating under AC power. Battery icon (GREEN DOT) illuminates when the Primary Console is operating under battery power. Battery charge LED indicates charge remaining in the Primary Console’s internal battery. Full battery charge is indicated until nominal battery charge falls below 80%.

Connections – Back Panel

Motor Power

Power Entry Module (AC Power and Fuses)

Connection for power to Motor. Red dot located on top of connector facilitates alignment of Motor LEMO connector.

Connection for Primary Console to AC power and fuse box. Use only T4A 250V fuses only.

Flow Probe connector

15-Pin connection for the Flow Probe.

Equipotential Bonding Post accompanied by its applicable international Symbol (IEC 417-5021)

The Equipotential Bonding Post (EBP) provides a low impedance electrical safety common connection point.

RS-232 Connector

The RS-232 Connector is reserved exclusively for Thoratec use.

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