Medtronic R5400022 Operator's Manual

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PERFORMER™CPB

An Advanced Extracorporeal Circulatory Support System

Operator’s Manual

Distributed Exclusively by Medtronic, Inc.

Manufactured by RanD S.r.l. Medolla (MO) Italy

Explanation of symbols on package labeling

Refer to the package label to see which symbols apply to this product

0123

Conformité Européenne (European Conformity). This symbol means that the device fully complies with European Council Directive MDD 93/42/EEC (14 June 1993, concerning medical devices) and amendments.

Caution, Consult Accompanying Documents

Serial Number

Lot Number

Quantity

For US Audiences Only

Date of Manufacture

Temperature Limitation

Humidity Limitation

Catalog Number

Manufacturer

Fuse

Alternating Current

Type BF Equipment

High Voltage

Medical equipment with respect to electrical shock fire, and mechanical hazards only in accordance with UL 60601-1/CAN/CSA C22.2 No. 601.1, IEC 60601-2-16 71NL.

This Way Up

Fragile, Handle with Care

xx Kg

MAX

Maximum Weight

Do not dispose of this product in the unsorted municipal waste stream.

Danger: Risk of explosion if used in the presence of flammable anesthetics.

Equipotentiality

Level Sensor

Remote Tube Clamp

VARD

Operator’s Manual i

Bio-Pump

Flowmeter/ABD

Class II (Double Insulated) Equipment

Open Here

Warning, Crushing Hazard: Finger

Pneumatic Pressure Range

Atmospheric Limitation

ii Operator’s Manual

Table of Contents

1 Introduction 1-1

System Description 1-2

System Overview 1-2

Indications for Use 1-5

Contraindications 1-5

Warnings 1-5

Cautions 1-9

2Safety2-1

Safety Standards 2-2

Disposables and Accessories 2-2

Main Power Supply Failure 2-2

Electromagnetic Disturbance 2-3

Elimination of the Disposable Material 2-3

End of Life Disposition 2-3

Calibration 2-3

Technical Documentation 2-3

Replacing Fuses 2-3

Equipotential Connection 2-4

Battery Pack Disposal 2-4

3 Technical Specifications 3-1

General Data 3-2

Technical Features 3-3

Electromagnetic Emissions and Immunity Declarations 3-6

Monitoring System for Hematocrit, Temperature and O

Temperature Probes 3-11

Battery Supply System (UPS) 3-11

IEC 60601-2-16 Compliance Chart 3-12

Saturation 3-10

4 Installation 4-1

Installation 4-2

Installation Checklist and Commissioning 4-3

5 Instructions for Use 5-1

Console 5-2

Roller Pump, Roller Inserts, Tube Inserts, and Tubing 5-6

System Configuration 5-16

System Start-up 5-35

Main Run Screen 5-41

Timers 5-46

Cardioplegia 5-49

AAR Controller - Venous Air Removal Device (Resting Heart mode only) 5-58

Air Detection 5-63

Operator’s Manual iii

Table of Contents

Level Sensing System (Bio-Pump CPB mode only) 5-67

AutoClamp System (Bio-Pump CPB mode only) 5-73

Pressure Mode Selection 5-84

Venous Saturation and Hematocrit Monitoring 5-90

Options Menu Screen 5-94

Servo (Resting Heart mode only) 5-104

Preparing for Cardiopulmonary Bypass Checklist 5-109

Initiating Extracorporeal Support Checklist 5-112

6 Cleaning and Maintenance 6-1

Cleaning 6-2

Maintenance 6-2

7 Troubleshooting 7-1

General Information 7-2

Emergency Procedures 7-4

Alarms 7-20

Alerts 7-27

8 Warranty 8-1

IMPORTANT NOTICE - LIMITED WARRANTY 8-2

IMPORTANT NOTICE - LIMITED WARRANTY 8-3

A Index A-1

iv Operator’s Manual

PERFORMER™ CPB 0

Operator’s Manual

System Description 1-2

System Overview 1-2

Indications for Use 1-5

Contraindications 1-5

Warnings 1-5

Cautions 1-9

Introduction

Operator’s Manual 1-1

Chapter 1

System Description

The Performer™ CPB System, hereafter referred to as the Performer CPB, is an electromechanical extracorporeal support device used during cardiopulmonary bypass procedures. It is an integrated console that can provide total circulatory support of the cardiopulmonary system using the Medtronic Blood Pump, hereafter referred to as the Bio-Pump.

System Overview

Bio-Pump® Centrifugal

Total extracorporeal support of the cardiovascular system is accomplished by using the Bio-Pump Performer CPB for generating arterial flow up to 10.0 liters per minute (L/min). Bio-Pump flow is achieved by adjusting the pump speed RPM knob on the front panel of the Performer CPB console. Flow measurement is accomplished using a reusable ultrasonic flow transducer that is noninvasively attached to the arterial line of the extracorporeal circuit. The detected flow is displayed on the front panel of the console (red LED) and on the Main Run Screen of the Central Information Display (CID). The pump speed RPM knob has a minimum RPM mechanical stop, or detent, that prevents an unintentional reduction of RPM below 2000. The user must press down on the detent lever while turning the knob counterclockwise to purposefully reduce the RPM below 2000. The minimum RPM detent lever does not affect increasing the RPM.

Integral to the Performer CPB are four roller pumps, each with an independent Start/Stop button, a 3-turn roller speed control knob and a LCD for monitoring flow or RPM. The roller pumps are indicated for moving fluids through an extracorporeal circuit that incorporates a flexible tube. The roller pumps are not indicated for use in supporting flow through arterial circuits.

Two small roller pumps (PM4 and PM3) generate low flow for cardioplegia delivery, hemoconcentration, or other auxiliary applications. PM4 is a deep-well pump capable of accommodating two tubes of same or different dimensions and is capable of a maximum flow of 1.1 L/min. PM3 accommodates one tube and is capable of a maximum flow of 0.6 L/min. PM3 and PM4 can be configured via the CID so that both pumps operate in tandem, with PM4 designated as the master pump and PM3 designated as the slave pump. The master pump Start/Stop button and pump speed RPM knob operate both pumps.

Centrifugal Blood Pump. The Bio-Pump is the exclusive device on the

Two large roller pumps (PM1 and PM2) generate flow for cardiotomy suction, left heart venting, or auxiliary application. PM1 is a low torque/high speed roller pump with a maximum flow capacity of 3.7 L/min. PM2 is a high torque/mid-flow roller pump with a maximum flow capacity of 1.5 L/min.

The interchangeable roller pump inserts are factory calibrated for providing optimal occlusion for standard sizes of polyvinyl chloride (PVC) tubing available for medical use. Factory-calibrated roller pump inserts are also available when using 2 tubes in a single raceway.

The Performer CPB provides perfusion monitoring via:

1-2 Operator’s Manual

Pressure monitoring transducers for up to 8 pressures including venous line, arterial line, cardioplegia delivery, AAR suction, vent line, sucker line, syringe, and one user-defined.

Introduction

System Overview

Temperature monitoring using YSI™1 Series 400 probes for 8 temperatures including venous line, arterial line, cardioplegia delivery, and the remainder user defined.

Flow monitoring for the arterial line using a reusable Transonic

™2

ultrasonic flow probe, which noninvasively connects directly to the arterial line tubing. This flow probe also serves to detect backflow in the arterial circuit. Flow data combined with patient body surface area entered in the CID also provides for continuous monitoring of cardiac index.

Oxygen saturation and hematocrit monitoring using an opto-electric sensor, which couples with a dedicated disposable cuvette that is integrated into the extracorporeal circuit. This data, in combination with the information obtained from the flow transducer, is used to calculate and display oxygen consumption on the CID.

Timers for pump time, clamp time, and cardioplegia delivery times and intervals.

The CID enables the user to interact with the Performer CPB equipment. It consists of a 30.73 cm (12.1 in) color graphic display (256 colors, 800 x 600 pixel) in combination with a touch screen system to activate the various functions represented on the screen. The display is divided into well-defined zones for the individual perfusion modes and uses unique graphic pictures and icons to display information. Critical information areas are always visible. The touch screen display allows the user to:

■

display all desired perfusion parameters

■

input patient information

■

configure pump responses to activation of safety devices and events that occur during bypass

■

set safety alert and alarm limits

■

display graphical trending of data

■

select cardioplegia delivery modes

■

read message alarms and warnings

■

select audible alert and alarm tones

The CID and the console incorporate distinct visual and audible cues intended to elevate the user's awareness when a safety sensor is activated and when user-defined or default operational limits of a system are exceeded. The Performer CPB enables the user to configure integrated safety links between the following safety sensors and the Bio-Pump and the roller pumps:

■

Air Bubble Detection (ABD) of macro-air in the arterial circuit is integral to the ultrasonic flow monitoring system. The system can be configured by the user to cause the Bio-Pump to either Stop or Coast in response to this sensor being activated and prevent transmission of air to the patient. The user can also configure this safety link to not change the Bio-Pump function, but only produce visual and audible alarm cues.

■

Air bubble detection of macro-air in the cardioplegia circuit, using an ultrasonic transducer mounted to the side of the console that couples directly to the cardioplegia delivery tubing. The user can configure the cardioplegia delivery pump (PM4) to either Stop or Pause in response to this event and prevent transmission of air to the heart. The user can also configure this safety link to not change the roller pump function but only produce visual and audible alarm cues.

YSI™ is a registered trademark of YSI Incorporated.

Transonic™ is a registered trademark of Transonic Systems Inc. Corporation.

Operator’s Manual 1-3

Chapter 1

System Overview

■

Active Air Removal (AAR) technology integral to the Performer CPB is used in conjunction with a dedicated disposable Venous Air Removal Device (VARD) for venous air sensing and automatic removal. This prevents air entering the venous line from reaching the Bio-Pump and potentially being transmitted to the patient. The Active Air Removal (AAR) technology with the VARD is only utilized when operating the Resting Heart mode.

■

Level Detection utilizes a pair of level sensors to monitor changes in fluid or blood volume in reservoirs. The system can be configured by the user to cause the Bio-Pump to either Stop or Coast in response to a level sensor being activated, preventing emptying the reservoir and transmitting air into the circuit. The user can also configure this safety link to not change the Bio-Pump function, but only produce visual and audible alarm cues. The level detection system is only utilized when operating in the Bio-Pump CPB mode.

■

An AutoClamp System utilizes a pneumatically-powered Remote Tube Clamp (RTC) that is placed on the arterial line and serves to prevent retrograde flow from the aorta into the venous reservoir if the Bio-Pump run mode changes. When the Bio-Pump enters either the STOP or COAST mode, or the pump speed is manually reduced to 2000 RPM, there exists the potential for arterial retrograde flow and entrainment of air into the arterial line from around the aortic cannulation site. This poses a hazard to the patient if the pump is restarted before air is removed. The AutoClamp System can be configured to automatically clamp the arterial line when the Bio-Pump speed changes, prevent retrograde flow and thereby prevent the potential to entrainment air around the aortic cannulation site. The AutoClamp System is only utilized when operating in the Bio-Pump CPB mode.

■

Pressure transducers enable user-defined alert and alarm limits for arterial line pressures, venous line pressures, cardioplegia pressures, as well as the individual roller pump pressures.

The Performer CPB provides an uninterruptible power supply (UPS) that will provide battery power to operate the system for a minimum of 30 minutes with a fully loaded system (see page 5-44) in the absence of line power.

Additional user conveniences include:

■

Cardioplegia delivery configuration options to select automatic shut off of the cardioplegia pump to user-defined volume or time delivery parameters and a user-defined option for two-pump blood and drug proportioning from 0:1 (pure drug) to 15:1.

■

Graphic trending of flow, cardiac index, venous saturation, hematocrit, pressure, and temperature data.

■

Capability to auto-regulate the speed of the Bio-Pump to maintain a desired venous line pressure. This function is particularly useful when operating the Medtronic

Resting Heart™ System and optimizing the relationship between

blood flow and left heart emptying.

■

An integrated printer to generate hard copy records.

■

A removable data storage card that allows perfusion and system information to be stored electronically and then later formatted for generating reports.

■

Electric powered height adjustment for optimal operation, transport, and storage.

1-4 Operator’s Manual

Indications for Use

The Medtronic® Performer™ CPB Advanced Extracorporeal Circulatory Support System is indicated for use up to 6 hours in the extracorporeal circulation of fluids for cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The Bio-Pump an extracorporeal perfusion circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours).

Contraindications

The device is not designed, sold, or intended for use except as indicated.

The centrifugal pump is contraindicated for use as a cardiotomy suction device.

Warnings

Introduction

Indications for Use

Centrifugal Blood Pump is indicated for use in pumping blood through

General

■

The user must read and understand all information in the Operator's Manual prior to use. Failure to read and follow all instructions, or failure to observe all stated warnings, could cause serious injury or death to the patient.

■

Only trained and qualified medical personnel should operate and monitor the Perfor mer CPB.

■

Use the system and any attached devices according to the manufacturer's instructions and good medical practice.

■

The system is qualified only for durations appropriate to cardiopulmonary bypass procedures. It has not been qualified, either through in-vitro, in-vivo, or clinical studies, for use beyond 6 hours.

■

The Performer CPB enables the user to change the configuration of the default factory settings. Reconfiguration in regards to how components respond to events and assurance that users are properly trained to operate the Perfusion Screens must be appropriately controlled by the user institution. Failure to establish such controls may result in user error that could result in patient injury or death.

■

Following standard practices for electronic devices, closely monitor the system when exposure to intense electrical noise or fluctuating line voltage occurs. Strong electromagnetic fields emitted from other equipment in the operating room (OR) (internal and external defibrillators, electrocautery devices, etc) or fluctuations in the alternating current (AC) power line voltage may compromise performance or damage the equipment.

■

Portable and mobile radio frequency (RF) communication devices may affect the operation of this system. (See “Electromagnetic Emissions and Immunity Declarations” on page 3-6.)

■

A standby Bio-Console® Extracorporeal Blood Pumping Console should be available during cardiopulmonary bypass procedures.

■

Maintain a minimum Bio-Pump speed or clamp the pump outlet line to prevent backflow.

■

Do not kink the VARD sensor cable.

Operator’s Manual 1-5

Chapter 1

Warnings

■

Do not allow fluids to come into contact with the cable connections.

■

To prevent backflow of the patient's blood when the pump outlet tubing is open, establish and maintain a minimum pump speed that overcomes line and patient resistance. Failure to do this could allow retrograde flow and exsanguinate the patient.

■

All gaseous bubbles have the potential for gaseous emboli and must be dealt with carefully. Use of Safety Devices (Arterial Line Air Bubble Detector, VARD, Level Detection, AutoClamp) and Safety Systems (Bio-Pump Backflow Alert) is recommended to aid in the detection and elimination of gaseous bubbles in the extracorporeal circuit.

■

When handcrank operation of a roller pump is necessary due to a failure of the motor or motor controller, the roller pump digital display may remain illuminated. Any RPM/flow values that are being displayed will not correlate to the manual RPMs or flow generated using the handcrank.

■

A fluid isolator is necessary in the pressure monitoring line to prevent contact of sterile fluid path with the instrument and damage to the instrument and pressure system.

■

Do not bypass the fluid isolator/filter in the pressure lines for the pressure connectors (PR1 through PR8, ALP, and VLP) or fluid could enter the transducer and damage internal components.

■

Do not introduce fluid into the male pressure luer connections on the console.

■

Do not connect the external temperature probes in conjunction with electrocautery usage; this may compromise the temperature values measuring.

■

The device has been designed and tested in conformity with the Electro-Magnetic Compatibility standard EN60601-1-2 (2003). It is advisable, however, to avoid its use in the presence of electromagnetic fields or other equipment causing interference (eg, cellular phones). Special information regarding installation, use, and precautions are described in “Electromagnetic Emissions and Immunity Declarations” on page 3-6.

■

The utilization of other manufacturers' probes (eg, flow and temperature) may jeopardize the performance of the device and, as a consequence, the measurement reliability.

■

The equipment is not protected against defibrillator discharges.

AAR Controller

AutoClamp System

1-6 Operator’s Manual

■

Do not operate the Active Air Removal (AAR) system with device or components other than the Medtronic

Resting Heart™ Module. There are no safety or performance data known to Medtronic that establish compatibility of any other manufacturer's device or components with the AAR system. Any substitution of components becomes the responsibility of the user. Such substitution will void Medtronic's warranty and the user will bear full responsibility for any adverse consequences stemming from such use.

■

Do not use the integrated AAR Controller until proper operating conditions are verified. Prior to each use, it is the responsibility of the user to determine that the system is in proper operating condition as described in this manual.

■

To prevent backflow of the patient's blood when the pump outlet tubing is open, establish and maintain a minimum pump speed that overcomes line and patient resistance. Use the AutoClamp System on the arterial line. Failure to do this could allow retrograde flow and introduce air into the arterial circuit.

Introduction

Warnings

■

Prior to configuring the Arterial AutoClamp to CLOSE when the Bio-Pump enters the COAST mode, it is the user's responsibility to test their extracorporeal circuit and confirm the conduct of perfusion at their institution does not generate arterial backflow when the Bio-Pump enters the COAST mode or the Bio-Pump speed is manually reduced to the “detent” position.

■

If the Bio-Pump enters the Coast Mode in response to the “AIR DETECTED BY ABD” alarm, pump RPM will remain at 2000 and will not automatically ramp up after the air is no longer detected by the ABD or after the ABD is turned off. Flow can only be resumed manually after careful assurance that air has been completely removed from the arterial circuit.

■

If the Bio-Pump enters the Coast Mode in response to the “AIR DETECTED BY ABD” alarm and the AutoClamp is configured to CLOSE, the AutoClamp will not automatically OPEN after Bio-Pump flow is resumed. The user must manually press the AutoClamp button on the Main Run Screen to open the clamp after careful assurance there will be forward flow.

■

The Self Test must be performed prior to each use of the device. If the AutoClamp System does not operate as described during the Self Test, do not use the AutoClamp System. Contact Medtronic Service.

■

Resume flow only after careful assurance there is no air in the arterial circuit.

■

Ensure the air pressure to the AutoClamp System is within the range specified in Chapter 3.

Battery/UPS

■

If a partially charged battery is used, there may be less than 30 minutes of battery power available.

■

When the Uninterruptable Power Supply (UPS) converts the system to battery power, ALL pumps, pump functions, safety systems, alerts, alarms, monitors, controls, the Pinch Valve and the Central Information Display (CID) are active and function the same as when the system is on AC power.

Main Power Switch

■

Ensure that the Main Power switch is off before storage, inspection, cleaning, and preparation for use to disable both the battery power and wall AC power.

Central Information Display (CID)

■

If the CID fails during a procedure, the Performer CPB can be operated through the local controls for the roller pumps and the Bio-Pump.

■

If the CID fails during a procedure, the sensors that have safety connections with the Bio-Pump will remain enabled. The sensors that detect and measure blood flow, Arterial Line Pressure (ALP), Venous Line Pressure (VLP), Venous Saturation (SvO2), Hematocrit (Hct), Revolutions Per Minute (RPM), and Cardioplegia Pressure can be displayed by scrolling through the Liquid Crystal Display (LCD) display on the Bio-Pump control panel on the front of the console.

■

If the CID fails during a procedure, DO NOT turn the system power off as this will cause all settings and device assignments to be lost.

■

The CID must be in the Home Screen for data to be downloaded into the CompactFlash allow a minimum of 10 seconds for the data download to complete before removing the CompactFlash

®3

memory card. After the CID is changed to the Home Screen,

memory card.

CompactFlash® is a registered trademark of SanDisk Corporation.

Operator’s Manual 1-7

Chapter 1

Warnings

Tubing

Roller Pump

■

Using the Pre-Cardiopulmonary Bypass Parameters Screen with the alpha-numeric keyboard during the conduct of cardiopulmonary bypass will cover essential perfusion and cardioplegia delivery information screens. Enter data prior to initiating bypass. Do not use during bypass.

■

Tubing must not be reversed in the roller pump as air embolism may occur.

■

Use only tubing of the material and sizes specified for this system.

■

Set the roller pump to the Stop Mode before installing tubing.

■

The roller pump safety cover interlocks are not enabled until after the Resting Heart™ Screen is opened. Ensure that the roller pump safety covers remain closed during the Power On Self-Test (POST).

■

The roller pump safety cover interlocks are not enabled until after the Resting Heart™ Screen is opened. Ensure that the roller pump safety covers remain closed when in the Emergency Mode.

■

The roller pump safety cover interlocks are not enabled until after the Resting Heart™ Screen is opened. Ensure the roller pump safety covers remain closed if roller pump function is required before enabling the Resting Heart™ Screen.

Handcrank

■

If handcrank operation is necessary due to the loss of AC and battery power, flow detection and safety systems are inoperable. Closely monitor the circuit to prevent introduction of air.

Bio-Pump

■

If air enters the Bio-Pump, stop perfusion as gaseous emboli may be introduced into the patient.

■

If the Bio-Pump stops, immediately clamp the arterial line and venous line. Check for air in the arterial line that may have resulted from backflow. If air is visible, remove from the arterial circuit before resuming bypass.

■

If the Bio-Pump enters the Coast Mode in response to the “AIR DETECTED BY ABD” alarm, pump flow will remain at 0.5 L/min and will NOT automatically ramp up after the air is no longer detected by the ABD or after the ABD is turned off. Flow can only be resumed manually after careful assurance that air has been completely removed from the arterial circuit.

Power On Self-Test (POST)

■

Bypassing the POST when a system has failed may cause error messages or malfunction during use.

■

If the POST repeatedly produces a FAILED indication, contact a Medtronic service representative.

Air Bubble Detector (ABD)

■

A gray icon (with a red X) for the Arterial Line Air Bubble Detector icon indicates the sensor is DISABLED and will not generate an alarm if air enters the arterial circuit.

1-8 Operator’s Manual

Cautions

Introduction

Cautions

■

The Air Bubble Detector (ABD) sensor must be positioned at a sufficient distance from the patient to allow the air detection system sufficient time to respond before air can reach the patient.

■

The ABD sensor latch must be completely closed to secure the sensors to the tubing.

■

The ABD sensor must be positioned so the cable is between the tubing and the floor.

■

The performance of the ABD must be verified before each use.

■

A gray icon (with a red X) for the Cardioplegia (CPG) Air Bubble Detector icon indicates the sensor is DISABLED and will not generate an alarm if air enters the cardioplegia circuit.

■

Do not use sharp instruments on the CID, Bio-Pump control panel scroll arrows, or the roller pump Start/Stop button as these may damage the device. Restrict touching the screen with fingers only.

■

Installing the Bio-Pump with the motor revolving may damage the Bio-Pump.

■

When assembling the Bio-Pump Centrifugal Blood Pump, Model BPX-80, for use with the Performer CPB, do not use alcohol or alcohol-based fluids. Do not expose to chemical agents as they may affect the integrity of these devices. Anesthesia solutions such as FORANE

are known to degrade polycarbonate plastics. Avoid

contact of these solutions with the BPX-80 Bio-Pump.

■

Using the Bio-Pump beyond labeled recommendations may result in failure of the centrifugal blood pump, reduced pumping capacity, leaks, excessive blood trauma, and degradation or corrosion of blood contact materials, which may pass through the blood to the patient.

■

Refer to the instructions included with the Medtronic® Resting Heart™ System or specific manufacturers’ disposable circuits.

■

Maintain a minimum pump speed or clamp the circuit's arterial line to prevent arterial backflow.

■

If the pressurized gas fails or the air hose is disconnected, the Remote Tube Clamp (RTC) will close.

■

Do not drop the O2Sat/Hct sensors as shock may damage the sensor.

■

Do not adjust the occlusion setting on the roller pump insert; doing so will void the warranty.

■

Ensure the castor brakes are engaged before use.

■

When transporting the machine, reduce the equipment’s height to the lowest position to avoid tipping.

■

Only ship the Performer CPB in a Medtronic-approved crate. Contact your service personnel for the correct procedure.

■

After each use, clean the device as per the instructions on page 6-2 and ensure all components are in proper working condition.

FORANE® is a registered trademark of ATOFINA.

Operator’s Manual 1-9

Chapter 1

Cautions

1-10 Operator’s Manual

Safety Standards 2-2

Disposables and Accessories 2-2

Main Power Supply Failure 2-2

Electromagnetic Disturbance 2-3

Elimination of the Disposable Material 2-3

End of Life Disposition 2-3

Calibration 2-3

Technical Documentation 2-3

Safety

Replacing Fuses 2-3

Equipotential Connection 2-4

Battery Pack Disposal 2-4

Operator’s Manual 2-1

Chapter 2 Safety Standards

ATTENTION: The Performer CPB must be operated only by skilled personnel trained for this task and in conformity to the present Operator’s Manual.

Safety Standards

The Performer CPB equipment complies with the essential requirements of the Directive on Medical Devices 93/42 EEC (CE 0123)

The Performer CPB equipment also complies with the following international standards:

Manufacturing safety, electrical safety:

■

Functional safety:

■

IEC 60513

IEC 60529

EN 60601-1

EN 60601-1-1 (2003)

ISO 14971

EN 60601-1-4

EN 60601-1-4/A1 (2000)

EN 60601-2-16

Electromagnetic compatibility:

■

EN 60601-1-2 (2003)

Disposables and Accessories

Use only disposables and accessories approved by Medtronic for use with the Instrument. The use of other manufacturers' disposables and accessories has not been validated by Medtronic and will void the warranty on the Instrument and may jeopardize the functionality of the Instrument, possibly compromising patient safety.

Used accessories and parts may be used with the Instrument only when their suitability for use has been established and certified, from the technical safety point of view, by a person or entity authorized by Medtronic to test their performance with the Instrument.

Main Power Supply Failure

In case of a main supply failure, fully-charged backup battery will allow treatment with a fully loaded system to continue for a minimum of 30 minutes (see page 5-44).

2-2 Operator’s Manual

Electromagnetic Disturbance

The Performer CPB has been designed and tested to comply with the requirements and tests of the electro-magnetic compatibility standard EN60601-1-2 (2003). It is advisable, however, to avoid its use in the presence of strong electromagnetic fields radiated from other equipment in the operating room (ie, defibrillators and electrocautery devices) that may cause interference.

Special information regarding installation, use, and precautions are described in “Electromagnetic Emissions and Immunity Declarations” on page 3-6.

The use of any accessory, probes, or cables other than those specified in this document, including replacement parts, may result in either increased emissions or decreased immunity of the Performer CPB.

Elimination of the Disposable Material

The disposables used in each treatment shall be disposed of using specific containers and in conformity with local norms.

Safety

Electromagnetic Disturbance

End of Life Disposition

Do not dispose of this product in the unsorted municipal waste stream. Follow local regulations for proper disposal. Please refer to Medtronic web site http://recycling.medtronic.com for proper disposal guidance to ensure compliance with the European Union’s Waste Electrical and Electronic Equipment (WEEE) Directive.

Calibration

The calibration shall be performed only by authorized personnel.

Technical Documentation

The Service Manual, with electrical schemes, calibration procedures, and component lists, will be provided upon request, for exclusive use by authorized, trained personnel.

Replacing Fuses

No auto-restoring fuses are present on the Performer CPB equipment; only internal and external non-restoring fuses.

The replacement of a malfunctioning internal fuse(s) must be performed by authorized, trained personnel.

The replacement of a malfunctioning external fuse(s) must be performed by using the correct fuse(s) type as indicated by the external label and by the manufacturer (see “General Data” on page 3-2).

Operator’s Manual 2-3

Chapter 2 Equipotential Connection

Equipotential Connection

Specific connection for the potential equalization is available on the Performer CPB in case the local regulations require “potential compensation” by means of connection to the potential compensation network.

The potential equalization connection is also recommended if other pieces of equipment are used in combination with the Performer CPB.

Battery Pack Disposal

The life of the rechargeable battery packs is foreseen up to 4 years (depending on the number of charge/discharge cycles and on correct use). After this period, battery replacement and disposal is provided by authorized, trained personnel.

2-4 Operator’s Manual

Technical Specifications

General Data 3-2

Technical Features 3-3

Electromagnetic Emissions and Immunity Declarations 3-6

Monitoring System for Hematocrit, Temperature and O2 Saturation 3-10

Temperature Probes 3-11

Battery Supply System (UPS) 3-11

IEC 60601-2-16 Compliance Chart 3-12

Operator’s Manual 3-1

Chapter 3

General Data

STATEMENT OF CONFORMITY AND CLASSIFICATION

The equipment is a Class IIB active medical device in conformity with Annex IX of the European Council Directive MDD 93/42/EEC on Medical Devices.

The equipment is CE marked according to the Annex 2.3 of the European Council Directive MDD 93/42/EEC on Medical Devices.

Electrical Data

Classification (as for EN60601-1) Class I, type BF

Operation Mode Continuous

Voltage 100 to 240 VAC ± 10%

Frequency 50 to 60 Hz ± 10%

Current max. 6 A (100 to 120V)

max. 3 A (220 to 240V)

Power absorption max. 600 VA

Earth leakage current < 300 µA

Patient leakage current < 100 µA

Potential equalization Connector available

External fuses (type 5 x 20) 2x F6.3A/250V (100 to 120V)

2x F3.15A/250V (220 to 240V)

Power Cord “Hospital Grade” type

Max. 3 m length

10A, 125V (North America)

10A, 250V (Europe)

Ingress Protection (IP code as for IEC 60529)

Environmental Operating Conditions

Temperature +10°C to +40°C

Relative humidity 30% to 75% (noncondensing)

Atmospheric pressure 700 to 1060 mBar

Transport and Storage Conditions

Temperature -20°C to +60°C

IP 21: protected against solid foreign objects of 12 mm diameter and greater; protected against drop water.

3-2 Operator’s Manual

Relative humidity 10% to 90% (noncondensing)

Atmospheric pressure 700 to 1060 mBar

Interface

External Motor Drive (Bio-Pump) 10-pin LEMO

VARD Sensor 10-pin LEMO

®1

(EGG.3B.310.CLL)

(EGG.1B.310.CLL)

Flow Probe / ABD 15-pin D-SUB

Level Sensors 7-pin LEMO

Auto Clamp 8-pin LEMO

Serial interface RS232 / RS485 (5 KV opto-isolated)

Dimensions and Weight

WxDxH 500 x 560 x 1000 - 1400 mm

Weight Approximately 90 kg

LEMO® is a registered trademark of LEMO USA, Inc.

Technical Features

9-pin D-SUB

Technical Specifications

(EGG.1B.307.CLL)

(EGG.2B.308.CLL)

Technical Features

Pump PM1

Unidirectional peristaltic pump with manual operating system

■

Flows

Up to 3.7 L/min (9.5 mm (3/8 in) pump segment)

■

Up to 3.7 L/min (6.4 mm (1/4 in) and

6.4 mm (1/4 in) pump segments)

■

Up to 1.8 L/min (6.4 mm (1/4 in) pump segment)

Maximum tolerance ± 10%

Pressure range within tolerance -150 to +500 mm Hg

Protection system

■

Feedback with rotation signal detected on the encoder.

■

Open-cover sensor (and subsequent pump blockage).

Pump PM2 Unidirectional peristaltic pump with manual

operating system

■

Flows

Up to 1.5 L/min (9.5 mm (3/8 in) pump segment)

■

Up to 1.5 L/min (6.4 mm (1/4 in) and

6.4 mm (1/4 in) pump segments)

■

Up to 0.8 L/min (6.4 mm (1/4 in) pump segment)

Maximum tolerance ± 10%

Pressure range within tolerance -150 to +500 mm Hg

Protection system

■

Feedback with rotation signal detected on the encoder.

■

Open-cover sensor (and subsequent pump blockage).

Pump PM3 Unidirectional peristaltic pump with manual

operating system

■

Flows

Up to 0.6 L/min (6.4 mm (1/4 in) pump segment)

■

Up to 0.16 L/min (3.2 mm (1/8 in) pump segment)

Maximum tolerance ± 10%

Pressure range within tolerance -150 to +500 mm Hg

Operator’s Manual 3-3

Chapter 3

Technical Features

Protection system

■

Feedback with rotation signal detected on the encoder.

■

Open-cover sensor (and subsequent pump blockage).

Pump PM4 Unidirectional peristaltic pump with manual

operating system

■

Flows

Up to 1.1 L/min (6.4 mm (1/4 in) and

6.4 mm (1/4 in) pump segments)

■

Up to 0.7 L/min (6.4 mm (1/4 in) and 3.2 mm (1/8 in) pump segments)

■

Up to 0.6 L/min (6.4 mm (1/4 in) pump segment)

Maximum tolerance ± 10%

Pressure range within tolerance -150 to +500 mm Hg

Protection system

■

Feedback with rotation signal detected on the encoder.

■

Open-cover sensor (and subsequent pump blockage).

Pressures (PR1, PR2, PR3, PR4,

Electronic measurement by means of sensors

PR7, PR8)

Operating range -500 to 500 mm Hg

Maximum tolerance ± 5 mm Hg from -200 to 500 mm Hg

± 10 mm Hg from -500 to -200 mm Hg

Protection system Test at time T1 (start-up self-tests)

Pressures (VLP, ALP) Electronic measurement by means of sensors

Operating range -500 to +750 mm Hg

Maximum tolerance ± 5 mm Hg from -200 to 500 mm Hg

± 10 mm Hg from -500 to -200 mm Hg and from 500 to 750 mm Hg

Protection system Test at time T1 (start-up self-tests)

Note: The VLP and ALP pressure inputs have redundant protective pressure transducers.

Flow Meter Ultrasonic transit-time type

Tubing 9.5 mm (3/8 in) ID x 2.4 mm (3/32 in)

6.4 mm (1/4 in) ID x 1.2 mm (1/16 in) (Not yet implemented.)

Accuracy ± 10% (1.0 to 7.0 L/min)

± 20% (-0.15 to 1.0 L/min)

Flow range 9.5 mm (3/8 in) ID x 2.4 mm (3/32 in) ➝ 1.0 to 7.0

L/min

6.4 mm (1/4 in) ID x 1.2 mm (1/16 in) (Not yet implemented.)

Air Bubble Detector (ABD)

Sensitivity Single bubble 0.1 mL (5000 Micron) to 0.3 mL of air

at 7.0 L/min flow, 37°C, blood

3-4 Operator’s Manual

Technical Specifications

Technical Features

Cardioplegia Air Sensors Ultrasound detection system

Sensitivity 0.5 mL bubble volume at 500 mL/min

Safety system Automatic: self-test performed every 10 minutes

during the therapy

Fluid-In-Line Sensors (FIL) Ultrasound detection system

Sensitivity Able to detect presence of fluid in suction line

UPS System Uninterruptable Power Supply

Inlet voltage 24 V

Outlet voltage 24 V

Nominal current 6 A

Autonomy Minimum 30 min. (with fully loaded system - see

Buffer Battery Pack

Type 2x12V - 9 A/h

Recharging time 6 hours

Replacement 4 years max.

Buzzer Sound buzzer for alarms

Type Uninterrupted sound

Current 0.3 to 8.3 mA

Sound level > 60 dB a 1 m

Frequency 2500 Hz

External Communication Interface

Format Master-Slave Binary Communication

Cable RS-485/USB

Communication parameters:

Baud Rate Bits Number Parity Stop Bit

Transmission Interval 1 second or greater

page page 5-44)

57800 8 Null 1

Printer Fixed-head thermal printer

Columns 52 … 104 (according to the character set)

Printing speed 3.5 cm/sec

Lines/sec 10

Character set extended ASCII

Paper width 111.5 mm

Power supply 24 V DC

Consumption 3.5 A max

Operator’s Manual 3-5

Chapter 3

Electromagnetic Emissions and Immunity Declarations

Memory Card

Ty p e C o m pa c t F l a s h

Card International Association (PCMCIA) adapter

with Personal Computer Memory

Heater

Weighing System

Syringe Pump

Reservoir Level Detection System (optional)

Type Capacitive

Reservoir Wall Thickness 1-3.5 mm (wall thickness for hard shell reservoir)

Number of Sensors 2

AutoClamp System (optional)

Ty p e P n e um a t i c

Clamp Force 14.5 Kg (32 lbs)

Tubing 9.5 mm (3/8 in) ID x 2.4 mm (3/32 in) PVC

Air Pressure Required 379 - 689 kPa (55 - 100psi)

Not yet implemented.

Electromagnetic Emissions and Immunity Declarations

Emissions Declaration

The Performer CPB equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the Performer CPB equipment should ensure that it is used in such an environment.

Emission test Compliance Electromagnetic environment-guidance

RF Emissions CISPR 11

Harmonic emissions IEC 61000-3-2

Voltage fluctuation / flicker emissions IEC 61000-3-3

Immunity Declaration

The Performer CPB equipment is intended for use in the electromagnetic environment specified in the following tables. The customer or the user of the Performer CPB equipment should ensure that it is used in such an environment.

Tabl e 3-1 . Electromagnetic Emissions for all Equipment and Systems

Group 1 The Performer CPB equipment generates

Class A

Class A The Performer CPB equipment is suitable

Complies

(Reference EN60601-1-2)

radio frequency (RF) energy only as a byproduct of its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

3-6 Operator’s Manual

Technical Specifications

Electromagnetic Emissions and Immunity Declarations

Tabl e 3-2. Electromagnetic Immunity for all Equipment and Systems

(Reference EN60601-1-2)

Immunity test IEC 60601 Test level Compliance level Electromagnetic

environment-guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

Electrical fast transient/ burst (ESD) IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruption, and voltage variations on power supply input lines

IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field

IEC 61000-4-8

±6 kV contact ±8 kV in air

±2 kV for power supply lines

Complies to the test level

Complies to the test

level ±1 kV for input/output lines

±1 kV differential mode ±2 kV common mode

<5% U

(>95% dip in UT)

Complies to the test

level

Complies to the test

level for 0.5 cycle

40% U

(60% dip in UT) for 5 cycle

70% U

(30% dip in UT) for 25 cycle

<5% U

(>95% dip in UT) for 5 sec

3 A/m Complies to the test

level

Floor should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity must be at least 30%.

Main power quality must be that of a typical commercial or hospital environment.

Note: In consideration of the possibility of continuous functional operation during main power interruption, the Performer CPB equipment is provided with an Uninterruptible Power Supply (UPS) with battery.

Power frequency (50/60 Hz) magnetic field must be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note: U

is the AC main voltage prior to application of the test level.

Operator’s Manual 3-7

Chapter 3

Electromagnetic Emissions and Immunity Declarations

Tabl e 3-3. Electromagnetic Immunity for Life Supporting Equipment and Systems

(Reference EN60601-1-2)

Immunity test IEC 60601 Test level Compliance

level

Electromagnetic environment-guidance

Follow the recommended separation distance calculated from the equation applicable to the frequency of the transmitter when using portable and mobile RF communication equipment in close proximity to any part of the Performer CPB equipment, including cables.

Recommended separation distance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz Outside ISM bands

10 Vrms 150 kHz to 80 MHz in ISM bands

10 V/m 80 MHz to 2.5 GHz

3Vrms d= 1,2√ P

6Vrms d= 2√ P

10 V/m

d= 1.2√ P 80 MHz to 800 MHz

d= 2.3

√ P 800 MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m)

Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveyc, should be less than the compliance level in each frequency range

Interference may occur in the vicinity of equipment marked with the following symbol:

3-8 Operator’s Manual

1. At 80 MHz and 800 MHz, the higher frequency range applies.

2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

The ISM (Industrial, Scientific and Medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283; and 40.66 MHz to 40.70 MHz.

The compliance levels in the ISM frequency bands 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communication equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges.

Technical Specifications

Electromagnetic Emissions and Immunity Declarations

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones, land mobile radios, amateur radios, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Performer CPB equipment is used exceeds the applicable RF compliance level above, the Performer CPB equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Performer CPB equipment.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and Performer CPB Equipment

The Performer CPB equipment is intended for use in an electromagnetic environment in which radiated RF disturbance is controlled. The customer or user of the Performer CPB equipment can help prevent electromagnetic interference by distancing the portable and mobile RF communication equipment (transmitters) as far away as possible from the Performer CPB as recommended in Table 3-4, according to the maximum output power of the communication equipment.

Tabl e 3-4 . Recommended separation distance between portable and mobile RF

communication equipment and the Equipment or System for Life-Supporting Equipment and

Rated maximum output power of

transmitter

150 kHz to 80 MHz outside ISM bands

d= 1.2

Systems (Reference EN60601-1-2)

Separation distance according to frequency of transmitter

√ P

150 kHz to 80 MHz in ISM bands

d= 2√ P

80 MHz to 800 MHz

d= 1.2√ P

800 MHz to 2.5 GHz

d= 2.3√ P

0.01 0.12 0.20 0.12 0.23

0.1 0.380.630.380.73

11.221.22.3

10 3.8 6.3 3.8 7.3

100 12 20 12 23

For transmitters rated at the maximum output power not listed above, the recommended separation distance d in meters (m) can be determined by using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watt (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note 2: The ISM (Industrial, Scientific and Medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283; and 40.66 MHz to 40.70 MHz.

Note 3: An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communication equipment could cause interference if it is inadvertently brought into patient areas.

Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by adsorption and reflection from structures, objects, and people.

Operator’s Manual 3-9

Chapter 3

Monitoring System for Hematocrit, Temperature and O

Saturation

Monitoring System for Hematocrit, Temperature and O2 Saturation

The Performer CPB equipment has an integrated device, called the Hematocrit-Temperature-Saturation (HTS) Module, that allows the user to measure:

■

blood oxygen saturation in blood (Sat O2)

■

red blood cell concentration (hematocrit) in blood (Hct)

■

temperature of 8 external locations, detected by as many thermistor probes, connected with the device by means of a standard “jack” connection

O2 Sat/Hct

Caution: The oxygen saturation and hematocrit monitoring system is not intended to substitute for regular patient observation and laboratory testing. Prior to any therapeutic treatment, the oxygen saturation and hematocrit should be determined by laboratory methods.

Warning: Do not connect the external temperature probes in conjunction with electrocautery.

Warning: The device must be used only with thermistor temperature probes, as indicated by the manufacturer.

Warning: The device has been designed in conformity with the IEC 60601-1-2 norm. It is advisable, however, to avoid its use in the presence of electromagnetic fields or other equipment causing interference (eg, cellular phones).

Warning: In case of electromagnetic interferences, the temperature values detected by the external probes and indicated on the main display may undergo transitory variations. However, this is not an alarming condition for the patient since the temperature signals are not employed in the temperature control feedback. In the subsequent measurements, the user shall carefully evaluate the value(s) reliability in relation to the real conditions before proceeding with whatever action or control system modification.

Electrical Data

Voltage 5 V DC

Current 0.2 A

3-10 Operator’s Manual

Patient's leakage current < 0.001 mA

Performance

Sat O

operating range 40 to 99%

Sat O

accuracy ± 4% (with In-Vivo Offset, see page 5-92)

Hct operating range 15 to 50%

Hct accuracy ± 4% (with In-Vivo Offset, see page 5-92)

Temperature Range +2°C to +45°C

Temperature Accuracy ± 0.5°C

Temperature Probes

The manufacturer guarantees the proper functioning of the HTS device for the temperature measurement only when the following probe type is used (thermistor probe):

Type Model Re-usable / Disposable

YSI Series 400 Re-usable

Warning: The utilization of other manufacturers' probes may jeopardize the performance of the device and, as a consequence, the measurement reliability.

The performance and precision of the reusable probes indicated in the previous table will continue if the following recommendations are followed:

Technical Specifications

Temperature Probes

High Temperature

Life

Mechanic Stresses

Disinfection

Warning: A periodical maintenance/control of the multiple-use probes detecting

efficacy is recommended every 3 months.

Battery Supply System (UPS)

The Performer CPB is equipped with a battery Uninterruptible Power Supply (UPS) system that provides the low voltage supply (24V) if the main power supply fails, thus allowing treatment to continue.

Note: When the Uninterruptable Power Supply (UPS) converts the system to battery power, ALL pumps, pump functions, safety systems, alerts, alarms, monitors, controls, the Pinch Valve and the Central Information Display (CID) are active and function the same as when the system is on AC power.

■

Do not expose the probe to temperatures higher than 100°C.

■

Only expose the probes to temperatures in the range of 80°C and 100°C for short periods of time.

Prolong the life of the cable by frequently sprinkling it with talcum powder, especially after disinfection.

Ensure that the cable is not subject to excessive mechanical stress like traction, squeezing, or kinking.

For proper disinfection of the multiple-use probes, refer to the instructions supplied by the manufacturer inside the packaging.

In case of a main supply failure, fully-charged battery backup will allow treatment with a fully loaded system to continue for a minimum of 30 minutes (see page 5-44.)

Operator’s Manual 3-11

Chapter 3

IEC 60601-2-16 Compliance Chart

Recharging of the battery pack is performed by means of a special circuit located in the base, therefore allowing the battery pack to get completely recharged when the equipment is turned on and is operated by the main power supply.

It takes approximately 6 hours to completely recharge a fully depleted battery pack.

IEC 60601-2-16 Compliance Chart

REQUIREMENT REFERENCE RESULT-REMARK

1. Description of the Installation Procedure

2. Syringe Pump Specification N/A; this device is not

3. Blood Pump accuracy and specification; range, pressure accuracy

4. Protective system description of the dialysis fluid composition

5. Protective system description of the dialysis fluid temperature

6. Protective system description of the ultra-filtration

7. Protective system description of the extracorporeal blood loss to the environment

8. Protective system description of the blood leak

(51.101) N/A; there is no dialysis fluid

(51.102) N/A; there is no dialysis fluid

(51.103) N/A; there is no ultra-filtration

(51.104.1) N/A; the perfusionist is

(51.104.2) N/A; the perfusionist is

See IFU page 4-2.

implemented at this time.

See IFU page 3-3 to page 3-4.

processing with this device.

processing system with this device.

continually in view of the device during use.

3-12 Operator’s Manual

9. Protective system description of the blood loss due to the coagulation

(51.104.3) See IFU page 5-90. If the

circulating hematocrit falls below 20%, the Protective System activates distinct audible and visual cues to warn the user. In case the blood pump stops during Perfusion Mode or in case the blood pump is stopped inadvertently, after 60 seconds the Protective System activates distinct audible and visual alarms.

Technical Specifications

IEC 60601-2-16 Compliance Chart

10. Protective system description of the Arterial Pressure

11. Protective system description and sensitivity of the Air Infusion prevention

12. Protective system description of the Buffer-free HDF

13. Over-ride time of the Protective System

(51.105) See IFU page 5-84. When the

arterial pressure alert limit is exceeded, the Protective System activates distinct audible and visual cues to warn the user. When the arterial pressure alarm limit is exceeded, the Protective System activates distinct audible and visual cues to warn the user and immediately stops the blood pump.

(51.106) For the system description, see

IFU page 5-63. For the system sensitivity, see IFU page page 3-4. When air is detected by an Air Bubble Detector (ABD), the Protective System activates distinct audible and visual alarm cues to warn the user and immediately stops the blood pump.

(51.111) N/A; there is no Buffer-free HDF

preparation with this device.

(51.108) See IFU page 7-2. An over-ride

of the Protective System will activate continuous visual and audible “alert” cues.

See IFU page 5-66. The audible alarm cue can be temporarily muted. If the Protective System is not corrected and reset within one minute, the audible alarm cue will automatically resume.

14. Audible alarm time period (51.107) See IFU page 5-66. The audible

15. Sound pressure level of audible alarm source.

16. Contact material with dialysis fluid

(51.107) See IFU page 5-30. Except for

(51.107) N/A; there is no dialysis fluid

alarm cue can be temporarily muted. If the Protective System is not corrected and reset within one minute, the audible alarm cue will automatically resume.

the VARD Alarm, the sound level (volume) for alarms is not settable.

processing with this device.

Operator’s Manual 3-13

Chapter 3

IEC 60601-2-16 Compliance Chart

3-14 Operator’s Manual

Installation 4-2

Installation Checklist and Commissioning 4-3

Installation

Operator’s Manual 4-1

Chapter 4

Installation

All installation and verification procedures shall be performed in the presence of authorized, service personnel.

Installation

■

After unpacking the equipment, verify its integrity and the presence of the necessary accessories.

■

Do not install the equipment near areas at risk of explosion or where flammable anaesthetic gases are used.

■

Do not turn on the equipment if any physical anomalies are noticed that could jeopardize the correct functioning of the equipment. Contact a Medtronic service technician.

■

Do not use adapters or extension cords on the main power cable. If necessary, replace the equipment plug with one that is consistent with the available power supply system.

Grounding

■

Since the Performer CPB is a Class I device per IEC 60601-1 (Clause 14), it must be connected to a properly grounded power source.

■

The grounding reliability of the power source must be accomplished in accordance with the effective local regulation and the IEC 60601-1 harmonized standard (Clauses 18, 58: Protective earthing, functional earthing and potential equalization).

■

The hospital/clinic’s electrical environment department should be contacted for any clarification or questions.

Potential Equalization Line

If other pieces of equipment are present, the use of the specific connection for the potential equalization is recommended.

Power Supply

The equipment must be operated from the type of power indicated on the identification data label.

■

Vol ta ge AC 100/240

■

Frequency 50/60 Hz

Liquid/Foreign Matter Penetration

The equipment is protected from liquid/foreign matter penetration according to the IEC 60529 standard definition: protection class of the Performer CPB is IP 21.

Turn in g O n

Operate the equipment only when it has reached room temperature.

Intended use

The Performer CPB equipment is intended exclusively for hospital use.

The Performer CPB equipment is NOT for domestic use.

4-2 Operator’s Manual

Installation Checklist and Commissioning

VISUAL INSPECTION

 Integrity of external components; check for damages due to transport

 Identification data label, stickers, warning labels

 Main Power Supply voltage, plug model, cable and fair-leads

 Movement of rotating parts

 Accessories and documentation

FUNCTIONAL INSPECTION

 Height regulation device

 Braking device

 Central Information Display

■

Configuration Mode

■

Touch Screen alignment

■

Perfusion Mode

Installation

Installation Checklist and Commissioning

 Bio-Pump Control Panel and Display

 Roller Pump Control Panels and Displays

 Pressure Sensors

■

PR1, PR2, PR3, PR4, VLP, ALP, PR7, PR8

■

Test Measurement at 0 mm Hg

■

Test Measurement at +450 mm Hg

■

Test Measurement at -450 mm Hg

 HTS Module

■

Temperature

■

O2 Sat / Hematocrit

 Bio-Pump

 Flow Probe / Air Bubble Detector

 VARD Ultrasonic Sensors

 Cardioplegia Air Bubble Detector

 FIL Sensor

 Roller Pumps

 AAR Solenoid Pinch-Valve

 Printer

 Battery Pack charge level and UPS

 AutoClamp System (optional)

 Reservoir Level Detection System (optional)

 System Mode Simulation

Operator’s Manual 4-3

Chapter 4

Installation Checklist and Commissioning

ELECTRICAL SAFETY CHECK PER IEC EN 60601-1 REGULATIONS

 Protective earth resistance

 Earth leakage current NC

 Housing leakage current NC

 Leakage current with main voltage on A.P.

 Patient leakage current (A.P.) NC

4-4 Operator’s Manual

Instructions for Use

Console 5-2

Roller Pump, Roller Inserts, Tube Inserts, and Tubing 5-6

System Configuration 5-16

System Start-up 5-35

Main Run Screen 5-41

Timers 5-46

Cardioplegia 5-49

AAR Controller - Venous Air Removal Device (Resting Heart mode only) 5-58

Air Detection 5-63

Level Sensing System (Bio-Pump CPB mode only) 5-67

AutoClamp System (Bio-Pump CPB mode only) 5-73

Pressure Mode Selection 5-84

Venous Saturation and Hematocrit Monitoring 5-90

Options Menu Screen 5-94

Servo (Resting Heart mode only) 5-104

Preparing for Cardiopulmonary Bypass Checklist 5-109

Initiating Extracorporeal Support Checklist 5-112

Operator’s Manual 5-1

Chapter 5

Console

External Operational Controls

Figure 5-1. Performer CPB Controls

1. Power Cord: Connects the system to the appropriate wall electrical (AC) power supply.

2. Fuse/Circuit Breakers: For service personnel use only. The replacement of a malfunctioning external fuse(s) must be performed by using the correct fuse(s) type indicated by the external label and by the manufacturer (see “General Data” on page page 3-2).

3. Grounding Equalization Post: When local regulations require “potential compensation,” connect a cable from the potential compensation network to this grounding equalization post.

4. Main Power Switch: Press the top of the Main Power switch to turn the system on. The displays next to the pump controls will illuminate and an audible start-up tone will sound. To turn off AC power, press the bottom of the Main Power switch.

5. Console Up and Down Switches: Press and release the Up switch to elevate the console on its pedestal to the maximum “up” limit. Press and release the Down switch to lower the console on its pedestal to the maximum “down” limit. The user may stop console up or down movement at any time by pressing and releasing the respective Up or Down switch once the desired height is reached.

Note: The press-and-release function of the console Up/Down switches are disabled after leaving the Home Screen and entering an operational mode (Resting Heart or Bio-Pump CPB). To adjust the height while in an operational mode, the user must press and hold the respective Up or Down switch until the desired height is reached.

5-2 Operator’s Manual

6. Castor Brake and Unbrake Switches: The console is mounted on 4 castors. The two rear castors are in permanent front-to-back alignment, but the two front castors swivel 360 degrees. Press the Castor Brake switch to prevent the console from rolling. Press the Castor Unbrake switch to release the brakes and enable movement of the console.

7. Batteries: Integrated batteries provide uninterruptible battery backup for the entire system in the event wall power is lost. Fully-charged batteries will power the system for a minimum of 30 minutes with a fully loaded system (see page 5-44).

Front Panel - Controls and Displays

Instructions for Use

Console

Figure 5-2. Console Front Panel

1. CID (Closed): Incorporates graphic menus and buttons for the user-selectable options, provides enabling or disabling of components and safety devices, provides visual and audible signals during alert and alarm conditions, monitors system functions during use, and displays information pertinent to patient physiology during extracorporeal procedures.

2. Bio-Pump Control Panel with Backup Displays: Incorporates a pump speed RPM knob, LED flow display, and two backup LCD displays. (See Figure 5-4.)

3. Roller Pump Control Panel and Display for PM1: Incorporates a Start/Stop button to enable/disable the pump motor, a 3-turn potentiometer knob to control RPM, an LCD to indicate motor on/off status, pump flow, or RPM information, and pump identification information.

4. Large Roller Pump PM1: Configured for suction or left heart venting. Maximum flow capacity is 3.7 L/min. Accommodates the following tube sizes:

■

6.4 mm (1/4 in) x 1.2 mm (1/16 in)

■

6.4 mm (1/4 in) x 1.2 mm (1/16 in) and 6.4 mm (1/4 in) x 1.2 mm (1/16 in) (Two tubes)

■

9.5 mm (3/8 in) x 2.4 mm (3/32 in) (PVC)

5. External Communication Interface: RS-485/USB port to connect the Performer CPB to a perfusion data collection system.

Operator’s Manual 5-3

Chapter 5

Console

6. Small Roller Pump PM4: Configured for delivery of cardioplegia. Maximum flow capacity is 1.1 L/min. Accommodates the following tube sizes:

■

6.4 mm (1/4 in) x 1.2 mm (1/16 in) and 6.4 mm (1/4 in) x 1.2 mm (1/16 in) (Two tubes)

■

6.4 mm (1/4 in) x 1.2 mm (1/16 in) and 3.2 mm (1/8 in) x 1.2 mm (1/16 in) (4:1 Cardioplegia)

■

6.4 mm (1/4 in) x 1.2 mm (1/16 in)

7. Roller Pump Control and Display for PM4: Incorporates a Start/Stop button to enable/disable the pump motor, a 3-turn potentiometer knob to control RPM, an LCD display to indicate motor on/off status, pump flow, or RPM information, and pump identification information.

8. Small Roller Pump PM3: Configured to be used either as a cardioplegia slave pump in conjunction with PM4, or as a free pump (examples: hemoconcentrator, aortic root vent). Maximum flow capacity is 0.6 L/min. Accommodates the following tube sizes:

■

6.4 mm (1/4 in) x 1.2 mm (1/16 in)

■

3.2 mm (1/8 in) x 1.2 mm (1/16 in)

9. Roller Pump Control and Display for PM3: Incorporates a Start/Stop button to enable/disable the pump motor, a 3-turn potentiometer knob to control RPM, an LCD to indicate motor on/off status, pump flow, or RPM information, and pump identification information.

10. Large Roller Pump PM2: Configured for suction or left heart venting. Maximum flow capacity is 1.5 L/min. Accommodates the following tube sizes:

■

6.4 mm (1/4 in) x 1.2 mm (1/16 in)

■

6.4 mm (1/4 in) x 1.2 mm (1/16 in) and 6.4 mm (1/4 in) x 1.2 mm (1/16 in) (Two tubes)

■

9.5 mm (3/8 in) x 2.4 mm (3/32 in) (PVC)

11. Roller Pump Control and Display for PM2: Incorporates a Start/Stop button to enable/disable the pump motor, a 3-turn potentiometer knob to control RPM, an LCD to indicate motor on/off status, pump flow, or RPM information, and pump identification information.

12. PR1 Pressure Transducer Port: Connects to a pressure monitoring line with fluid isolator when pressure-limiting safety responses are required with roller pump PM1.

System Status LEDs (Green, Yellow, and Red)

At the top of the CID, but outside the touch screen, are three colored lights that are associated with the operation status of the system. These lights serve as an additional visual cue for the user when a change in an alarm, alert, or system status occurs.

Figure 5-3. System Status LEDs

5-4 Operator’s Manual

1. When the green lights are illuminated, all safety devices are engaged and all systems are functioning normally.

2. When the yellow lights are illuminated, there is either a system status change, a safety device is not engaged, or the Alert Mode of a safety device is activated.

3. When the red lights are illuminated, the Alarm Mode of a safety device is activated.

Bio-Pump Control Panel

Instructions for Use

Console

Figure 5-4. Bio-Pump Control Panel

1. Pump Speed RPM Knob

■

Turn the knob clockwise to control the external drive motor speed from 0 to approximately 4500 RPM.

■

Completely rotate the knob counterclockwise to below 0 RPM and “click” to turn the drive motor off.

■

The knob provides for a minimum RPM detent button. This is a mechanical stop that prevents an unintentional reduction of RPM below 2000. Press down on the detent lever while turning the knob counterclockwise to reduce the RPM below 2000.

■

The minimum RPM detent button does not affect increasing the RPM.

2. Flow Display

■

Displays the Bio-Pump flow rate in liters per minute (L/min). This is an additional display for the Bio-Pump flow value that is also shown on the Main Run Screen of the CID.

■

The LED will display flow from 0.00 to 9.99 L/min.

Note: In the event the CID fails, the front panel Bio-Pump flow display will continue to function and display blood flow detected by the ultrasonic blood flow transducer.

3. Backup LCDs

■

Two LCDs display 6 user-selected hemodynamic or metabolic parameters.

■

The LCDs provide additional displays of essential parameters viewed on the CID.

Note: In the event the CID fails, the LCDs will continue to function and enable selection and display of the listed parameters. (See “Emergency Procedures” on page 7-4.)

4. Scroll Arrows

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Roller Pump, Roller Inserts, Tube Inserts, and Tubing

The scroll arrows allow selection/viewing of the following parameters in each of the backup LCDs (only in the Emergency Mode):

■

Revolutions Per Minute (RPM)

■

Arterial Line Pressure (ALP)

■

Venous Line Pressure (VLP) (Resting Heart mode only)

■

Cardioplegia Pressure (CPG)

■

Venous Oxygen Saturation (SO2)

■

Hematocrit (Hct)

Roller Pump, Roller Inserts, Tube Inserts, and Tubing

Roller Pumps

Roller pumps are indicated for moving fluids through a flexible tube. As each roller passes through the pump raceway, it occludes the tube and displaces the fluid in the tube in the direction of rotation.

Each pump only rotates in a clockwise direction.

Uses include, but are not limited to, propulsion of arterial blood and myocardial preservation solutions, and extraction of fluids from the thorax or vascular chambers.

The Performer CPB comes with two (2) large roller pumps with a maximum flow potential of 3.7 L/min (PM1) or 1.5 L/min (PM2) and two (2) small roller pumps with a maximum flow capacity of 1.1 L/min (PM4) or 0.64 L/min (PM3).

3 5 6

Figure 5-5. Roller Pump Components

1. 3-Turn Roller Speed Control Knob

2. Start/Stop Button

3. Pump Label and Units of Measure for the Digital Display for flow or RPM

4. Digital Display for flow or RPM

5. Calibrated Roller Insert

6. Pump Safety Cover

7. Pump Safety Cover Interlock Sensor

8. Pump Raceway

5-6 Operator’s Manual

Roller Insert

Instructions for Use

Roller Pump, Roller Inserts, Tube Inserts, and Tubing

Figure 5-6. The Calibrated Roller Insert

1. Integrated Handcrank

2. Closed Handcrank Locking Channel

3. Tubing Guides

Installing the Roller Insert

To install the roller insert:

1. Place the pump in the Stop Mode and lift the pump safety cover.

2. Unlatch and lift the integrated handcrank on the roller insert.

3. Slide the roller insert over the motor drive shaft so the alignment pin in the center of the roller insert matches the groove in the motor drive shaft.

4. Rotate the roller insert until the close/locking channel for the integrated handcrank aligns with the channel in the end of the motor drive shaft.

5. Latch the integrated handcrank into the close/locking channel.

6. Close the pump safety cover.

Removing the Roller Insert

1. Place the pump in the Stop Mode and lift the pump safety cover.

2. Ensure the tubing is removed from the pump.

3. Unlatch and lift the integrated handcrank on the roller insert.

4. Slowly rotate the roller insert while applying slight outward traction until the alignment pin “finds” the groove in the motor drive shaft.

5. Slide the roller insert out to remove.

Setting the Roller Pump Speed

1. A flashing digital display indicates the pump Start/Stop button is in the Stop Mode. Turn the roller speed control knob completely counterclockwise. Ensure that the digital display is flashing “0.”

2. Press the Start/Stop button to activate the pump. The digital display will stop flashing.

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Roller Pump, Roller Inserts, Tube Inserts, and Tubing

3. Turn the roller speed control knob to set the pump speed. Clockwise rotation increases RPM; counterclockwise rotation decreases RPM. The full turning range of each control knob is three turns.

4. As the pump speed changes, the digital display will reflect the parameter of either the pump RPM or the flow rate in milliliters per minute (mL/min) or liters per minute (L/min), indicated on the pump label.

5. To stop the pump, press the Start/Stop button. The digital display will flash.

6. After the pump is stopped, ensure that the roller speed control knob is rotated completely counterclockwise and the digital display is flashing “0.”

7. To change the pump label, refer to the “System Configuration” section on page 5-16.

Manual Operation with the Integrated Handcrank

Warning: If handcrank operation is necessary due to the loss of AC and battery

power, flow detection and safety systems are inoperable. Closely monitor the circuit to prevent introduction of air.

Note: The rollers in the roller inserts are installed with one-way bearings to prevent inadvertent reverse handcranking. When tubing in installed in the pump raceway, the rotation of the pump will only occur in a clockwise direction.

1. Ensure that the pump is in the Stop Mode and lift the pump safety cover.

2. Unlatch the integrated handcrank.

5-8 Operator’s Manual

3. Slide the handcrank extension over the small black knob.

4. Grasp the large black knob on the handcrank extension and rotate the pump clockwise.

Tube Inserts

Instructions for Use

Roller Pump, Roller Inserts, Tube Inserts, and Tubing

Installing the Tube Inserts

To install the tube inserts:

1. Place the pump in the Stop Mode and lift the pump safety cover.

2. Remove the faceplate thumbscrew.

3. Slide the faceplate outward along the dovetail joint and remove.

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Roller Pump, Roller Inserts, Tube Inserts, and Tubing

4. Place the appropriate size tube insert into the slide channel. Note the location of the hinge.

5. Replace the front faceplate to the pump housing and slide inward along the dovetail joint.

5-10 Operator’s Manual

6. Replace the faceplate thumbscrew and close the cover.

Tubing

Instructions for Use

Roller Pump, Roller Inserts, Tube Inserts, and Tubing

Loading the Tubing

To load the tubing:

1. Place the pump in the Stop Mode. Ensure that the appropriate roller insert for the tubing size being used is properly installed. Ensure the appropriate tube inserts are installed for the tubing size(s) being used.

Warning: Always ensure proper direction of rotation before installing tubing into the roller pump and that the direction of forward flow for the tubing is consistent with the rotational direction of the roller pump. Always ensure that the direction of flow is NOT in a retrograde direction that would result in pumping air into the patient.

2. Lift and open the tube inserts.

3. Open the cover and unlatch the handcrank. Rotate the roller insert clockwise to optimize space in the pump raceway to accommodate the tubing.

4. Align the tubing along the arc of the pump raceway while placing the tubing into the tube inserts.

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Roller Pump, Roller Inserts, Tube Inserts, and Tubing

5. Close and then press the inlet tube insert into its channel guide.

6. Feed the tubing between the guide rollers and along the arc of the pump raceway while rotating the roller insert by hand.

7. Close and press the outlet tube insert into its channel guide. Ensure that the tubing is held securely in the tube inserts by pulling it lightly. Inspect the tubing in the pump raceway so it is not twisted and fits evenly.

5-12 Operator’s Manual

8. Latch the handcrank into the locking channel of the motor drive shaft.

Instructions for Use

Roller Pump, Roller Inserts, Tube Inserts, and Tubing

9. Close the pump safety cover.

Loading the Tubing (Mechanical Loading Feature)

1. Lift the roller cover and slide out the tube inserts.

2. Open the tube inserts.

3. Lay the tubing along the circumference of the pump housing to estimate the length of the tubing to place in the pump raceway.

4. Secure the tubing into the tube insert at the pump inlet. Close the insert and press into the channel guide.

5. Secure the tubing in the tube insert at the pump outlet. Close the insert, but do not press into the channel guide.

6. Close the pump safety cover as much as it will allow.

7. Press in the Options Menu Screen.

8. Press in the Roller Pump Configuration Screen until the red indicator on the console graphic corresponds with the roller pump that is being loaded with tubing.

9. Press the gray Tube Loading button . When it changes color, press and hold the roller pump Start/Stop button. The roller pump will slowly turn and load the tubing into the pump raceway. When the tubing is loaded, release the pump Start/Stop button to stop the roller pump from turning.

Note: The Tube Loading button will only stay active for 10 seconds each time it is pressed. The top line of the message bar will display “LOADING/UNLOADING PM1 PUMP SEGMENT.”

10. Press the tube insert at the pump outlet into the channel guide.

11. Ensure the pump safety cover is closed.

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Roller Pump, Roller Inserts, Tube Inserts, and Tubing

Connections for Peripheral Components

Figure 5-7. Peripheral Connections

1. AAR FIL Sensor: Detects the presence of air or fluid when used in conjunction with the VARD purge line. [Resting Heart mode only]

2. PR2 Pressure Transducer Port: Connects to a pressure monitoring line with a fluid isolator when pressure-limiting safety responses are required with roller pump PM2.

3. For the Bio-Pump CPB mode, this port is designated the PR7 Pressure Transducer Port. It connects to a pressure line with fluid isolator and enables the use of optional pressure-limiting safety responses. For the Resting Heart mode, this port is the AAR Vacuum Pressure Sensor. It connects to the vacuum pressure line with a fluid filter on the VARD suction tube.

4. Cardioplegia Air Sensor: Detects macro-air in the 6.4 mm (1/4 in) x 1.2 mm (1/16 in) line between the cardioplegia pump (PM4) and the cardioplegia heat exchanger and air bubble trap.

5. PR3 Pressure Transducer Port: Connects to a pressure monitoring line with a fluid isolator when pressure-limiting safety responses are required with roller pump PM3.

6. For the Bio-Pump CPB mode, this port is designated the PR5 Pressure Transducer Port. It connects to a pressure line with fluid isolator and enables the use of optional pressure-limiting safety responses. For the Resting Heart mode, this port is labeled the Venous Line Pressure (VLP) Sensor. It is used to monitor the Venous Line Pressure and enables configuring Bio-Pump responses if conditions occur that exceed user-defined negative pressure limits.

7. Arterial Line Pressure (ALP) Sensor (PR6): Connects to a pressure monitoring line with a fluid isolator from the arterial circuit when Bio-Pump responses are required if conditions occur that exceed user-defined positive pressure safety limits.

8. PR4 Pressure Transducer Port: Connects to a pressure monitoring line with a fluid isolator when pressure-limiting safety responses are required with the cardioplegia roller pump (PM4).

9. Multi-purpose Mounting Flange(s): Attaches to pole supports for mounting hardware and brackets.

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Instructions for Use

Roller Pump, Roller Inserts, Tube Inserts, and Tubing

10. AAR Pinch Valve: Opens and closes on the suction tube between the VARD and a rigid suction canister. [Resting Heart mode only]

11. External Devices Connector Panel: Connection site for external devices.

Figure 5-8. External Devices Connector Panel

1. Connection site for the ultrasonic flow sensor with Air Bubble Detector.

2. Connection site for the Bio-Pump External Drive Motor. Warning: Only use a Bio-Pump External Drive Motor with a cable that does not exceed 120 cm in length.

3. Connection site for the VARD cable.

4. Connection site for the Level Sensor Cable.

5. Connection site for the AutoClamp System Interface Cable.

CompactFlash® Memory Card with PCMCIA Adapter Installation

The CompactFlash® memory card is used to perform software upgrades with the Performer CPB and to store perfusion data following a case.

Note: Use only Medtronic approved CompactFlash

The slot to install the CompactFlash

memory card is next to the printer.

memory cards.

Note: Before installing the card and adapter into the Performer CPB, ensure the system power is off.

1. To insert the CompactFlash

CompactFlash

memory card so that the slot/groove on the edge of the card

memory card into the PCMCIA adapter, orient the

aligns with the slot/groove on the PCMCIA adapter.

2. Slide the card fully into place until the pin protector is fully depressed and the card “clicks” into place.

3. Open the printer access panel.

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System Configuration

4. Orient the label side of the CompactFlash® memory card towards the front of the console.

5. Depress the PCMCIA adapter fully into the slot. The release button next to the card will protrude upward when the adapter is fully seated in the slot.

6. To remove the PCMCIA adapter, depress the release button.

Note: To download data, the CID must be in the Home Screen.

Warning: After the CID is changed to the Home Screen, the screen will display an

hourglass icon for approximately 10 seconds, indicating data download to the CompactFlash data download. DO NOT remove the PCMCIA adapter until the hourglass has cleared and the red LED goes off.

System Configuration

System Configuration is a user-defined programming process that is necessary to ensure that the safety systems and pump functions of the Performer CPB conform to the conduct of perfusion protocols specific to how either the Resting Heart mode and the Bio-Pump CPB mode will be used at the institution. It is typically a one-time setup procedure performed by a Perfusionist designated as the System Administrator. It is recommended this process be completed before the Performer CPB is used for a surgical bypass procedure.

Each Performer CPB comes pre-programmed with factory default settings for the Resting Heart mode and Bio-Pump CPB mode. When these settings are modified by the System Administrator during the process of System Configuration, these new settings can be saved as a new profile and can be password protected by the System Administrator (see “Password Protection” on page 5-18).

memory card. The red LED next to the PCMCIA slot also indicates

Preparation for Use

To begin using the Performer CPB, plug the console into an appropriate AC power outlet, lift the CID, and turn on the Main Power switch. The CID will display “SYSTEM INITIALIZATION” for several seconds, followed by the Power On Self-Test (POST) screen (see Figure 5-9).

5-16 Operator’s Manual

Instructions for Use

System Configuration

Power On Self-Test

Figure 5-9. Power On Self-Test Screen

Warning: Ensure the roller pump safety covers remain closed during the POST.

Warning: Ensure that all pressure transducer ports are open to atmosphere during

the POST.

Warning: When running the Resting Heart mode, ensure there is no tubing in the pinch valve for the AAR Controller.

During the POST, the system will cycle through the following four test procedures:

■

Pressure Calibration: Confirms that the pressure transducer channels zero properly.

■

Relay 24: Confirms the proper operation of the 24-volt relay.

■

Roller Pumps: Confirms the proper operation of the four roller pumps. During this test, the roller pumps will rotate for several seconds and then automatically stop.

■

VARD Pinch Valve: Confirms the pinch valve opens and closes properly. (Resting Heart mode only)

Following each test cycle, the POST screen will indicate whether the system PASSED (green checkmark) or FAILED (red X) the test. If all tests have PASSED, the screen will automatically proceed to the Home Screen.

If any test fails:

■

a red X will indicate the affected system

■

three alarm tones will sound

■

the system status LED will change to red

■

the message bar will change to red

■

the message bar will display “SELF-TEST FAILED”

To repeat the POST due to a FAILED test, press the Repeat Self-Test button in the upper-right corner of the screen . When the Repeat Self-Test button is pressed, the following will occur:

■

the system status LED changes to yellow

■

the message bar changes to blue

■

the message bar reads “POWER ON SELF-TEST RUNNING”

Warning: If the POST repeatedly produces a FAILED indication, contact a Medtronic service representative.

To skip the POST, press in the upper-right corner of the CID.

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System Configuration

Warning: Bypassing the POST at any time may cause error messages or malfunction during use.

A window will appear asking, “Do you really want to skip power on self-tests?”

Press the green checkmark to bypass the POST and proceed to the Home Screen.

PASSED Self-Test When all the self-test functions indicate PASSED, the CID will automatically proceed to the Home Screen.

Password Protection

2 3

1. Ensure the Home Screen displays the proper Perfusion Mode (Resting Heart or Bio-Pump CPB).

2. Press “SYSTEM CONFIGURATION” to enter the Configuration Mode. A five-digit password must be entered to begin use of the Configuration Mode.

3. As the password numbers are entered using the numeric buttons, the system will place an asterisk in the box and the cursor will automatically advance to the next box. Once the correct password is entered, the screen will automatically revert to the User Profiles screen of the Configuration Mode.

4. Press to revert back to the Home Screen.

Note: To configure a new system administrator password, See “Password Configuration” on page 5-31.

Configuration Mode Screens

Access to the numerous Configuration Mode screens is achieved through the Menu Bar.

Figure 5-10. Configuration Mode Password Protection

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Instructions for Use

System Configuration

Menu Bar

Figure 5-11. Configuration Mode Screen Functional Areas

1. Menu Bar

2. Alpha-Numeric Keyboard

3. Display Area (Corresponds to what was selected in the Menu Bar.)

4. Components List with Scroll Arrows

5. Press to display special and language-specific characters in the numeric row of the keyboard.

The menu bar includes static function buttons used to select the components or systems for configuration. When a button is pressed, the functional category will appear in the configuration list area and configuration buttons will appear in the display area.

1 2 3 4 5 6 7 8

Figure 5-12. Menu Bar Options

1. Return to the Home Screen

2. User Profiles Configuration

3. Roller Pumps Configuration

4. Pressure Transducers Configuration

5. Temperature Channels Configuration

6. Safety Systems Configuration

7. User Preferences Configuration

8. Service Configuration

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System Configuration

Configuration of the Roller Pumps, Pressure Transducers, and Temperature Channels

Figure 5-13. Component Configurations

To configure the Roller Pumps:

1. Press on the menu bar.

2. Use the left/right scroll arrows to select the roller pump to be configured.

3. Press the lavender button under NAME.

4. Type the new name using the keyboard. As the letters are entered, the new name will appear in the highlighted button.

5. Save the new name by pressing the button with the new name.

■

Names for the roller pumps appear in their respective LCD display on the front of the console, on the Roller Pump Setup Screen, in the Safety Systems Configuration screens, and on the On-Bypass Parameters View Screen.

6. Press the lavender button under UNITS to select from the options of L/MIN, ML/MIN, or RPM.

7. Press the lavender button under TUBE to select from the options for the ID of the tube size(s) to be used (applicable only to roller pumps PM1 and PM2).

To configure the Pressure Transducers:

1. Press on the menu bar.

2. Use the left/right scroll arrows to select the pressure channel to be configured.

3. Press the lavender button under NAME.

4. Type the new name using the keyboard. As the letters are entered, the new name will appear in the highlighted button.

5. Save the new name by pressing the button with the new name.

■

Names for the pressure channels appear on the On-Bypass Parameters View Screen and in the blue Message Bar.

6. Press the lavender button under ALERT LIMIT or the ALARM LIMIT.

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7. Type the new pressure limit value using the keyboard. The system will accept either positive or negative values. Press the edited value in the button to save. If the new value is not saved, the window will revert back to the old value.

To configure the Temperature Channels:

1. Press on the menu bar.

2. Use the left/right scroll arrows to select the temperature channel to be configured.

3. Press the lavender button under NAME.

4. Type the new name using the keyboard. As the letters are entered, the new name will appear in the highlighted button.

5. Save the new name by pressing the button with the new name.

■

Names for the temperature channels appear on the On-Bypass Parameters View Screen and in the blue Message Bar.

Configuration of the Safety Systems

The Performer CPB comes pre-configured with factory default settings for pump responses to Safety System events. Review of these default settings is the responsibility of the System Administrator to ensure whether they conform to the conduct of the applicable perfusion protocols or whether settings need to be changed.

Instructions for Use

System Configuration

Tab le 5- 1. Default Pump Responses specific to Resting Heart Mode

EVENT BIO-PUMP PM-1 PM-2 PM-3 PM-4

Air in VARD MESSAGE

Too Mu ch A ir in VARD

Overpressure Alert: VLP

Overpressure Alarm: VLP

Overpressure Alert: VARD

Overpressure Alarm: VARD

ONLY

COAST NO

MESSAGE ONLY

COAST NO

MESSAGE ONLY

NO RESPONSE

RESPONSE

NO RESPONSE

RESPONSE

NO RESPONSE

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Tabl e 5-2 . Default Pump Responses specific to Bio-Pump CPB Mode

EVENT BIO-PUMP PM-1 PM-2 PM-3 PM-4

Low Blood Level Alert

Low Blood Level Alarm

Overpressure Alert: PR5

Overpressure Alarm: PR5

Overpressure Alert: PR7

Overpressure Alarm: PR7

Tabl e 5-3 . Default Pump Responses Common to both Resting Heart and Bio-Pump CPB

EVENT BIO-PUMP PM-1 PM-2 PM-3 PM-4

Air Detected by ABD

Air in Cardioplegia Circuit

COAST NO

STOP NO

MESSAGE NO

STOP STOP STOP STOP STOP

NO RESPONSE

RESPONSE

STOP STOP STOP STOP

NO RESPONSE

Modes

NO RESPONSE

Bio-Pump Stop

Bio-Pump Coast

Bio-Pump Backflow

Bio-Pump Low Flow

Bio-Pump High Flow

Overpressure Alert: ALP

Overpressure Alarm: ALP

Overpressure Alert: PR1

Overpressure Alarm:PR1

NO RESPONSE

MESSAGE ONLY

COAST NO

NO RESPONSE

STOP STOP STOP STOP

NO RESPONSE

RESPONSE

MESSAGE ONLY

PAU S E N O

NO RESPONSE

RESPONSE

NO RESPONSE

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Instructions for Use

System Configuration

EVENT BIO-PUMP PM-1 PM-2 PM-3 PM-4

Overpressure Alert: PR2

Overpressure Alarm: PR2

Overpressure Alert: PR3

Overpressure Alarm: PR3

Overpressure Alert: PR4

Overpressure Alarm: PR4

Overpressure Alert: PR8

Overpressure Alarm: PR8

Pump Cover Open: PM1

Pum

p Cover

Open: PM2

NO RESPONSE

MESSAGE ONLY

NO RESPONSE

PAU S E N O

NO RESPONSE

MESSAGE ONLY

PAU S E N O

NO RESPONSE

RESPONSE

PAU S E N O

NO RESPONSE

RESPONSE

MESSAGE ONLY

PAU S E N O

NO RESPONSE

RESPONSE

NO RESPONSE

RESPONSE

MESSAGE ONLY

PAUSE

NO RESPONSE

Pump Cover Open: PM3

Pump Cover Open: PM4

NO RESPONSE

PAU S E N O

NO RESPONSE

RESPONSE

PAU S E

Note: Editing Bio-Pump and roller pump responses is determined by the presence of a box in the columns labeled “Stop, Coast, Pause, Message Only, and No Response.” If no box is present, that response cannot be edited.

When operating in the Bio-Pump CPB mode, the Performer CPB comes pre-configured with factory default settings for the AutoClamp response to Safety System events. Reviewing these default settings is the responsibility of the System Administrator to ensure whether they conform to the conduct of the applicable perfusion protocols or whether settings need to be changed.

The configuration options for the AutoClamp are either CLOSE or NO RESPONSE.

Tabl e 5-4. Default AutoClamp Responses

The AutoClamp configuration options apply only to the following Safety System events:

BIO-PUMP STOP NO RESPONSE

BIO-PUMP COAST NO RESPONSE

Default System Configuration Settings

BIO-PUMP LOW FLOW NO RESPONSE

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System Configuration

BIO-PUMP BACKFLOW CLOSE

Note: All other Safety System events do not accommodate for user-defined configuration options for the AutoClamp The default setting is NO RESPONSE.

To assign pump responses to safety systems events:

1. Press the Safety Systems Configuration button to open the screen for assigning pump responses to safety system events.

Figure 5-14. Assign Pump Responses to Safety Systems Events

2. Assign the Bio-Pump response (Stop, Coast, Message Only, No Response) for the configurable event in the bar at the top of the screen

3. Assign the roller pump response (Stop, Pause, Message Only, No Response) for the configurable event in the bar at the top of the screen.

4. Assign the AutoClamp response (Close, No Response) for the configurable event in the bar at the top of the screen (Bio-Pump CPB mode only).

5. Use the left/right scroll arrows to select each configurable safety system event and repeat steps 2 - 4 to assign the desired Bio-Pump, roller pump, and AutoClamp responses.

Tabl e 5-5 . Configurable Safety System Events

Event Description USED IN

AIR DETECTED BY ABD (ALARM)

AIR IN CARDIOPLEGIA CIRCUIT (ALARM)

AIR IN VARD (ALERT) Occurs when air is detected by the

Occurs when the Transonic™ arterial flow transducer with air bubble sensor detects air.

Occurs when the cardioplegia ultrasonic air/fluid sensor detects air.

upper pair of ultrasonic sensors in the VARD.

RESTING

HEART

YES YES

YES NO

USED IN

BIO-PUMP

CPB

5-24 Operator’s Manual

TOO MUCH AIR IN VARD (ALARM)

Occurs when air is detected by the lower pair of ultrasonic sensors in the VARD.

YES NO

Instructions for Use

System Configuration

Event Description USED IN

RESTING

HEART

LOW BLOOD LEVEL ALERT

Occurs when fluid in the reservoir drops below the position of the

NO YES

yellow level sensor.

LOW BLOOD LEVEL ALARM

Occurs when the fluid in the reservoir drops below the position of

NO YES

the red level sensor.

BIO-PUMP STOP Occurs when the Bio-Pump enters

YES YES

the Stop Mode.

BIO-PUMP COAST Occurs when the Bio-Pump enters

YES YES

the Coast Mode.

BIO-PUMP BACKFLOW (ALERT)

Occurs when negative flow is detected by the TransonicTM arterial

YES YES

flow transducer.

BIO-PUMP LOW FLOW (ALERT)

Occurs when the arterial flow detected by the Transonic

arterial

YES YES

flow transducer drops below the low flow limit selected in the Bio-Pump Setup Screen and the pump RPM is greater than 2000.

USED IN

BIO-PUMP

CPB

BIO-PUMP HIGH FLOW (ALERT)

OVERPRESSURE ALERT: VLP

OVERPRESSURE ALARM: VLP

OVERPRESSURE ALERT: ALP

OVERPRESSURE ALARM: ALP

Occurs when the Bio-Pump is in the Venous Line Pressure Servo Mode and the pump speed exceeds 125% of the speed when servo was engaged.

Occur when the Venous Line Pressure (VLP) limits selected in the Bio-Pump Setup Screen are exceeded. (See “Pressure Mode Selection” on page 5-84.)

Occur when the Arterial Line Pressure (ALP) limits selected in the Bio-Pump Setup Screen are exceeded. (See “Pressure Mode Selection” on page 5-84.)

YES YES

YES NO

YES YES

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System Configuration

Event Description USED IN

OVERPRESSURE ALERT: PR1

OVERPRESSURE ALARM: PR1

OVERPRESSURE ALERT: PR2

OVERPRESSURE ALARM: PR2

OVERPRESSURE ALERT: PR3

OVERPRESSURE ALARM: PR3

OVERPRESSURE ALERT: PR4

OVERPRESSURE ALARM: PR4

OVERPRESSURE ALERT: PR5

OVERPRESSURE ALARM: PR5

Occur when the line pressure limits selected in the Roller Pump Setup Screen are exceeded. (See “Roller Pump Pressure Channel Limit Settings” on page 5-86.)

RESTING

HEART

YES YES

NO YES

USED IN

BIO-PUMP

CPB

OVERPRESSURE ALERT: PR7

OVERPRESSURE ALARM: PR7

OVERPRESSURE ALERT: PR8

OVERPRESSURE ALARM: PR8

PUMP COVER OPEN: PM1

PUMP COVER OPEN: PM2

PUMP COVER OPEN: PM3

PUMP COVER OPEN: PM4

Occur when the line pressure limits selected in the Roller Pump Setup Screen are exceeded. (See “Roller Pump Pressure Channel Limit Settings” on page 5-86.)

Occur when the interlock sensor on the pump cover is lifted off the pump housing.

YES YES

5-26 Operator’s Manual

Tabl e 5-6. Bio-Pump and Roller Pump Response Definitions

Response Definition

Instructions for Use

System Configuration

Stop A Stop response causes the pump speed to go to zero and the motor to enter

Coast (for Bio-Pump only)

Pause (for roller pumps only)

Message Only

the Stop Mode. The pump must be restarted manually after the event is cleared or the safety system is disabled. If a Stop response is executed while the centrifugal pump is in the Servo Mode, the pump will switch to the Manual Mode after it is restarted.

In the Resting Heart mode, a Coast response causes the Bio-Pump speed to reduce to a flow of 0.5 L/min. As the pump speed adjusts to achieve 0.5 L/min, the transient RPM change may not be sufficient to prevent backflow or may be high enough to allow some forward flow. The pump flow will remain at 0.5 L/min until the event is cleared or the safety system is disabled. The pump speed will then automatically ramp up its speed to the previous level. Warning: If the Bio-Pump enters the Coast Mode in response to the “AIR DETECTED BY ABD” alarm, pump flow will remain at 0.5 L/min and will not automatically ramp up after the air is no longer detected by the ABD or after the ABD is turned off. Flow can only be resumed manually after careful assurance that air has been completely removed from the arterial circuit.

In the Bio-Pump CPB mode, a Coast response causes the Bio-Pump speed to be reduced to an RPM of 2000. This RPM may not generate sufficient pressure to prevent backflow, or it may be enough to allow some forward flow. The pump will remain at 2000 RPM until the event is cleared or the safety system is disabled. The pump speed will then automatically ramp up its speed to the previous level.

Warning: If the Bio-Pump enters the Coast mode in response to the “AIR DETECTED BY ABD” alarm, pump speed will remain at 2000 RPM and will not automatically ramp up after the air is no longer detected by the ABD or after the ABD is turned off. Flow can only be resumed manually after careful assurance that air has been completely removed from the arterial circuit.

A Pause response causes the roller pump speed to be temporarily reduced to zero. The speed remains at zero until the event is cleared or the safety system is disabled. The pump will then automatically start and gradually ramp up its speed to the previous/original level.

A Message Only response causes a message about the event to appear in the top line of the message bar. The message may occur concurrent with the other visual and audible cues representing an alert or alarm condition.

No Response

If No Response is selected, then no safety system connection is established between the device and the pump.

The AutoClamp System incorporates a pneumatically powered tube clamp on the arterial line that serves to prevent retrograde flow from the aorta into the venous reservoir when the Bio-Pump events STOP, COAST, BACKFLOW, or LOW FLOW occur.

Tab le 5- 7. AutoClamp Response Definitions

Response Definition

CLOSE A CLOSE response causes the solenoid valve in the AutoClamp Interface

NO RESPONSE

Note: These configuration options are only selectable when running the Bio-Pump CPB mode.

Module to release gas pressure and allow the spring clamp in the Remote Tube Clamp to pinch the tubing. The clamp remains in the CLOSE position until (1) the AutoClamp is disabled or (2) the condition that initiated the clamp to CLOSE has been corrected.

If NO RESPONSE is selected, then no safety system connection is established between the AutoClamp and the Bio-Pump event.

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System Configuration

Configuring User Preferences

The Performer CPB User Preferences screens allow the user the following entry or selection options:

■

Hospital or organization names

■

One or two-sensor Level Detection mode

■

Enabling or disabling the AutoClamp option

■

One-pump or two-pump cardioplegia delivery mode

■

Low Flow Alert

■

Low Hematocrit Alert

■

Low Oxygen Saturation Alert

■

Acoustic Signal Tone quality and volume setting

■

Languages

■

Local date and time

■

New Password

■

Referencing the software version

Press the User Preferences Configuration button and scroll left/right to configure the following settings.

General Data Configuration

1. Enter Hospital name.

2. Enter Organization name, if applicable.

3. Enter Notes, if applicable.

4. Scroll right to view the Miscellaneous Screen.

5-28 Operator’s Manual

Instructions for Use

System Configuration

Miscellaneous

1. In the LEVEL SENSORS window, select whether Level Detection will utilize zero, one or two level sensors. Press the box under the desired configuration (0, 1 or

2) and the green check will move to that box confirming the selection. If one sensor will be used, select the Alert (upper) or Alarm (lower) sensor by pressing the lavender button below the green check. (Bio-Pump CPB mode only)

2. In the AUTOCLAMP window, select whether the AutoClamp System will be used. Press the box under the desired configuration (0 = OFF, 1 = ON) and the green check will move to that box confirming the selection. (Bio-Pump CPB mode only)

3. In the CARDIOPLEGIA MODE window, press to select whether cardioplegia delivery will utilize a ONE PUMP configuration or a TWO PUMP configuration.

4. In the CARDIOPLEGIA MODE window, confirm the drug tube is either 1/8” ID or 1/4" ID. Press the button to change.

5. In the ALERT LIMITS window, confirm the LOW FLOW alert limit value. Press the value to edit. The LOW FLOW pop-up window will appear. Press the Up/Down arrows in the pop-up window to change. Press the edited value to accept.

6. In the ALERT LIMITS window, confirm the low OXYGEN SAT alert limit value. Press the value to edit. The OXYGEN SAT pop-up window will appear. Press the Up/Down arrows in the pop-up window to change. Press the edited value to accept.

7. In the ALERT LIMITS window, confirm the low HEMATOCRIT alert limit value. Press the value to edit. The HEMATOCRIT pop-up window will appear. Press the Up/Down arrows in the pop-up window to change. Press the edited value to accept.

8. In the DISPLAY CONTRAST window, the settings pertain to the brightness/ contrast of the roller pump displays. Press the button for each pump to open the pop-up window that allows the user to adjust the contrast of the corresponding LCD roller pump display on the front of the console.

9. Scroll right to view the Acoustic Signals Configuration Screen.

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System Configuration

Acoustic Signals Configuration

Resting Heart mode only:

1. Press and select VARD ALERT.

2. Press the << or >> buttons to scroll through seven options for acoustic tones and one option for voice (Option 8).

3. Press the > button to preview the acoustic tone option selected in step 2.

4. Press the -/+ buttons to set volume.

Note: The volume of Sound 1 for VARD Alert and VARD Alarm cannot be adjusted.

5. Repeat steps 1 through 4 for each of the following: a. GENERIC ALERT b. VARD ALARM

6. For the VOICE MESSAGES (Option 8): a. Press > to preview the volume for voice messages. b. Press -/+ to set the volume. c. Press << or >> to either enable or disable all of the following voice messages.

■

MESSAGE 1: “Welcome to Performer CPB” will sound at start-up.

■

MESSAGE 2: “Make Your Choice” will sound after successful completion of the Power On Self-Test and when the Home Screen appears.

■

MESSAGE 3: “Treatment Activation” will sound after the Resting Heart button on the Home Screen is pressed.

■

MESSAGE 4: “Enter Password” will sound after the System Configuration button is pressed and the Password Screen appears.

■

MESSAGE 5: “Password Correct” will sound after the System Password is properly entered.

■

MESSAGE 6: “Password Incorrect; Try Again” will sound if the System Password is improperly entered.

■

MESSAGE 7: “See You Next Time” will sound when the Home Button is pressed.

7. Scroll right to view the Password Configuration Screen.

Bio-Pump CPB mode only:

5-30 Operator’s Manual

1. Press and select LEVEL SENSOR ALERT.

2. Press the << or >> buttons to scroll through seven options for acoustic tones and one option for voice (Option 8).

3. Press the > button to preview the acoustic tone option selected in step 2.

4. Press the -/+ buttons to set volume.

5. Repeat steps 1 through 4 for each of the following: a. LEVEL SENSOR ALARM b. VOICE MESSAGES

Instructions for Use

System Configuration

c. ALERT

■

MESSAGE 1: “Welcome to Performer CPB” will sound at start-up.

■

MESSAGE 2: “Make Your Choice” will sound after successful completion of the Power On Self-Test and when the Home Screen appears.

■

MESSAGE 3: “Treatment Activation” will sound after the Bio-Pump CPB button on the Home Screen is pressed.

■

MESSAGE 4: “Enter Password” will sound after the System Configuration button is pressed and the Password Screen appears.

■

MESSAGE 5: “Password Correct” will sound after the System Password is properly entered.

■

MESSAGE 6: “Password Incorrect; Try Again” will sound if the System Password is improperly entered.

■

MESSAGE 7: “See You Next Time” will sound when the Home Button is pressed.

7. Scroll right to view the Password Configuration Screen.

Password Configuration

1. Press the keypad buttons to configure new system administrator password numbers which appear in the “NEW” row.

2. Press the Confirm button to accept the new password.

Language Configuration

1. Press or to select the desired language.

2. Press to confirm the language selection. When confirmed, the letters will change from black to red. The selected language takes effect immediately.

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System Configuration

Date and Time Configuration

1. Press a Time Unit button (year, month, day, hour, or minute) to open a pop-up window displaying the selected unit of time.

2. Press the Up/Down increment buttons to change the value in the pop-up window. Confirm by pressing the new value box in the pop-up window. The new value will appear in the selected Time Unit button.

Software Version

Displays information for service technicians regarding the installed software version in the Performer CPB.

Configure Service Settings

Access to the service configuration settings is restricted to Medtronic service technicians only.

Saving Configuration Settings

The system enables for multiple configurations to be saved and identified as individual PROFILE names. After all configuration settings are made:

1. Press on the Menu Bar. The SYSTEM PROFILE window will appear requesting the user to:

■

Save Changes

■

Save as New Profile

■

Exit Without Saving

5-32 Operator’s Manual

Instructions for Use

System Configuration

2. Press “Save As New Profile” after completing new configuration settings to be saved under a unique file name. The screen will revert to a USER PROFILES screen with a keyboard for entering the name of the new profile.

3. Type the new name using the keyboard. As the letters are entered, they will appear in the blue highlighted bar under ACTIVE PROFILE.

4. Press the bar to accept the new name. The system will save the new profile and add the name to the list under AVAILABLE PROFILES. The new profile also appears as the ACTIVE PROFILE (green highlighted).

5. The screen will revert to the Home screen.

Note: SYSTEM PROFILE (yellow highlighted) is the file that contains the Factory Default settings and cannot be edited or renamed.

Note: When making configuration edits to the active profile that do not warrant creating a new profile name, press SAVE CHANGES. The changes will be saved in the file in the ACTIVE PROFILE window and the screen will revert to the Home screen.

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System Configuration

Navigating in the USER PROFILES Screen

Use NEW to create a new profile name.

1. Press NEW. The screen with the keyboard will be displayed.

2. Type the new profile name. As the letters are entered, they will appear in the blue bar under ACTIVE PROFILE.

3. Press the bar to accept the new name. The system will save the new profile and add the name to the list under AVAILABLE PROFILES. The new profile also appears as the ACTIVE PROFILE (green highlighted).

Note: The Configuration settings in this file will be the same as those in the Factory Default settings (Table 5-1).

Use COPY to create a profile that is a copy of an existing one (created by user).

1. Press the Up/Down scroll arrows to highlight the profile name to be copied.

2. Press COPY. The screen with the keyboard will be displayed. Enter a name for this new profile. As the letters are entered, they will appear in the blue bar under ACTIVE PROFILE.

Note: After changes are made to a profile and are ready to be saved, press the Home button. A window will open with the profile name at the top. SAVE CHANGES must be pressed before the changes become effective and can be displayed when you press the VIEW button.

Use RENAME to change the name of a profile.

1. Press the Up/Down scroll arrows to highlight the profile name to change.

2. Press RENAME. The screen with the keyboard will be displayed. Enter the new name. As the letters are entered, they will appear in the blue bar under ACTIVE PROFILE.

3. Press the bar to accept the new name. The system will save the new profile and add the name to the list under AVAILABLE PROFILES.

Use DELETE to remove a profile from memory.

1. Press the Up/Down scroll arrows to highlight the profile name to delete.

2. Press DELETE. A window will appear asking “DO YOU REALLY WANT TO DELETE THIS PROFILE?”

3. Press the Green check to delete.

5-34 Operator’s Manual

Instructions for Use

System Start-up

Use VIEW to display the configuration settings for a certain profile.

1. Press the up/down arrows to select the profile to be viewed (highlighted in yellow).

2. Press VIEW. The first screen will display a table with NAME, UNITS and TUBE columns for the roller pumps, NAME, ALERT and ALARM columns for the Pressure Channels and a NAME column for the Temperature channels.

3. Press the Right Scroll Arrow. The next screen will display a table of the Safety System responses for the Bio-Pump, the roller pumps, and the AutoClamp.

4. Press the Right Scroll Arrow. The next screen will be a continuation of the table showing Safety System responses for the Bio-Pump, roller pumps and the AutoClamp.

5. Press the Right Scroll Arrow. The last screen will be a table of the selected User Preferences.

6. Press to return to the USER PROFILES screen.

Use the USE button to assign a profile from the list as the ACTIVE PROFILE.

1. Press the Up/Down scroll arrows to highlight the profile name to use.

2. Press USE. The name of the selected profile will appear in the bar under ACTIVE PROFILE.

System Start-up

Home Screens

After the Power On Self-Test (POST) functions indicate PASSED, the display will automatically proceed to the Home Screen (See Figure 5-15).

While in the Home Screen, the user can adjust the height by pressing the console Up/Down switches.

Note: The press-and-release function of the console Up/Down switches are disabled after leaving the Home Screen and entering an operational mode. To adjust the height, the user must press and hold the respective Up or Down switch until the desired height is reached.

Figure 5-15. Resting Heart and Bio-Pump CPB Home Screens

1. Press “RESTING HEART” to operate the Medtronic Resting Heart mode.

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System Start-up

2. Press “BIO-PUMP CPB” to operate an extracorporeal circuit using gravity drainage to a venous reservoir.

3. Press “SYSTEM PROFILE” (or the field with the user icon) to configure the User Profiles.

4. Press “SYSTEM CONFIGURATION” to configure the system settings (see page 5-18).

5. Press “LOAD BIO-PUMP CPB” or “LOAD RESTING HEART” to switch between using these two modes.

Entering Resting Heart Mode

Press the RESTING HEART button on the Home Screen to operate the system when using the Medtronic completely integrated, closed-loop extracorporeal circuit which consists of a Bio-Pump+

Oxygenator, an AFFINITY Device. All non-silicone blood contact surfaces are prepared with Carmeda BioActive Surface unless otherwise specifically noted.

Warning: Only persons thoroughly trained in cardiopulmonary bypass procedures should use this bypass circuit. Operation of the bypass circuit requires constant supervision by qualified personnel for patient safety.

Entering Bio-Pump CPB Mode

Press the BIO-PUMP CPB button on the Home Screen to operate the system when using an extracorporeal circuit with a reservoir.

Screen Design and Operation

The main interface enables the user to interact with the Performer CPB equipment through a color graphic display and a touch screen system that activates the various functions represented on the screen. The display is divided into well-defined zones for every available perfusion mode and consistent information areas are always visible. The touch screen display allows the user to:

■

select the delivery modes

■

monitor the various perfusion parameters

■

display all the parameters (pressures, flows, temperatures)

■

set the safety limits

■

read message alarms and warnings

Resting Heart® Module. The Resting Heart® Module is a

Centrifugal Blood Pump, a Bio-Probe® flow sensor, an AFFINITY® NT

Arterial Filter, and an AFFINITY® Venous Air Removal

®1

5-36 Operator’s Manual

Carmeda® is a registered trademark of Carmeda A.B.

Figure 5-16. Main User Interface Components (Bio-Pump CPB mode)

1. Message Bar

2. Main Menu

3. Cardioplegia Control Screen

4. Main Run Screen

5. Timers

Instructions for Use

System Start-up

The Performer CPB screen also uses unique graphic pictures and icons to display information.

Read-Only Screen Graphics

The screen areas or icons that do not change when pressed are designated as “Read-Only.” These areas or icons provide dynamic information to the user about the status of the components or systems and update as conditions change.

Examples are:

Message Bar

Air in VARD (Resting Heart mode only)

Low Suction (Resting Heart mode only)

Static Function Buttons

Screen areas and icons that enable the user to navigate to a different screen or activate/deactivate a device are designated as static function buttons. The graphics of static function buttons do not change when pressed.

Examples are:

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System Start-up

Home Button

Bio-Pump Setup Button

Roller Pump Setup Button

Cardioplegia Mode Selection Button

Safety System Screen

Patient Information Button

Parameters Screen Button

Trending Screen Button

Events Log Button

Print Button

SAT/HCT Offset Button

Main Menu Button

Calculator

VARD Screen Call-up Button (Resting Heart mode only)

Level Sensor Screen Call-up Button (Bio-Pump CPB mode only)

Dynamic Function Buttons

Dynamic function buttons provide information to the user and are used to activate/deactivate devices. These buttons also change appearance to indicate a change in the status of the device or the system the icon represents.

Examples are:

5-38 Operator’s Manual

■

Air Bubble Detector (ABD)

The gray icon with a red X indicates the ABD is disabled.

Pressing the gray icon enables the ABD, which then changes the icon to green with a green checkmark.

Detecting air causes the ABD icon to change to red, indicating “Air Detected.”

■

Pinch Valve (Resting Heart mode only)

The green icon indicates the pinch valve is closed.

Pressing the green icon causes the pinch valve to open for 0.5 seconds. The icon changes to red while the valve is open.

Instructions for Use

System Start-up

■

Arterial AutoClamp (Bio-Pump CPB mode only)

The yellow icon is used to initiate the AutoClamp Self Te st .

The grey icon with a red X indicates the AutoClamp is off.

Pressing the grey icon turns the AutoClamp to ON. The icon then changes to green with a green checkmark.

Activation of the AutoClamp causes the icon to change to red with an exclamation mark.

■

VARD Servo (Resting Heart mode only)

Pressing the VARD Servo button changes the icon from gray to “colored,” indicating the VARD Servo Mode is enabled.

When the VARD Servo Mode is enabled, the VARD icon in the AAR Screen changes to a dynamic function button. Pressing this button enables and disables the upper ultrasonic sensors for Servo Mode operation.

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System Start-up

Several icons or screen areas are color-coded with the shade lavender to assist the user to easily identify them as dynamic function buttons.

An example is:

■

Cardioplegia Delivery Mode

The two lavender icons with the roller pumps represent the One-Pump Mode for cardioplegia delivery. Pressing this button will change the appearance to represent the Two-Pump Mode for cardioplegia delivery (see below).

The single lavender icon with the roller pumps represents the Two-Pump Mode for cardioplegia delivery. Pressing this button will change the appearance to represent the One-Pump Mode for cardioplegia delivery (see above).

System Alerts and Alarms

System Alerts

The console, CID, and touch screen incorporate distinct visual and audible system alerts intended to elevate the user's awareness when:

■

a safety device is activated

■

user-defined or default operational limits of a system are exceeded

■

an event occurs

■

an electromechanical or software malfunction occurs

Alerts are typically associated with:

■

the system status LED changing to yellow

■

the sounding of a distinctive audible alert tone defined by the user

■

a description of the event(s) in the top line of the message bar

■

(User Option) automatic change in a pump function to prevent or stop the alert condition

System Alarms

For alarms, the console, CID, and touch screen incorporate distinct visual and audible system alerts intended to elevate the user’s awareness when:

■

a safety device is activated

■

user-defined or default operational limits of a system are exceeded

■

an event occurs

■

an electromechanical or software malfunction occurs

The system then, concurrently, may activate user-defined options to automatically stop the malfunction or prevent the limits from being exceeded.

Alarms are always associated with:

5-40 Operator’s Manual

■

Main Run Screen

The Main Run Screen (Figure 5-17) always displays the physiologic parameters pertinent to maintaining the hemodynamic and metabolic support to the patient during cardiopulmonary bypass (CPB). The display differs depending on the current mode, but there are a number of shared components.

Instructions for Use

Main Run Screen

the system status LED changing to red

the sounding of a distinctive audible alarm tone defined by the user

the message bar changing to red

a description of the event(s) in the top line of the message bar

a description of a change in the Bio-Pump status in the second line of the message bar

Resting Heart Main Run Screen

Bio-Pump CPB Main Run Screen

Figure 5-17. Main Run Screens

1. Bio-Pump RPM: Turn the pump speed RPM knob clockwise to increase the RPM of the remote drive motor. Monitor pump speed (RPM) in correlation with blood flow.

Warning: To prevent backflow of the patient’s blood when the pump outlet tubing is open, establish and maintain a minimum pump speed that overcomes line and patient resistance. Use the AutoClamp System on the arterial line in Bio-Pump CPB mode. Failure to do this could allow retrograde flow and exsanguinate the patient.

Warning: All gaseous bubbles have the potential for gaseous emboli and must be dealt with carefully. Using Safety Devices (Arterial Line Air Bubble Detector, VARD) and Safety Systems (Bio-Pump Backflow Alert, AutoClamp) are recommended to aid in the detection and elimination of gaseous bubbles in the extracorporeal circuit.

2. Flow: To display and monitor blood flow, attach the doppler ultrasound flow transducer to the arterial line of the extracorporeal circuit. It is recommended that this placement occurs downstream of the arterial filter. Ensure that the direction of the arrow on the face of the sensor is in the same direction of fluid flow. The sensor will detect flow of both electrolyte solutions and blood.

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Main Run Screen

3. T1 and T2: The Main Run Screen is configured to display two temperatures, T1 and T2. Connect a YSI™ Series 400 compatible temperature probe to the jack labeled T1 on the back of the console to monitor the temperature in the T1 display (see the arterial circuit). Connect a YSI™ Series 400 compatible temperature probe to the jack labeled T2 on the back of the console to monitor the temperature in the T2 display (see the venous circuit).

4. Air Bubble Detector (ABD): The doppler ultrasonic flow probe includes an integral macro-air bubble detector. The ABD icon on the Main Run Screen defaults to the ABD Disabled Mode when the system is powered up. The top line of the message bar will display “ABD OFF.” To activate or enable the air bubble detection function, press the ABD DISABLED icon. When enabled, the ABD icon will change to ABD ENABLED and the display “ABD OFF” will clear from the top line of the message bar. In the event arterial air is detected, the ABD icon will change to AIR DETECTED.

5. Arterial Line Pressure (ALP): To display the arterial line pressure, connect a pressure monitoring line with an isolator between a stopcock in the arterial segment of the extracorporeal circuit and the pressure luer port labeled ALP. Ensure that the portion of the monitoring line from the circuit stopcock to the fluid isolator membrane is thoroughly primed.

Warning: Do not introduce fluid into the male pressure luer connection on the console.

By pressing the Pressure Mode button, the user can change the ALP display to read either systolic , mean , diastolic , or instantaneous pressure.

6. Cardiac Index: In the Patient Information Screen (see “Patient Information” on page 5-100), ensure that the correct patient height (in cm) and weight (in kilograms) are entered. These parameters are then used to calculate the patient's Body Surface Area (BSA) in square meters. Cardiac index represents either the flow in liters per minute per square meter of body surface area (L/MIN/M2) or milliliters per minute per kilogram of body weight (ML/MIN/KG). Press to change the display to view either parameter.

7. Oxygen Cons./Oxygen Deliv.: This display enables the perfusionist to continuously monitor the milliliters per minute of oxygen the patient is consuming or the milliliters per minute of oxygen being delivered to the patient. Oxygen consumption is based on the following calculation: OXYGEN CONS. = 1.39 x (Hct/3) x (.999 - OXYGEN SAT) x BLOOD FLOW x 10. Oxygen delivery is based on the following calculation: OXYGEN DELIV. = 1.39 x (Hct/3) x .999 x BLOOD FLOW x 10. Both equations rely on the continuous input from the Doppler ultrasound probe measuring the blood flow and the input from the optical probe measuring oxy-hemoglobin saturation and hematocit. Press to change the display to view either parameter.

8. Hematocrit: When the probe used to monitor the oxy-hemoglobin saturation of mixed venous blood is connected to the 9.5 mm (3/8 in) connector/cuvette, it will simultaneously detect the hematocrit of the blood and display the value in the Hematocrit window. The unit of measure is percent (%). Press to adjust the low Hematocrit alert using the pop-up window.

9. Oxygen Sat (%): To display the oxy-hemoglobin saturation of mixed venous blood, connect the optical probe to the 9.5 mm (3/8 in) connector/cuvette in the venous segment of the extracorporeal circuit. Press to adjust the low Oxygen Sat alert using the pop-up window.

Resting Heart Mode only:

10. Venous Line Pressure (VLP): To display the venous line pressure, connect a

5-42 Operator’s Manual

pressure monitoring line with an isolator between a stopcock in the venous segment of the perfusion circuit and the pressure luer port labeled VLP. Ensure that the portion of the monitoring line from the circuit stopcock to the fluid isolator membrane is thoroughly primed.

Instructions for Use

Main Run Screen

Warning: Do not introduce fluid into the male pressure luer connection on the console. Zero the transducer (see “Zeroing the Pressure Transducers” on page 5-87). By pressing the Pressure Mode button, the user can change the VLP display to read either systolic , mean , diastolic , or instantaneous pressure. (See Figure 5-34 on page 5-88.)

11. VLP Servo: The VLP servo automates the relationship between pump RPM and changes in venous line pressure (VLP). When the VLP servo is engaged and the venous line pressure becomes more negative, the system automatically reduces pump RPM to facilitate a consistent VLP value.

Note: The VLP servo does not override the Bio-Pump safety system responses for Coast or Stop.

12. VARD Servo: The VARD servo automates the relationship between pump RPM and the occurrence of air in the VARD. When the VARD servo is engaged and air enters the VARD, the system automatically reduces pump RPM to facilitate efficient removal of the air. The VARD servo overrides the pump responses set up for the “Air In VARD” and “Too Much Air In VARD” safety systems. The system will indicate with acoustic and visual indicators when air does enter the VARD.

Bio-Pump CPB Mode only:

13. Level Detection: Used for detecting changes in fluid or blood volume in a reservoir. The Level Detection System utilizes a pair of color-coded sensors placed on the outside surface of a reservoir. The location is user-defined. The reservoir icon indicates the sensors are properly attached and sensing fluid in the reservoir. The Level Detection button enables the sensors so when the fluid/blood level in the reservoir moves above or below the position of a sensor, visual and audible cues occur to alert the user. The Bio-Pump and the roller pumps can also be configured to change their speed in response to the sensors detecting level changes.

Warning: The level detection system must be properly set up and enabled prior to clinical use. Undetected emptying of the reservoir may result in gaseous emboli being pumped to the patient with attendant risk of death or serious injury.

Warning: Verify the level detection system functions properly with the particular reservoir being used.

Warning: The performance of the level detection system must be verified before each use.

14. AutoClamp: Displayed when the AutoClamp System is enabled and a pneumatically powered tube clamp is placed on the arterial line. The clamp can be configured to close when the Bio-Pump run mode changes (STOP, COAST, LOW FLOW) or the arterial flow sensor detects backflow. Closing the clamp prevents retrograde flow from the aorta into the venous reservoir and prevents introducing air into the arterial line. The AutoClamp icon on the Main Run Screen defaults to the SELF TEST READY Mode when the system is powered up. Press to conduct the Self Test. When passed, the icon changes to AUTOCLAMP OFF. When pressed, the icon changes to AUTOCLAMP ON. When triggered to close, the icon changes to AUTOCLAMP CLOSED. When the red AUTOCLAMP CLOSED is pressed, the icon changes to the AUTOCLAMP OFF icon.

Warning: Prior to configuring the AutoClamp to CLOSE when the Bio-Pump enters the COAST mode, it is the user's responsibility to test the extracorporeal circuit and confirm the conduct of perfusion at their institution does not generate arterial backflow when the Bio-Pump enters the COAST mode or when the Bio-Pump speed is manually reduced to the “detent” position.

Operator’s Manual 5-43

Chapter 5

Main Run Screen

Checking the Battery

Integrated batteries provide uninterruptible battery backup power in the event wall power is lost. During AC power loss, fully charged batteries will supply enough power to operate a fully loaded system for 30 minutes.

Fully loaded is defined as follows:

PM1: 1000 mL/min with 9.5 mm (3/8 in) x 2.4 mm (3/32 in) tubing

PM2: 100 mL/min with 6.4 mm (1/4 in) x 1.2 mm (1/16 in) tubing

PM3: Stopped

PM4: 400 mL/min (150 mm Hg back-pressure) with 6.4 mm (1/4 in) x 1.2 mm (1/16 in) and 3.2 mm (1/8 in) x 1.2 mm (1/16 in) tube set (2 tubes)

Pinch valve: Cycled every 2 minutes

Bio-Pump: 4.0 L/min

Warning: If a partially charged battery is used, there may be less than 30 minutes of battery power available.

Warning: When the Uninterruptible Power Supply (UPS) converts the system to battery power, ALL pumps, pump functions, safety systems, alerts, alarms, monitors, controls, the Pinch Valve and the Central Information Display (CID) are active and function the same as when the system is on AC power.

The batteries will charge, as needed, while the system is operating from AC wall power.

To check the battery charge:

1. Press to display the battery charge level in minutes. Battery charge level should be checked before each case.

2. Start the Bio-Pump remote drive motor and each roller pump.

3. Unplug the system from AC wall power. Confirm that the system automatically converts to battery power.

■

The power status icon will change to “battery” and display the time remaining battery charge

■

The message bar will display “BATTERY MODE”

■

The system status LED will change to yellow

■

The audible alerts will sound

5-44 Operator’s Manual

Instructions for Use

Main Run Screen

Warning: If the system does not convert to battery power, contact a Medtronic service technician.

4. Monitor the time remaining in the power status icon as the battery discharges. Reducing the power load on the system will extend the duration of battery backup power.

5. When the time remaining reaches 5 minutes:

■

the system status LED changes to red

■

the message bar changes to red

■

the top line of the message bar reads “LOW BATTERY”

■

the audible alarm tone sounds

6. Plug the system back into the AC wall power. Confirm that the system automatically converts to AC wall power.

■

the power status icon will change to “AC”

■

“BATTERY MODE” will clear from the top line of the message bar

■

the system status LED will change to green

■

the audible alerts will stop

Operator’s Manual 5-45

Chapter 5

Timers

Timer Overview

The various timers on the Perfusion Screen are shown in Figure 5-18. The timers appear and function the same in both Resting Heart and Bio-Pump CPB modes.

1. Pump Timer

2. Clamp Timer

3. Rezero Button

4. Auxiliary Timer

Pump and Clamp Timer Operation

The screen buttons for the pump timer and the clamp timer function exactly the same.

Start Timers

Pump Timer

REZERO BUTTON START BUTTON STOP BUTTON

Clamp Timer

Figure 5-18. Perfusion Screen Timers

5-46 Operator’s Manual

REZERO BUTTON START BUTTON STOP BUTTON

Instructions for Use

Timers

To start a Timer, press the green Start button. The following will occur when the Start button is pressed:

■

the green icon will change to the red Stop button

■

the elapsed time in minutes and seconds will be displayed

■

the clock time when the Start button was pressed will be displayed

Stop Timers

Pump Timer

STOP BUTTON REZERO

BUTTON

START BUTTON

Clamp Timer

STOP BUTTON REZERO

BUTTON

START BUTTON

To stop the Timer, press the red Stop button. The following will occur when the Stop button is pressed:

■

the red icon will change to the green Start button

■

the elapsed time will be displayed

■

the clock time when the Stop button was pressed will be displayed and will immediately change to the Rezero button

To re-start the Timer, press the green Start button. The following will occur when the Start button is pressed:

■

the green icon will change to the red Stop button

■

the elapsed time will resume where it stopped

■

the original clock time when the Start button was pressed will be displayed

■

the clock time when the Stop button was pressed will be displayed

Press or to reset the timer to 000:00.

Note: Repeated clock times when the Start and Stop buttons were pressed can be viewed using the Events Log Screen.

Pressing the Pump Timer Start button is also linked to the following:

■

the saving of the perfusion data for download to the CompactFlash® memory card

■

the tracking of the data for trending

■

the saving of the perfusion data for printing

Operator’s Manual 5-47

Chapter 5

Timers

Auxiliary Timer

■

the enabling/disabling of the alarm “BIO-PUMP EXCESSIVE STOP”

■

the enabling/disabling of the alert “HEMATOCRIT: LOW VALUE”

■

the enabling/disabling of the alert “OXYGEN SATURATION: LOW VALUE”

Note: If the pump timer is not put into the Stop Mode within 1 minute after the Bio-Pump is stopped,

■

the system status LED will change to red

■

the message bar will change to red

■

audible alarm tones will sound

■

the top line of the message bar will read “BIO-PUMP EXCESSIVE STOP”

To silence the alarm, press the alarm mute button once.

To reset the alarm, press the red Stop button on the pump timer.

Pressing the Clamp Timer Start and Stop button is also linked to the following:

■

the enabling and disabling of the alert “NEXT CARDIOPLEGIA DOSE IS DUE”

To start the auxiliary timer, press the green Start button. The following will occur when the Start button is pressed:

■

the green icon will change to the red Stop button

■

the elapsed time in minutes and seconds will be displayed

■

the clock time when the Start button was pressed will be displayed

START BUTTON

REZERO BUTTON Press to reset the timer to 000:00.

To stop the auxiliary timer, press the red Stop button. The following will occur when the Stop button is pressed:

■

the red icon will change to the green Start button

■

the Rezero button will be displayed

5-48 Operator’s Manual

Cardioplegia

Delivery Mode Selection

The system can deliver cardioplegia in two distinct modes, a Two-Pump Delivery Mode and a One-Pump Delivery Mode. When the Perfusion Operations Screen is first opened, the area defined as the Cardioplegia Control Screen defaults to display graphics for the previous delivery mode used.

Two-Pump Delivery Mode

The Two-Pump Delivery Mode uses the pump identified as PM4 for regulating the delivery of the blood portion of the cardioplegia mixture (see Figure 5-18). The pump identified as PM3 is used for regulating the delivery of the drug portion of the cardioplegia mixture. In the two-pump configuration, both pumps operate in tandem, with the blood pump (PM4) designated as the master pump and the drug pump (PM3) designated as the slave pump. The master pump Start/Stop button and pump speed RPM knob operate both pumps.

One-Pump Delivery Mode

Instructions for Use

Cardioplegia

The One-Pump Delivery Mode uses the roller pump identified as PM4 (See Figure 5-18). The ratio of the desired blood and drug mixture is achieved by putting two tubing segments of different dimension in PM4. Then PM3 can be used as a “free” pump (left heart venting, hemoconcentration, etc). In the one-pump configuration, each pump is independently operated using its dedicated Start/Stop button and pump speed RPM knob.

Figure 5-19. Two-Pump and One-Pump Cardioplegia Delivery Modes

1. Two-Pump (default) screen display.

2. One-Pump screen display.

3. Switches to the One-Pump configuration when pressed.

4. Switches to the Two-Pump configuration when pressed.

5. Allows the selection of either 6.4 mm (1/4 in) or 3.2 mm (1/8 in) drug tubing ID to be used in PM3 of the two-pump configuration.

6. Allows the selection of either 6.4 mm (1/4 in) or 3.2 mm (1/8 in) drug tubing ID to be used in the one-pump configuration.

7. Pressing the green checkmark accepts the configuration (one-pump or two-pump) and the tubing dimensions for the one-pump or two-pump configuration.

Operator’s Manual 5-49

Chapter 5

Cardioplegia

Preview Buttons

After the one-pump or two-pump configuration is accepted, a sequence of preview buttons appears, which allows for specific setup, delivery, or timer settings.

Volume Tracking

Setup Parameters

Run Timers Screen

1 3

Figure 5-20. Screen Preview Buttons

Screen

Delivery Parameters Screen

1. When pressed, will preview the Cardioplegia (CPG) Setup Parameters Screen.

2. When pressed, will preview the CPG Delivery Parameters Screen.

3. When pressed, will preview the CPG Run Timers Screen.

Cardioplegia Blood:Drug Ratio

The volume tracking setup parameters are the same for both the One-Pump and Two-Pump Delivery Modes, with the exception of the Ratio button that is found only in the screens for the Two-Pump Delivery Mode.

Note: The system will track the cardioplegia volume delivered based on the combined flows from the master pump (blood) and the slave pump (drug). These flows are a function of the tube sizes entered in the Cardioplegia Delivery Mode Selection Screen and the pump RPM.

5-50 Operator’s Manual

Instructions for Use

Cardioplegia

Figure 5-21. Entering the Two-Pump Blood:Drug Ratio Parameter

To enter the blood:drug ratio:

1. Press the Blood:Drug Ratio button to change the blood:drug ratio in the pop-up window during setup or to edit during use.

2. Press the Up or Down arrow to select the desired value for the blood cardioplegia element. The range is from 0 to 15.

3. Press the Up or Down arrow to select the desired value for the drug cardioplegia element. The range is from 0 to 15.

4. Accept the selected ratio by pressing the label with the ratio and return to the full setup menu.

Cardioplegia Dose

The amount and duration of cardioplegia input to the patient can be controlled in a variety of ways. The Dose Mode button indicates the mode that will automatically stop the cardioplegia pump.

Entering Cardioplegia Dose Settings - Volume Mode, Manual Mode or Time Mode

Volume Mode Manual Mode Time Mode

Figure 5-22. Configuring Cardioplegia Dose Settings

1. To track cardioplegia dosage manually, press the Volume Mode button to change to the Manual Mode. (See Figure 5-22.) The Manual Mode button will appear, indicating that the user must manually stop the pump by either (a) pressing the Start/Stop button on the Cardioplegia Pump Control Panel, or (b) pressing the Volume Tracking Stop button when the desired amount of cardioplegia has been delivered.

2. To track cardioplegia dosage by time, press the Manual Mode button to change to the Time Mode. (See Figure 5-22.) The Time Mode button will appear, indicating that the cardioplegia pump will automatically stop when a user-preset delivery time (in minutes) has been reached.

3. Press to open the Dose Time pop-up window and enter the desired time in minutes.

4. To track cardioplegia dosage by volume, press the Time Mode button to change to the Volume Mode. (See Figure 5-22.) The Volume Mode button will appear, indicating that the cardioplegia pump will automatically stop when a user-preset dose of cardioplegia (in milliliters) has been infused.

5. Press to open the Dose Volume pop-up window and enter the desired volume in milliliters.

Operator’s Manual 5-51

Chapter 5

Cardioplegia

Cardioplegia Volume and Time Tracking

Total Dose Pop-up Window Time Between Doses

Pop-up Window

Figure 5-23. Cardioplegia Volume and Time Tracking

1. displays the total of the cumulative volume of the cardioplegia mixture delivered from each dose. Press to edit this volume using the Total Dose pop-up window.

2. Press to set the Time Between Dose using the Time Between Doses pop-up window.

Note: The Time Since Last Dose timer continues to run until is pressed.

5-52 Operator’s Manual

Time to Next Dose

3 4

Time Since Last Dose

3. Time to Next Dose: When this timer reaches 00:00,

■

an audible tone sounds

■

the system status LED changes to yellow

■

the top line in the message bar displays “NEXT CARDIOPLEGIA DOSE DUE”

4. When is pressed, it changes between Time to Next Dose and Time Since Last Dose displays.

5. Time Since Last Dose: When this timer reaches the user-set value displayed in the Time Between Dose button,

■

an audible tone sounds

■

the system status LED changes to yellow

■

the top line in the message bar displays “NEXT CARDIOPLEGIA DOSE DUE”

Cardioplegia Circuit and Delivery Parameters

Instructions for Use

Cardioplegia

Setup Parameters Screen Delivery Parameters Screen

1. Press to view the Delivery Parameters Screen.

2. Displays the total flow from PM4 (One-Pump Mode) or total flow from PM4 and PM3 (Two-Pump Master/Slave Mode).

3. Displays the pressure measured at PR4. To set up the pressure monitoring circuit, follow the procedures in “Pressure Monitoring Sets with Air/Fluid Isolators Setup” on page 5-88 and see Figure 5-33. Zero the transducer following the procedures in “Zeroing the Pressure Transducers” on page 5-87 and see Figure 5-32. Select safety limits for cardioplegia delivery (see Figure 5-31).

4. Displays the status of the cardioplegia air bubble detector. The default status of the CPG air detector is “enabled.” If a fluid-filled line from the CPG circuit is properly seated in the sensor, the icon will appear green. If the sensor is not detecting a fluid-filled line or it is detecting air in the CPG circuit:

■

the icon will be red

■

an audible alert tone will sound

■

the system status LED will display yellow

■

the top line of the message bar will display “AIR IN CARDIOPLEGIA CIRCUIT”

After completing de-airing of the cardioplegia circuit, ensure a fluid filled segment of tubing from the outlet of the roller pump is properly seated into the cardioplegia Air Bubble Detector.

■

Open the tube latch on the cardioplegia Air Bubble Detector

■

Slide the primed segment into the opening, then close the latch.

Pressing the Cardioplegia ABD icon when it is either green or red will disable the ABD and:

■

change the icon to gray

■

sound the audible alert tone

■

change the system status LED to yellow

■

display “CARDIOPLEGIA AIR SENSOR DISABLED” in the top line of the message bar

Warning: A gray CPG air detector icon indicates the sensor is disabled and will not generate an alarm if air enters the cardioplegia circuit.

Operator’s Manual 5-53

Chapter 5

Cardioplegia

5. Displays the temperature measured using a YSI™ Series 400 Compatible temperature probe connected to T3 on the HST Module.

Cardioplegia Delivery: Clinical Use

Ensure the following before initiating delivery of cardioplegia:

■

A primed segment of the 6.4 mm (1/4 in) x 1.2 mm (1/16 in) CPG circuit tubing between the CPG pump outlet and a bubble trap is properly seated in the 6.4 mm (1/4 in) air sensor.

■

The cardioplegia ABD is enabled and the icon is green.

Warning: A gray CPG air bubble detector icon indicates the sensor is disabled and will not generate an alarm if air enters the cardioplegia circuit. Press the gray icon to enable the CPG air detector indicated by a green icon.

■

The desired value (mm Hg) for PR4 (cardioplegia) pressure alert is set and the desired value (mm Hg) for cardioplegia pressure alarm is set. See Figure 5-31 to set pressure alert and alarm values.

■

The desired roller pump response settings are properly configured for the events “Air in Cardioplegia Circuit,” “PR4 Pressure Alert,” and “PR4 Pressure Alarm.”

■

The desired Bio-Pump response settings are properly configured for the events “Air in Cardioplegia Circuit,” “PR4 Pressure Alert,” and “PR4 Pressure Alarm.”

■

The desired cardioplegia dose volume or delivery time are entered.

■

A temperature probe from T3 on the HTS Module is connected to the temperature port on the cardioplegia set.

Note: Pressing

Note: In the Two-Pump Mode, pressing the Start/Stop button on PM4 (master pump)

will simultaneously start PM3 (slave pump). These pumps will independently rotate at the speed necessary to achieve the blood:drug ratio displayed in the Ratio button

5-54 Operator’s Manual

Setup Parameters Screen Delivery Parameters Screen

1. Press to begin volume tracking.

■

The Delivery Parameters Screen appears.

■

The green Volume Tracking Start button will change to the red Volume Tracking Stop button .

■

The Cardioplegia ABD status changes from “Standby Mode” to “Active Mode.”

does not start the cardioplegia roller pump(s).

2. Press the cardioplegia roller pump (PM4) Start/Stop button to start infusion of cardioplegia. Turn the RPM knob to achieve the desired flow. Monitor the CPG flow (mL/min), line pressure (mm HG), and solution temperature (T3).

Instructions for Use

Cardioplegia

During Cardioplegia Infusion

1. Displays the cumulative volume delivered (mL) resulting from repeat infusions.

2. Displays the volume delivered (mL) during the current infusion.

3. Displays the calculated time remaining (minutes:seconds) before the preset dose is delivered and the pump automatically stops.

Note: In the Manual Mode, this timer counts up the elapsed time of cardioplegia delivery.

4. When the preset volume

■

the cardioplegia pump(s) will automatically stop (Volume and Time Modes

or preset time is reached:

only)

■

an audible tone will sound

■

the system status LED will momentarily change to yellow

■

the top line of the message bar will display “DOSE DELIVERED”

■

the Setup Parameters Screen will appear

■

The Time Since Last Dose timer will begin . It begins counting up starting with 00:00 when the cardioplegia pump is automatically or manually stopped.

■

The Time to Next Dose timer will begin . Starting with the minutes set in the Time Between Doses button, it begins counting down when the cardioplegia pump is automatically or manually stopped.

Operator’s Manual 5-55

Chapter 5

Cardioplegia

5. Press to manually stop CPG delivery if using the Manual Mode . When pressed,

■

the CPG roller pump(s) will stop

■

the Setup Parameters Screen will appear

■

the Time Since Last Dose timer will begin

■

the Time to Next Dose timer will begin

Note: Pressing the Stop button on the roller pump control panel stops CPG infusion but it does not stop CPG volume tracking. To stop volume tracking, press the red Volume Tracking Stop button.

Cardioplegia Delivery Air Detection Alerts and Alarms

Indicates the CPG ABD is disabled and will not detect air in the circuit. When disabled,

■

the system status LED will be yellow

■

an audible alert tone will sound

■

the top line of the message bar will display “CARDIOPLEGIA AIR SENSOR DISABLED”

Indicates the CPG ABD is enabled, the 6.4 mm (1/4 in) air sensor detects a fluid-filled line, and the CPG ABD is in “Standby Mode.”

5-56 Operator’s Manual

■

Used to test the CPG ABD when priming and recirculating the CPG circuit.

■

The ABD icon will change to red if air is detected, but it will not generate an alarm condition.

Instructions for Use

Cardioplegia

Indicates the CPG ABD is enabled, the 6.4 mm (1/4 in) air sensor detects a fluid-filled line, the CPG ABD is in the “Active Mode,” and volume tracking is on.

Indicates air detected by the CPG ABD and initiates an alarm condition that includes:

■

the sounding of audible alarm tones

■

the system status LED changing to red

■

the message bar changing to red

■

the top line of the message bar displaying “AIR IN CARDIOPLEGIA CIRCUIT”

■

the CPG roller pump changing to the Stop Mode

To re su me CP G d e l i v er y,

■

mute the alarm

■

ensure all air in the circuit is thoroughly purged

■

reset the CPG ABD and ensure the icon is green

Note: When CPG delivery is stopped due to an alarm condition, volume tracking is not reset.

■

turn the pump speed RPM knob fully counterclockwise

■

press the Start/Stop button, slowly turn the pump speed RPM knob clockwise, and resume CPG delivery

Operator’s Manual 5-57

Chapter 5

AAR Controller - Venous Air Removal Device (Resting Heart mode only)

Overview

The Medtronic® AAR Controller and the Medtronic® Affinity® Venous Air Removal Device (VARD) combine to form a safety system for sensing air in the Resting Heart™ System and then activating a pinch valve that opens a vacuum line for removing air that may enter the venous circuit. This minimizes the probability of venous air reaching the Bio-Pump and potentially being transmitted to the patient.

Two pairs of ultrasonic fluid sensors in the VARD will detect changes in the air/fluid level within the air separation portion at the inlet of the device. When the level drops below the sensors, the AAR Controller software opens the pinch valve.

An air purge line is connected from the luer port at the top of the VARD to a blood collection canister. The canister is connected to a regulated wall vacuum source. The air purge line is placed in a mechanical pinch valve on the Performer CPB console. The normal resting position of the pinch valve is closed. When air is detected, the valve is opened to remove the air, then immediately returned to the closed position.

The AAR Controller - VARD Run Screen includes the following visual alert and alarm indications and icons representing the status of functional components (see Figure 5-24).

Figure 5-24. The AAR Controller and VARD Run Screen

1. Press the VARD Call-up button to open the operation of the AAR Controller and VARD.

2. The yellow “Air In VARD” read-only icon appears when the level drops below the first (upper) pair of sensors and:

■

a distinct audible alert tone will sound

■

the system status LED will change to yellow

■

the top line of the message bar will display “AIR IN VARD”

■

The pinch valve will open, allowing wall vacuum to suction the air out of the VARD until the upper pair of ultrasonic sensors detect no remaining air/blood mixture in the upper area of the VARD.

■

The AAR Controller then closes the pinch valve, the yellow Air In VARD icon clears, the audible alert tone ceases, the system status LED returns to green, and “AIR IN VARD” clears from the top line of the message bar.

5-58 Operator’s Manual

Medtronic R5400022 Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

1 Introduction 1-1

2Safety2-1

3 Technical Specifications 3-1

4 Installation 4-1

5 Instructions for Use 5-1

6 Cleaning and Maintenance 6-1

7 Troubleshooting 7-1

8 Warranty 8-1

A Index A-1

Introduction

System Description

System Overview

Indications for Use

Contraindications

Warnings

General

AAR Controller

AutoClamp System

Battery/UPS

Main Power Switch

Central Information Display (CID)

Tubing

Roller Pump

Handcrank

Bio-Pump

Power On Self-Test (POST)

Air Bubble Detector (ABD)

Cautions

Safety

Safety Standards

Disposables and Accessories

Main Power Supply Failure

Electromagnetic Disturbance

Elimination of the Disposable Material

End of Life Disposition

Calibration

Technical Documentation

Replacing Fuses

Equipotential Connection

Battery Pack Disposal

Technical Specifications

General Data

Technical Features

Electromagnetic Emissions and Immunity Declarations

Emissions Declaration

Immunity Declaration

Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and Performer CPB Equipment

Monitoring System for Hematocrit, Temperature and O2 Saturation

Temperature Probes

Battery Supply System (UPS)

IEC 60601-2-16 Compliance Chart

Installation

Installation

Installation Checklist and Commissioning

VISUAL INSPECTION

FUNCTIONAL INSPECTION

ELECTRICAL SAFETY CHECK PER IEC EN 60601-1 REGULATIONS

Instructions for Use

Console

External Operational Controls

Front Panel - Controls and Displays

System Status LEDs (Green, Yellow, and Red)

Bio-Pump Control Panel

Roller Pump, Roller Inserts, Tube Inserts, and Tubing

Roller Pumps

Roller Insert

Tube Inserts

Tubing

Connections for Peripheral Components

CompactFlash® Memory Card with PCMCIA Adapter Installation

System Configuration

Preparation for Use

Password Protection

Configuration Mode Screens

Menu Bar

Configuration of the Roller Pumps, Pressure Transducers, and Temperature Channels