Bomba de Circulacion Medtronic

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PERFORMERCPB

c


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Operators Manual

PERFORMER CPBAn Advanced Extracorporeal Circulatory Support System

cManufactured by

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

Distributed Exclusivelyby Medtronic, Inc.


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Medtronic Confidential

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A14113002 Rev. 2.0

Operators Manual i

Explanation of symbols on package labeling

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

Conformit Europenne (European Conformity). This symbol means that the device fully

complies with European Council Directive MDD 93/42/EEC (14 June 1993, concerningmedical 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 inaccordance with UL 60601-1/CAN/CSA C22.2 No. 601.1, IEC 60601-2-16 71NL.

This Way Up

Fragile, Handle with Care

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

0123

xx Kg

MAX


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Bio-Pump

Flowmeter/ABD

Class II (Double Insulated) Equipment

Open Here

Warning, Crushing Hazard: Finger

Pneumatic Pressure Range

Atmospheric Limitation


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Operators Manual iii


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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

2 Safety 2-1

Safety Standards 2-2

Disposables and Accessories 2-2

Main Power Supply Failure 2-2

Electromagnetic Disturbance 2-3

Elimination of the Disposable Material 2-3End 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 O2Saturation 3-10

Temperature Probes 3-11

Battery Supply System (UPS) 3-11

IEC 60601-2-16 Compliance Chart 3-12

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


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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

Aler ts 7-27

8 Warranty 8-1

IMPORTANT NOTICE - LIMITED WARRANTY 8-2

IMPORTANT NOTICE - LIMITED WARRANTY 8-3

A Index A-1


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PERFORMERCPB 0

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Operators Manual 1-1

1Introduction1

System Description 1-2

System Overview 1-2

Indications for Use 1-5

Contraindications 1-5

Warnings 1-5Cautions 1-9


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Chapter 1System Description

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System Description

The Performer CPB System, hereafter referred to as the Performer CPB, is anelectromechanical extracorporeal support device used during cardiopulmonary

bypass procedures. It is an integrated console that can provide total circulatorysupport of the cardiopulmonary system using the MedtronicBio-PumpCentrifugalBlood Pump, hereafter referred to as the Bio-Pump.

System Overview

Total extracorporeal support of the cardiovascular system is accomplished by usingthe Bio-PumpCentrifugal Blood Pump. The Bio-Pump is the exclusive device on thePerformer 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 panelof the Performer CPB console. Flow measurement is accomplished using a reusableultrasonic flow transducer that is noninvasively attached to the arterial line of theextracorporeal 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). Thepump speed RPM knob has a minimum RPM mechanical stop, or detent, thatprevents an unintentional reduction of RPM below 2000. The user must press downon the detent lever while turning the knob counterclockwise to purposefully reduce theRPM below 2000. The minimum RPM detent lever does not affect increasing theRPM.

Integral to the Performer CPB are four roller pumps, each with an independentStart/Stop button, a 3-turn roller speed control knob and a LCD for monitoring flow orRPM. The roller pumps are indicated for moving fluids through an extracorporealcircuit that incorporates a flexible tube. The roller pumps are not indicated for use insupporting 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 capableof 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 amaximum flow of 0.6 L/min. PM3 and PM4 can be configured via the CID so that bothpumps operate in tandem, with PM4 designated as the master pump and PM3designated as the slave pump. The master pump Star t/Stop button and pump speedRPM knob operate both pumps.

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

The interchangeable roller pump inserts are factory calibrated for providing optimalocclusion for standard sizes of polyvinyl chloride (PVC) tubing available for medicaluse. Factory-calibrated roller pump inserts are also available when using 2 tubes in asingle raceway.

The Performer CPB provides perfusion monitoring via:

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


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Temperature monitoring using YSI1Series 400 probes for 8 temperaturesincluding venous line, arterial line, cardioplegia delivery, and the remainder userdefined.

Flow monitoring for the arterial line using a reusable Transonic2ultrasonic flow

probe, which noninvasively connects directly to the arterial line tubing. This flowprobe also serves to detect backflow in the arter ial circuit. Flow data combinedwith patient body surface area entered in the CID also provides for continuousmonitoring of cardiac index.

Oxygen saturation and hematocrit monitoring using an opto-electric sensor,which couples with a dedicated disposable cuvette that is integrated into theextracorporeal circuit. This data, in combination with the information obtainedfrom the flow transducer, is used to calculate and display oxygen consumption onthe 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 consistsof a 30.73 cm (12.1 in) color graphic display (256 colors, 800 x 600 pixel) incombination with a touch screen system to activate the various functions representedon the screen. The display is divided into well-defined zones for the individualperfusion modes and uses unique graphic pictures and icons to display information.Critical information areas are always visible. The touch screen display allows theuser to:

display all desired perfusion parameters

input patient information

configure pump responses to activation of safety devices and events that occurduring 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 toelevate the user's awareness when a safety sensor is activated and whenuser-defined or default operational limits of a system are exceeded. The PerformerCPB enables the user to configure integrated safety links between the following safetysensors and the Bio-Pump and the roller pumps:

Air Bubble Detection (ABD) of macro-air in the arterial circuit is integral to theultrasonic flow monitoring system. The system can be configured by the user tocause the Bio-Pump to either Stop or Coast in response to this sensor beingactivated and prevent transmission of air to the patient. The user can alsoconfigure this safety link to not change the Bio-Pump function, but only producevisual and audible alarm cues.

Air bubble detection of macro-air in the cardioplegia circuit, using an ultrasonictransducer mounted to the side of the console that couples directly to thecardioplegia delivery tubing. The user can configure the cardioplegia delivery

pump (PM4) to either Stop or Pause in response to this event and preventtransmission of air to the heart. The user can also configure this safety link to notchange the roller pump function but only produce visual and audible alarm cues.

1 YSI is a registered trademark of YSI Incorporated.2 Transonic is a registered trademark of Transonic Systems Inc. Corporation.


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Active Air Removal (AAR) technology integral to the Performer CPB is used inconjunction with a dedicated disposable Venous Air Removal Device (VARD) forvenous air sensing and automatic removal. This prevents air entering the venousline 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 theBio-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 usercan also configure this safety link to not change the Bio-Pump function, but onlyproduce visual and audible alarm cues. The level detection system is only utilizedwhen 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 fromthe aorta into the venous reservoir if the Bio-Pump run mode changes. When theBio-Pump enters either the STOP or COAST mode, or the pump speed ismanually reduced to 2000 RPM, there exists the potential for arterial retrogradeflow and entrainment of air into the arterial line from around the aortic cannulationsite. This poses a hazard to the patient if the pump is restarted before air isremoved. The AutoClamp System can be configured to automatically clamp thearterial line when the Bio-Pump speed changes, prevent retrograde flow andthereby prevent the potential to entrainment air around the aortic cannulation site.The AutoClamp System is only utilized when operating in the Bio-Pump CPBmode.

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

The Performer CPB provides an uninterruptible power supply (UPS) that will providebattery power to operate the system for a minimum of 30 minutes with a fully loadedsystem (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 auser-defined option for two-pump blood and drug proport ioning from 0:1 (puredrug) 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 desiredvenous line pressure. This function is particularly useful when operating theMedtronicResting Heart System and optimizing the relationship betweenblood 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 bestored electronically and then later formatted for generating reports.

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


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IntroductionIndications for Use


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Indications for Use

The MedtronicPerformer CPB Advanced Extracorporeal Circulatory SupportSystem is indicated for use up to 6 hours in the extracorporeal circulation of fluids for

cardiopulmonary bypass procedures, when used by a qualified medical professionalwho is experienced in the operation of this or similar equipment.

The Bio-PumpCentrifugal Blood Pump is indicated for use in pumping blood throughan extracorporeal perfusion circuit for extracorporeal circulatory support for periodsappropriate 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

General

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

Only trained and qualified medical personnel should operate and monitor thePerformer CPB.

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

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

The Performer CPB enables the user to change the configuration of the defaultfactory settings. Reconfiguration in regards to how components respond to eventsand assurance that users are properly trained to operate the Perfusion Screensmust be appropriately controlled by the user institution. Failure to establish suchcontrols may result in user error that could result in patient injury or death.

Following standard practices for electronic devices, closely monitor the systemwhen 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) orfluctuations in the alternating current (AC) power line voltage may compromiseperformance or damage the equipment.

Portable and mobile radio frequency (RF) communication devices may affect theoperation of this system. (See Electromagnetic Emissions and Immunity

Declarations on page 3-6.) A standby Bio-ConsoleExtracorporeal Blood Pumping Console should be

available during cardiopulmonary bypass procedures.

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

Do not kink the VARD sensor cable.


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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 patientresistance. Failure to do this could allow retrograde flow and exsanguinate thepatient.

All gaseous bubbles have the potential for gaseous emboli and must be dealt withcarefully. Use of Safety Devices (Arterial Line Air Bubble Detector, VARD, LevelDetection, AutoClamp) and Safety Systems (Bio-Pump Backflow Alert) isrecommended to aid in the detection and elimination of gaseous bubbles in theextracorporeal circuit.

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

A fluid isolator is necessary in the pressure monitoring line to prevent contact ofsterile fluid path with the instrument and damage to the instrument and pressuresystem.

Do not bypass the fluid isolator/filter in the pressure lines for the pressureconnectors (PR1 through PR8, ALP, and VLP) or fluid could enter the transducerand 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 withelectrocautery usage; this may compromise the temperature values measuring.

The device has been designed and tested in conformity with the Electro-MagneticCompatibility standard EN60601-1-2 (2003). I t is advisable, however, to avoid itsuse in the presence of electromagnetic fields or other equipment causinginterference (eg, cellular phones). Special information regarding installation, use,and precautions are described in Electromagnetic Emissions and ImmunityDeclarations on page 3-6.

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

The equipment is not protected against defibrillator discharges.

AAR Controller

Do not operate the Active Air Removal (AAR) system with device or componentsother than the MedtronicResting Heart Module. There are no safety orperformance data known to Medtronic that establish compatibility of any othermanufacturer's device or components with the AAR system. Any substitution ofcomponents becomes the responsibility of the user. Such substitution will voidMedtronic's warranty and the user will bear full responsibility for any adverseconsequences stemming from such use.

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

AutoClamp System

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 patientresistance. Use the AutoClamp System on the arterial line. Failure to do this couldallow retrograde flow and introduce air into the arterial circuit.


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Prior to configuring the Arterial AutoClamp to CLOSE when the Bio-Pump entersthe COAST mode, it is the user's responsibility to test their extracorporeal circuitand confirm the conduct of perfusion at their institution does not generate arterialbackflow when the Bio-Pump enters the COAST mode or the Bio-Pump speed ismanually reduced to the detent position.

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

If the Bio-Pump enters the Coast Mode in response to the AIR DETECTED BYABD alarm and the AutoClamp is configured to CLOSE, the AutoClamp will notautomatically OPEN after Bio-Pump flow is resumed. The user must manuallypress the AutoClamp button on the Main Run Screen to open the clamp aftercareful assurance there will be forward flow.

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

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

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

Battery/UPS

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

When the Uninterruptable Power Supply (UPS) converts the system to batterypower, ALL pumps, pump functions, safety systems, alerts, alarms, monitors,controls, the Pinch Valve and the Central Information Display (CID) are active andfunction 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, andpreparation 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 throughthe local controls for the roller pumps and the Bio-Pump.

If the CID fails during a procedure, the sensors that have safety connections withthe Bio-Pump will remain enabled. The sensors that detect and measure bloodflow, Arterial Line Pressure (ALP), Venous Line Pressure (VLP), VenousSaturation (SvO2), Hematocrit (Hct), Revolutions Per Minute (RPM), andCardioplegia Pressure can be displayed by scrolling through the Liquid CrystalDisplay (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

CompactFlash3memory card. After the CID is changed to the Home Screen,allow a minimum of 10 seconds for the data download to complete beforeremoving the CompactFlashmemory card.

3 CompactFlashis a registered trademark of SanDisk Corporation.


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Using the Pre-Cardiopulmonary Bypass Parameters Screen with thealpha-numeric keyboard during the conduct of cardiopulmonary bypass will coveressential perfusion and cardioplegia delivery information screens. Enter dataprior to initiating bypass. Do not use during bypass.

Tubing

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.

Roller Pump

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

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

The roller pump safety cover interlocks are not enabled until after the RestingHeart 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 ifroller 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, flowdetection and safety systems are inoperable. Closely monitor the circuit to preventintroduction of air.

Bio-Pump

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

If the Bio-Pump stops, immediately clamp the ar terial line and venous line. Checkfor air in the ar terial 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 BYABD alarm, pump flow will remain at 0.5 L/min and will NOT automatically rampup 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 beencompletely removed from the arterial circuit.

Power On Self-Test (POST)

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

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

Air Bubble Detector (ABD)

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


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

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

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

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 iconindicates the sensor is DISABLED and will not generate an alarm if air enters thecardioplegia circuit.

Cautions

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. Restricttouching 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 usewith the Performer CPB, do not use alcohol or alcohol-based fluids. Do not exposeto chemical agents as they may affect the integrity of these devices. Anesthesiasolutions such as FORANE4are known to degrade polycarbonate plastics. Avoidcontact of these solutions with the BPX-80 Bio-Pump.

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

Refer to the instructions included with the MedtronicResting Heart System orspecific 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 thewarranty.

Ensure the castor brakes are engaged before use.

When transporting the machine, reduce the equipments height to the lowestposition to avoid tipping.

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

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

4 FORANE is a registered trademark of ATOFINA.


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2Safety2

Safety Standards 2-2

Disposables and Accessories 2-2

Main Power Supply Failure 2-2

Electromagnetic Disturbance 2-3

Elimination of the Disposable Material 2-3End 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


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Chapter 2Safety Standards

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ATTENTION:The Performer CPB must be operated only by skilled personnel trainedfor this task and in conformity to the present Operators Manual.

Safety Standards

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

The Performer CPB equipment also complies with the following internationalstandards:

Manufacturing safety, electrical safety:

IEC 60513

IEC 60529

EN 60601-1

EN 60601-1-1 (2003)

Functional safety: 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 notbeen validated by Medtronic and will void the warranty on the Instrument and mayjeopardize the functionality of the Instrument, possibly compromising patient safety.

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

Main Power Supply Failure

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


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SafetyElectromagnetic Disturbance


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Electromagnetic Disturbance

The Performer CPB has been designed and tested to comply with the requirementsand 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 fieldsradiated from other equipment in the operating room (ie, defibrillators andelectrocautery devices) that may cause interference.

Special information regarding installation, use, and precautions are described inElectromagnetic Emissions and Immunity Declarations on page 3-6.

The use of any accessory, probes, or cables other than those specified in thisdocument, including replacement parts, may result in either increased emissions ordecreased 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.

End of Life Disposition

Do not dispose of this product in the unsor ted municipal waste stream. Follow localregulations for proper disposal. Please refer to Medtronic web sitehttp://recycling.medtronic.com for proper disposal guidance to ensure compliancewith the European Unions 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 componentlists, 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 internaland external non-restoring fuses.

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

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


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Equipotential Connection

Specific connection for the potential equalization is available on the Performer CPB incase 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 ofequipment 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 thenumber of charge/discharge cycles and on correct use). After this period, batteryreplacement and disposal is provided by authorized, trained personnel.


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3Technical Specifications3

General Data 3-2

Technical Features 3-3

Electromagnetic Emissions and Immunity Declarations 3-6

Monitoring System for Hematocrit, Temperature and O2Saturation 3-10

Temperature Probes 3-11

Battery Supply System (UPS) 3-11

IEC 60601-2-16 Compliance Chart 3-12
http://performer_en_3.pdf/http://performer_en_3.pdf/http://performer_en_3.pdf/http://performer_en_3.pdf/http://performer_en_3.pdf/http://performer_en_3.pdf/


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Chapter 3General Data

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STATEMENT OF CONFORMITY AND CLASSIFICATION

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

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

General Data

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 A

Patient leakage current < 100 A

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)

IP 21: protected against solid foreign objects of12 mm diameter and greater; protected againstdrop water.

Environmental Operating Conditions

Temperature +10C to +40C

Relative humidity 30% to 75% (noncondensing)

Atmospheric pressure 700 to 1060 mBar

Transport and Storage Conditions

Temperature -20C to +60C

Relative humidity 10% to 90% (noncondensing)

Atmospheric pressure 700 to 1060 mBar

Interface

External Motor Dr ive (Bio-Pump) 10-pin LEMO1(EGG.3B.310.CLL)

VARD Sensor 10-pin LEMO(EGG.1B.310.CLL)


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1LEMOis a registered trademark of LEMO USA, Inc.

Technical Features

Flow Probe / ABD 15-pin D-SUB

Level Sensors 7-pin LEMO(EGG.1B.307.CLL)

Auto Clamp 8-pin LEMO(EGG.2B.308.CLL)

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

9-pin D-SUB

Dimensions and Weight

WxDxH 500 x 560 x 1000 - 1400 mm

Weight Approximately 90 kg

Pump PM1 Unidirectional peristaltic pump with manualoperating 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 theencoder.

Open-cover sensor (and subsequent pumpblockage).

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)






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)




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Flows Up to 1.1 L/min (6.4 mm (1/4 in) and6.4 mm (1/4 in) pump segments)

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

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





Pressures (PR1, PR2, PR3, PR4,PR7, PR8)

Electronic measurement by means of sensors

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 andfrom 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 yetimplemented.)

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 7.0L/min

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

Air Bubble Detector (ABD)

Sensitivity Single bubble 0.1 mL (5000 Micron) to 0.3 mL of airat 7.0 L/min flow, 37C, blood


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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 - seepage page 5-44)

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

57800

8

Null

1

Transmission Interval 1 second or greater

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 ASCIIPaper width 111.5 mm

Power supply 24 V DC

Consumption 3.5 A max


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Chapter 3Electromagnetic Emissions and Immunity Declarations

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Electromagnetic Emissions and Immunity Declarations

Emissions Declaration

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

Immunity Declaration

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

Memory Card

Type CompactFlashwith Personal Computer MemoryCard International Association (PCMCIA) adapter

Heater Not yet implemented.

Weighing System Not yet implemented.

Syringe Pump Not yet implemented.

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)

Type Pneumatic

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)

Table 3-1. Electromagnetic Emissions for all Equipment and Systems

(Reference EN60601-1-2)

Emission test Compliance Electromagnetic environment-guidance

RF EmissionsCISPR 11

Group 1 The Performer CPB equipment generatesradio frequency (RF) energy only as abyproduct of its internal function. Therefore,its RF emissions are very low and are notlikely to cause any interference in nearbyelectronic equipment.

RF Emissions

CISPR 11

Class A

HarmonicemissionsIEC 61000-3-2

Class A The Performer CPB equipment is suitablefor use in all establishments other thandomestic and those directly connected tothe public low-voltage power supplynetwork that supplies buildings used fordomestic purposes.

Voltage fluctuation /flicker emissionsIEC 61000-3-3

Complies


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Note: UTis the AC main voltage prior to application of the test level.

Table 3-2. Electromagnetic Immunity for all Equipment and Systems(Reference EN60601-1-2)

Immunity test IEC 60601 Test level Compliance level Electromagneticenvironment-guidance

Electrostaticdischarge(ESD)

IEC 61000-4-2

6 kV contact8 kV in air

Complies to the testlevel

Floor should be wood,concrete, or ceramic tile. Iffloors are covered withsynthetic material, therelative humidity must beat least 30%.

Electrical fasttransient/ burst(ESD)IEC 61000-4-4

2 kV for power supplylines1 kV for input/outputlines


Main power quality mustbe that of a typicalcommercial or hospitalenvironment.

SurgeIEC 61000-4-5

1 kV differential mode2 kV common mode



Voltage dips, shor tinterruption, andvoltage variationson power supplyinput lines

IEC 61000-4-11

95% dip in UT)

for 0.5 cycle

40% UT(60% dip in UT)for 5 cycle

70% UT(30% dip in UT)for 25 cycle

95% dip in UT)for 5 sec



Note: In consideration ofthe possibility ofcontinuous functionaloperation during mainpower interruption, thePerformer CPB equipmentis provided with anUninterruptible PowerSupply (UPS) with battery.

Power frequency(50/60 Hz)magnetic field

IEC 61000-4-8

3 A/m Complies to the testlevel

Power frequency (50/60Hz) magnetic field mustbe at levels characteristicof a typical location in a

typical commercial orhospital environment.


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Table 3-3. Electromagnetic Immunity for Life Supporting Equipment and Systems(Reference EN60601-1-2)

Immunity test IEC 60601 Test level Compliancelevel

Electromagneticenvironment-guidance

Follow the recommendedseparation distance calculatedfrom the equation applicable to thefrequency of the transmitter whenusing portable and mobile RFcommunication equipment inclose proximity to any part of thePerformer CPB equipment,including cables.

Recommended separationdistance

Conducted RF

IEC 61000-4-6

3 Vrms

150 kHz to 80 MHz

Outside ISM bandsa

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

3Vrms d= 1,2 P

10 Vrms

150 kHz to 80 MHz

in ISM bandsa

6Vrms d= 2 P

Radiated RF

IEC 61000-4-3

10 V/m

80 MHz to 2.5 GHz

10 V/m d= 1.2 P 80 MHz to 800 MHzd= 2.3 P 800 MHz to 2.5 GHz

Where P is the maximum outputpower rating of the transmitter inwatts (W) according to thetransmitter manufacturer and d isthe recommended separationdistance in meters (m)b.

Field strengths from fixed RFtransmitters, as determined by anelectromagnetic site surveyc,should be less than the

compliance level in eachfrequency ranged.

Interference may occur in thevicinity of equipment marked withthe following symbol:

b The compliance levels in the ISM frequency bands 150 kHz and 80 MHz and in the frequency range 80MHz 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 additionalfactor of 10/3 is used in calculating the recommended separation distance for transmitters in thesefrequency ranges.

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

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


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

The Performer CPB equipment is intended for use in an electromagnetic environmentin which radiated RF disturbance is controlled. The customer or user of thePerformer CPB equipment can help prevent electromagnetic interference bydistancing the portable and mobile RF communication equipment (transmitters) as faraway as possible from the Performer CPB as recommended in Table 3-4, accordingto the maximum output power of the communication equipment.

c Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones, landmobile radios, amateur radios, AM and FM radio broadcast, and TV broadcast cannot be predictedtheoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, anelectromagnetic site survey should be considered. If the measured field strength in the location in whichthe Performer CPB equipment is used exceeds the applicable RF compliance level above, the PerformerCPB 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.

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

Table 3-4. Recommended separation distance between portable and mobile RFcommunication equipment and the Equipment or System for Life-Supporting Equipment and

Systems (Reference EN60601-1-2)

Rated maximumoutput power of

transmitter

W

Separation distance according to frequency of transmitter

m

150 kHz to 80MHz outside ISMbands

d= 1.2 P

150 kHz to 80MHz in ISMbands

d= 2 P

80 MHz to 800MHz

d= 1.2 P

800 MHz to 2.5GHz

d= 2.3 P

0.01 0.12 0.20 0.12 0.23

0.1 0.38 0.63 0.38 0.73

1 1.2 2 1.2 2.3

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 recommendedseparation distance d in meters (m) can be determined by using the equation applicable tothe frequency of the transmitter, where P is the maximum output power rating of thetransmitter in watt (W) according to the transmitter manufacturer.

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

Note 2:The ISM (Industrial, Scientific and Medical) bands between 150 kHz and 80 MHz are6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283; and 40.66MHz to 40.70 MHz.

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

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


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Chapter 3Monitoring System for Hematocrit, Temperature and O2Saturation

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Monitoring System for Hematocrit, Temperature and O2Saturation

The Performer CPB equipment has an integrated device, called theHematocrit-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

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

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

Warning: The device must be used only with thermistor temperature probes, asindicated 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 orother equipment causing interference (eg, cellular phones).

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

Electrical Data

Voltage 5 VDC

Current 0.2 A

Patient's leakage current < 0.001 mA

Performance

Sat O2operating range 40 to 99%

Sat O2accuracy 4% (with In-Vivo Offset, see page 5-92)

Hct operating range 15 to 50%

O2Sat/Hct


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Temperature Probes

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

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

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

Warning: A periodical maintenance/control of the multiple-use probes detectingefficacy 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, thusallowing treatment to continue.

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

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

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

Temperature Range +2C to +45C

Temperature Accuracy 0.5C

Type Model Re-usable / Disposable

YSI Series 400 Re-usable

High Temperature Do not expose the probe to temperatures higher than100C.

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

Life Prolong the life of the cable by frequently sprinkling it withtalcum powder, especially after disinfection.

Mechanic Stresses Ensure that the cable is not subject to excessivemechanical stress like traction, squeezing, or kinking.

Disinfection For proper disinfection of the multiple-use probes, refer tothe instructions supplied by the manufacturer inside thepackaging.


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Recharging of the battery pack is performed by means of a special circuit located inthe base, therefore allowing the battery pack to get completely recharged when theequipment 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 InstallationProcedure

See IFU page 4-2.

2. Syringe Pump Specification N/A; this device is notimplemented at this time.

3. Blood Pump accuracy and

specification; range, pressureaccuracy

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

4. Protective system descriptionof the dialysis fluidcomposition

(51.101) N/A; there is no dialysis fluidprocessing with this device.

5. Protective system descriptionof the dialysis fluidtemperature

(51.102) N/A; there is no dialysis fluidprocessing with this device.

6. Protective system descriptionof the ultra-filtration

(51.103) N/A; there is no ultra-filtrationprocessing system with thisdevice.

7. Protective system description

of the extracorporeal bloodloss to the environment

(51.104.1) N/A; the perfusionist is

continually in view of the deviceduring use.

8. Protective system descriptionof the blood leak

(51.104.2) N/A; the perfusionist iscontinually in view of the deviceduring use.

9. Protective system descriptionof the blood loss due to thecoagulation

(51.104.3) See IFU page 5-90. If thecirculating hematocrit falls below20%, the Protective Systemactivates distinct audible andvisual cues to warn the user. Incase the blood pump stopsduring Perfusion Mode or in casethe blood pump is stoppedinadvertently, after 60 secondsthe Protective System activatesdistinct audible and visualalarms.
http://-/?-http://-/?-


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4Installation4

Installation 4-2

Installation Checklist and Commissioning 4-3


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Installation

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

Installation

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

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

Do not turn on the equipment if any physical anomalies are noticed that couldjeopardize the correct functioning of the equipment. Contact a Medtronic servicetechnician.

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 powersupply system.

Grounding

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

The grounding reliability of the power source must be accomplished inaccordance with the effective local regulation and the IEC 60601-1 harmonizedstandard (Clauses 18, 58: Protective earthing, functional earthing and potentialequalization).

The hospital/clinics electrical environment department should be contacted forany clarification or questions.

Potential Equalization Line

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

Power Supply

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

Liquid/Foreign Matter Penetration

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

Turning On

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.

Voltage AC 100/240

Frequency 50/60 Hz


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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

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 O2Sat / 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


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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


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5Instructions for Use5

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 5-41Timers 5-46

Cardioplegia 5-49

AAR Controller - Venous Air Removal Device (Resting Heart modeonly) 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


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Chapter 5Console

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Console

External Operational Controls

Figure 5-1. Performer CPB Controls

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

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

3. Grounding Equalization Post:When local regulations require potential

compensation, connect a cable from the potential compensation network to thisgrounding equalization post.

4. Main Power Switch:Press the top of the Main Power switch to turn the systemon. The displays next to the pump controls will illuminate and an audible start-uptone 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 elevatethe console on its pedestal to the maximum up limit. Press and release theDown 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 andreleasing 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 disabledafter leaving the Home Screen and entering an operational mode (Resting Heart orBio-Pump CPB). To adjust the height while in an operational mode, the user mustpress and hold the respective Up or Down switch until the desired height is reached.

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 frontcastors swivel 360 degrees. Press the Castor Brake switch to prevent theconsole from rolling. Press the Castor Unbrake switch to release the brakes andenable movement of the console.

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

Front Panel - Controls and Displays

Figure 5-2. Console Front Panel

1. CID(Closed): Incorporates graphic menus and buttons for the user-selectableoptions, provides enabling or disabling of components and safety devices,

provides visual and audible signals during alert and alarm conditions, monitorssystem functions during use, and displays information pertinent to patientphysiology during extracorporeal procedures.

2. Bio-Pump Control Panel with Backup Displays:Incorporates a pump speedRPM 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/Stopbutton to enable/disable the pump motor, a 3-turn potentiometer knob to controlRPM, 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. Maximumflow 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 thePerformer CPB to a perfusion data collection system.

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


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 toenable/disable the pump motor, a 3-turn potentiometer knob to control RPM, anLCD display to indicate motor on/off status, pump flow, or RPM information, andpump identification information.

8. Small Roller Pump PM3:Configured to be used either as a cardioplegia slavepump in conjunction with PM4, or as a free pump (examples: hemoconcentrator,aortic root vent). Maximum flow capacity is 0.6 L/min. Accommodates thefollowing 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, anLCD to indicate motor on/off status, pump flow, or RPM information, and pumpidentification information.

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

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


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 toenable/disable the pump motor, a 3-turn potentiometer knob to control RPM, anLCD to indicate motor on/off status, pump flow, or RPM information, and pumpidentification information.

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

System Status LEDs (Green, Yellow, and Red)

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

Figure 5-3. System Status LEDs

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

2. When the yellow lights are illuminated, there is either a system status change, asafety 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 isactivated.

Bio-Pump Control Panel

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 toapproximately 4500 RPM.

Completely rotate the knob counterclockwise to below 0 RPM and click toturn the drive motor off.

The knob provides for a minimum RPM detent button. This is a mechanicalstop that prevents an unintentional reduction of RPM below 2000. Press down

on the detent lever while turning the knob counterclockwise to reduce theRPM 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 anadditional display for the Bio-Pump flow value that is also shown on the MainRun 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 tofunction 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 theCID.

Note: In the event the CID fails, the LCDs will continue to function and enableselection and display of the listed parameters. (See Emergency Procedures onpage 7-4.)

4. Scroll Arrows

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The scroll arrows allow selection/viewing of the following parameters in each ofthe 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 rollerpasses through the pump raceway, it occludes the tube and displaces the fluid in thetube 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 myocardialpreservation solutions, and extraction of fluids from the thorax or vascular chambers.

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

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

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Roller Insert

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 centerof 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


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 thealignment pin finds the groove in the motor drive shaft.

5. Slide the roller insert out to remove.

Setting the Roller Pump Speed1. A flashing digital display indicates the pump Start/Stop button is in the Stop

Mode. Turn the roller speed control knob completely counterclockwise. Ensurethat the digital display is flashing 0.

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

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

4. As the pump speed changes, the digital display will reflect the parameter ofeither the pump RPM or the flow rate in milliliters per minute (mL/min) or litersper 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 rotatedcompletely counterclockwise and the digital display is flashing 0.

7. To change the pump label, refer to the System Configuration section onpage 5-16.

Manual Operation with the Integrated Handcrank

Warning: If handcrank operation is necessary due to the loss of AC and batterypower, flow detection and safety systems are inoperable. Closely monitor the circuitto 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, therotation 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.

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

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


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Tube Inserts

Installing the Tube Inserts

To install the tube inserts:


2. Remove the faceplate thumbscrew.

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


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

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

dovetail joint.

6. Replace the faceplate thumbscrew and close the cover.


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Tubing

Loading the Tubing

To load the tubing:

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

Warning: Always ensure proper direction of rotation before installing tubing into theroller pump and that the direction of forward flow for the tubing is consistent with therotational direction of the roller pump. Always ensure that the direction of flow is NOTin 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 tooptimize space in the pump raceway to accommodate the tubing.

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


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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 pumpraceway while rotating the roller insert by hand.

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

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


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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 thelength of the tubing to place in the pump raceway.

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

5. Secure the tubing in the tube insert at the pump outlet. Close the insert, but donot 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 onthe console graphic corresponds with the roller pump that is being loaded withtubing.

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 loadthe tubing into the pump raceway. When the tubing is loaded, release the pumpStart/Stop button to stop the roller pump from turning.

Note: The Tube Loading button will only stay active for 10 seconds each time it ispressed. The top line of the message bar will display LOADING/UNLOADINGPM1 PUMP SEGMENT.

10. Press the tube insert at the pump outlet into the chann