Manual de Manejo Performer

PERFORMER™ CPB
c
PERFORMER™ CPB
An Advanced Extracorporeal Circulatory Support System
Operator’s Manual
c
Distributed Exclusively Manufactured by
by Medtronic, Inc. RanD S.r.l.
Medolla (MO) Italy
PerformerV1.5_EN_SYM.fm 3/4/08 3:02 pm Medtronic Confidential
8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Explanation of symbols on package labeling
Refer to the package label to see which symbols apply to this product
Conformité Européenne (European Conformity). This symbol means that the device fully
0123
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
Maximum Weight
MAX
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
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Bio-Pump
Flowmeter/ABD
Class II (Double Insulated) Equipment
Open Here
Warning, Crushing Hazard: Finger
Pneumatic Pressure Range
Atmospheric Limitation
ii Operator’s Manual
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
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 2-3
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 O2 Saturation 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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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
A Index A-1
iv Operator’s Manual
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PERFORMER™ CPB 0
Operator’s Manual
A14113002 Rev. 2.0

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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
A14113002 Rev. 2.0

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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Introduction
1
1
System Description 1-2
System Overview 1-2
Indications for Use 1-5
Warnings 1-5
Cautions 1-9
Operator’s Manual 1-1
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Chapter 1
System Description
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® Bio-Pump® Centrifugal
Blood Pump, hereafter referred to as the Bio-Pump.
System Overview
Total extracorporeal support of the cardiovascular system is accomplished by using

the Bio-Pump® Centrifugal Blood Pump. The Bio-Pump is the exclusive device on the
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.
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:
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.
1-2 Operator’s Manual
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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.
1 YSI™ is a registered trademark of YSI Incorporated.

2 Transonic™ is a registered trademark of Transonic Systems Inc. Corporation.
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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.
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Introduction
Indications for Use
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® Centrifugal Blood Pump is indicated for use in pumping blood through
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
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
Performer 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.
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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
■ 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.
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 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.
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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.
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®3 memory card. After the CID is changed to the Home Screen,
allow a minimum of 10 seconds for the data download to complete before
removing the CompactFlash® memory card.
3 CompactFlash® is a registered trademark of SanDisk Corporation.
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 1
Warnings
■ 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
■ 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 Resting
Heart™ Screen is opened. Ensure that the roller pump safety covers remain
closed during the Power On Self-Test (POST).
Heart™ Screen is opened. Ensure that the roller pump safety covers remain
closed when in the Emergency Mode.
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.
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
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.
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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.
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. 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 FORANE4 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.
4 FORANE® is a registered trademark of ATOFINA.
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 1
Cautions
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Safety
2
2
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
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
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:
■ 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 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).
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Safety
Electromagnetic Disturbance
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.
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).
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
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.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Technical Specifications
3
3
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
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
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.
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 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 21: protected against solid foreign objects of
(IP code as for IEC 60529) 12 mm diameter and greater; protected against
drop water.
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
Relative humidity 10% to 90% (noncondensing)
Atmospheric pressure 700 to 1060 mBar
Interface
External Motor Drive (Bio-Pump) 10-pin LEMO®1 (EGG.3B.310.CLL)
VARD Sensor 10-pin LEMO® (EGG.1B.310.CLL)
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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 9-pin D-SUB
(5 KV opto-isolated)
Dimensions and Weight

WxDxH 500 x 560 x 1000 - 1400 mm
Weight Approximately 90 kg
1 LEMO® is a registered trademark of LEMO USA, Inc.
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).

operating system
■ Up to 1.5 L/min (6.4 mm (1/4 in) and
encoder.
blockage).

operating system
■ Up to 0.16 L/min (3.2 mm (1/8 in) pump
segment)
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 3
Technical Features

encoder.
blockage).

operating system
Flows ■ Up to 1.1 L/min (6.4 mm (1/4 in) and
■ Up to 0.7 L/min (6.4 mm (1/4 in) and 3.2 mm (1/8
in) pump segments)
encoder.
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
A14113002 Rev. 2.0

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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 6A
Autonomy Minimum 30 min. (with fully loaded system - see
page 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 57800
Bits Number 8
Parity Null
Stop Bit 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 ASCII
Paper width 111.5 mm
Power supply 24 V DC
Consumption 3.5 A max
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 3
Electromagnetic Emissions and Immunity Declarations
Memory Card
Type CompactFlash® with Personal Computer Memory
Card 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)
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.
Table 3-1. Electromagnetic Emissions for all Equipment and Systems
(Reference EN60601-1-2)
Emission test Compliance Electromagnetic environment-guidance
RF Emissions Group 1 The Performer CPB equipment generates
CISPR 11 radio frequency (RF) energy only as a
byproduct of its internal function. Therefore,
RF Emissions Class A its RF emissions are very low and are not
CISPR 11 likely to cause any interference in nearby
electronic equipment.
Harmonic Class A The Performer CPB equipment is suitable
emissions for use in all establishments other than
IEC 61000-3-2 domestic and those directly connected to
the public low-voltage power supply
Voltage fluctuation / Complies network that supplies buildings used for
flicker emissions domestic purposes.
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.
A14113002 Rev. 2.0

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Table 3-2. Electromagnetic Immunity for all Equipment and Systems

Immunity test IEC 60601 Test level Compliance level Electromagnetic
environment-guidance
Electrostatic ±6 kV contact Complies to the test Floor should be wood,
discharge ±8 kV in air level concrete, or ceramic tile. If
(ESD) floors are covered with
IEC 61000-4-2 synthetic material, the
relative humidity must be
at least 30%.
Electrical fast ±2 kV for power supply Complies to the test Main power quality must
transient/ burst lines level be that of a typical
(ESD) ±1 kV for input/output commercial or hospital
IEC 61000-4-4 lines environment.
Surge ±1 kV differential mode Complies to the test Main power quality must
IEC 61000-4-5 ±2 kV common mode level be that of a typical
commercial or hospital
environment.
Voltage dips, short <5% UT Complies to the test Main power quality must
interruption, and (>95% dip in UT) level be that of a typical
voltage variations for 0.5 cycle commercial or hospital
on power supply 40% UT environment.
input lines (60% dip in UT) Note: In consideration of
IEC 61000-4-11 for 5 cycle the possibility of
70% UT continuous functional
(30% dip in UT) operation during main
for 25 cycle power interruption, the
<5% UT Performer CPB equipment
(>95% dip in UT) is provided with an
for 5 sec Uninterruptible Power
Supply (UPS) with battery.
Power frequency 3 A/m Complies to the test Power frequency (50/60
(50/60 Hz) level Hz) magnetic field must
magnetic field be at levels characteristic
IEC 61000-4-8 of a typical location in a
typical commercial or
hospital environment.
Note: UT is the AC main voltage prior to application of the test level.
A14113002 Rev. 2.0

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Chapter 3
Table 3-3. Electromagnetic Immunity for Life Supporting Equipment and Systems
Immunity test IEC 60601 Test level Compliance Electromagnetic
level 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 3 Vrms 3Vrms d= 1,2√ P
IEC 61000-4-6 150 kHz to 80 MHz
Outside ISM bandsa
10 Vrms 6Vrms d= 2√ P
150 kHz to 80 MHz
in ISM bandsa
Radiated RF 10 V/m 10 V/m d= 1.2√ P 80 MHz to 800 MHz
IEC 61000-4-3 80 MHz to 2.5 GHz 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)b.
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site surveyc,
should be less than the
compliance level in each
frequency ranged.
Interference may occur in the
vicinity of equipment marked with
the following symbol:
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.
a 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.
b 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.
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c 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.
d 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.
Table 3-4. Recommended separation distance between portable and mobile RF
communication equipment and the Equipment or System for Life-Supporting Equipment and
Systems (Reference EN60601-1-2)
Rated maximum Separation distance according to frequency of transmitter
output power of m
transmitter
W 150 kHz to 80 150 kHz to 80 80 MHz to 800 800 MHz to 2.5
MHz outside ISM MHz in ISM MHz GHz
bands bands d= 1.2√ P d= 2.3√ P
d= 1.2√ P d= 2√ 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 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.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 3
Monitoring System for Hematocrit, Temperature and O2 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 VDC
Current 0.2 A
Patient's leakage current < 0.001 mA
Performance
Sat O2 operating range 40 to 99%
Sat O2 accuracy ± 4% (with In-Vivo Offset, see page 5-92)
Hct operating range 15 to 50%
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Temperature Probes
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:
High Temperature ■ 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.
Life Prolong the life of the cable by frequently sprinkling it with

talcum powder, especially after disinfection.
Mechanic Stresses Ensure that the cable is not subject to excessive

mechanical stress like traction, squeezing, or kinking.
Disinfection For proper disinfection of the multiple-use probes, refer to

the instructions supplied by the manufacturer inside the
packaging.
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,
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.)
A14113002 Rev. 2.0

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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.
REQUIREMENT REFERENCE RESULT-REMARK
1. Description of the Installation See IFU page 4-2.

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

implemented at this time.
3. Blood Pump accuracy and See IFU page 3-3 to page 3-4.
specification; range, pressure
accuracy
4. Protective system description (51.101) N/A; there is no dialysis fluid

of the dialysis fluid processing with this device.
composition
5. Protective system description (51.102) N/A; there is no dialysis fluid

of the dialysis fluid processing with this device.
temperature
6. Protective system description (51.103) N/A; there is no ultra-filtration

of the ultra-filtration processing system with this
device.
7. Protective system description (51.104.1) N/A; the perfusionist is

of the extracorporeal blood continually in view of the device
loss to the environment during use.
8. Protective system description (51.104.2) N/A; the perfusionist is

of the blood leak continually in view of the device
during use.
9. Protective system description (51.104.3) See IFU page 5-90. If the

of the blood loss due to the circulating hematocrit falls below
coagulation 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.
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10. Protective system description (51.105) See IFU page 5-84. When the
of the Arterial Pressure 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.
11. Protective system description (51.106) For the system description, see
and sensitivity of the Air IFU page 5-63. For the system
Infusion prevention 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.
12. Protective system description (51.111) N/A; there is no Buffer-free HDF

of the Buffer-free HDF preparation with this device.
13. Over-ride time of the (51.108) See IFU page 7-2. An over-ride
Protective System 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
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.
15. Sound pressure level of (51.107) See IFU page 5-30. Except for
audible alarm source. the VARD Alarm, the sound level
(volume) for alarms is not
settable.
16. Contact material with dialysis (51.107) N/A; there is no dialysis fluid
fluid processing with this device.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 3
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Installation
4
4
Installation 4-2
Installation Checklist and Commissioning 4-3
A14113002 Rev. 2.0

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Chapter 4
Installation
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.
■ Voltage 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.
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.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Installation
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
■ 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
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 4
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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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Instructions for Use

5
5
Console 5-2
Roller Pump, Roller Inserts, Tube Inserts, and Tubing 5-6
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
Venous Saturation and Hematocrit Monitoring 5-90
Servo (Resting Heart mode only) 5-104
Preparing for Cardiopulmonary Bypass Checklist 5-109
Initiating Extracorporeal Support Checklist 5-112
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 5
Console
Console
External Operational Controls
3
2
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.
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.
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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
2
6
3 7
4
10
5 11
12
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.
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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:
(Two tubes)
(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)
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)
(Two tubes)
■ 9.5 mm (3/8 in) x 2.4 mm (3/32 in) (PVC)
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.
1
3
Figure 5-3. System Status LEDs
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Console
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
4
3
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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Chapter 5
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 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 4 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
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Roller Insert
1
2
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

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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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 5
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.
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.
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017

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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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 5
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.
6. Replace the faceplate thumbscrew and close the cover.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017

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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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 5
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.
8. Latch the handcrank into the locking channel of the motor drive shaft.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017

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.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 5
Connections for Peripheral Components
6
9
3 10
11
1
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
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.
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.
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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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.
3 2
1
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® memory cards.
The slot to install the CompactFlash® memory card is next to the printer.
Note: Before installing the card and adapter into the Performer CPB, ensure the
system power is off.
1. To insert the CompactFlash® memory card into the PCMCIA adapter, orient the
CompactFlash® memory card so that the slot/groove on the edge of the card
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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Chapter 5
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® memory card. The red LED next to the PCMCIA slot also indicates
data download. DO NOT remove the PCMCIA adapter until the hourglass has cleared
and the red LED goes off.
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).
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).
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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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Chapter 5
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
Figure 5-10. Configuration Mode Password Protection

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.
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5
1
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.
Menu Bar
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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Chapter 5
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:

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

2. Use the left/right scroll arrows to select the temperature channel to be
configured.
■ 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.
Table 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 NO NO NO NO

ONLY RESPONSE RESPONSE RESPONSE RESPONSE
Too Much Air COAST NO NO NO NO

in VARD RESPONSE RESPONSE RESPONSE RESPONSE
Overpressure MESSAGE NO NO NO NO
Alert: VLP ONLY RESPONSE RESPONSE RESPONSE RESPONSE
Overpressure COAST NO NO NO NO
Alarm: VLP RESPONSE RESPONSE RESPONSE RESPONSE
Alert: VARD ONLY RESPONSE RESPONSE RESPONSE RESPONSE
Alarm: VARD ONLY RESPONSE RESPONSE RESPONSE RESPONSE
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Chapter 5
Table 5-2. Default Pump Responses specific to Bio-Pump CPB Mode
Low Blood COAST NO NO NO NO

Level Alert RESPONSE RESPONSE RESPONSE RESPONSE
Low Blood STOP NO NO NO NO

Level Alarm RESPONSE RESPONSE RESPONSE RESPONSE
Alert: PR5 RESPONSE RESPONSE RESPONSE RESPONSE
Alarm: PR5 RESPONSE RESPONSE RESPONSE RESPONSE
Alert: PR7 RESPONSE RESPONSE RESPONSE RESPONSE
Table 5-3. Default Pump Responses Common to both Resting Heart and Bio-Pump CPB
Modes
Air Detected STOP STOP STOP STOP STOP

by ABD
Air in NO STOP STOP STOP STOP

Cardioplegia RESPONSE
Circuit
Bio-Pump NO STOP STOP STOP STOP

Stop RESPONSE
Bio-Pump NO STOP STOP STOP STOP

Coast RESPONSE
Bio-Pump MESSAGE NO NO NO NO
Backflow ONLY RESPONSE RESPONSE RESPONSE RESPONSE
Low Flow ONLY RESPONSE RESPONSE RESPONSE RESPONSE
High Flow ONLY RESPONSE RESPONSE RESPONSE RESPONSE
Alert: ALP ONLY RESPONSE RESPONSE RESPONSE RESPONSE
Overpressure COAST NO NO NO NO
Alarm: ALP RESPONSE RESPONSE RESPONSE RESPONSE
Overpressure NO MESSAGE NO NO NO
Alert: PR1 RESPONSE ONLY RESPONSE RESPONSE RESPONSE
Overpressure NO PAUSE NO NO NO
Alarm:PR1 RESPONSE RESPONSE RESPONSE RESPONSE
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Overpressure NO NO MESSAGE NO NO
Alert: PR2 RESPONSE RESPONSE ONLY RESPONSE RESPONSE
Overpressure NO NO PAUSE NO NO
Overpressure NO NO NO MESSAGE NO
Alert: PR3 RESPONSE RESPONSE RESPONSE ONLY RESPONSE
Overpressure NO NO NO PAUSE NO
Overpressure NO NO NO NO MESSAGE
Alert: PR4 RESPONSE RESPONSE RESPONSE RESPONSE ONLY
Overpressure NO NO NO NO PAUSE
Alert: PR8 ONLY RESPONSE RESPONSE RESPONSE RESPONSE
Alarm: PR8 ONLY RESPONSE RESPONSE RESPONSE RESPONSE
Pump Cover NO PAUSE NO NO NO

Open: PM1 RESPONSE RESPONSE RESPONSE RESPONSE
Pump Cover NO NO PAUSE NO NO

Pump Cover NO NO NO PAUSE NO

Pump Cover NO NO NO NO PAUSE

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.
Table 5-4. Default AutoClamp Responses
The AutoClamp configuration options Default System Configuration Settings

apply only to the following Safety System
events:
BIO-PUMP STOP NO RESPONSE
BIO-PUMP COAST NO RESPONSE
BIO-PUMP LOW FLOW NO RESPONSE
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Chapter 5
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.
5
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.
Table 5-5. Configurable Safety System Events
Event Description USED IN USED IN

RESTING BIO-PUMP
HEART CPB
AIR DETECTED BY ABD Occurs when the Transonic™ YES YES

(ALARM) arterial flow transducer with air
bubble sensor detects air.
AIR IN CARDIOPLEGIA Occurs when the cardioplegia YES YES

CIRCUIT (ALARM) ultrasonic air/fluid sensor detects air.
AIR IN VARD (ALERT) Occurs when air is detected by the YES NO

upper pair of ultrasonic sensors in
the VARD.
TOO MUCH AIR IN Occurs when air is detected by the YES NO

VARD (ALARM) lower pair of ultrasonic sensors in
the VARD.
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RESTING BIO-PUMP
HEART CPB
LOW BLOOD LEVEL Occurs when fluid in the reservoir NO YES

ALERT drops below the position of the
yellow level sensor.
LOW BLOOD LEVEL Occurs when the fluid in the NO YES

ALARM reservoir drops below the position of
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 Occurs when negative flow is YES YES

(ALERT) detected by the TransonicTM arterial
flow transducer.
BIO-PUMP LOW FLOW Occurs when the arterial flow YES YES
(ALERT) detected by the TransonicTM arterial
flow transducer drops below the low
flow limit selected in the Bio-Pump
Setup Screen and the pump RPM is
greater than 2000.
BIO-PUMP HIGH FLOW Occurs when the Bio-Pump is in the YES YES
(ALERT) Venous Line Pressure Servo Mode
and the pump speed exceeds 125%
of the speed when servo was
engaged.
OVERPRESSURE Occur when the Venous Line YES NO

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

ALERT: ALP Pressure (ALP) limits selected in the
Bio-Pump Setup Screen are
ALARM: ALP Selection” on page 5-84.)
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Chapter 5

RESTING BIO-PUMP
HEART CPB
OVERPRESSURE Occur when the line pressure limits YES YES

ALERT: PR1 selected in the Roller Pump Setup
Screen are exceeded. (See “Roller
OVERPRESSURE Pump Pressure Channel Limit
ALARM: PR1 Settings” on page 5-86.)
OVERPRESSURE
ALERT: PR2
OVERPRESSURE
ALARM: PR2
OVERPRESSURE
ALERT: PR3
OVERPRESSURE
ALARM: PR3
OVERPRESSURE
ALERT: PR4
OVERPRESSURE
ALARM: PR4
OVERPRESSURE Occur when the line pressure limits NO YES

OVERPRESSURE
ALERT: PR7
OVERPRESSURE
ALARM: PR7

PUMP COVER OPEN: Occur when the interlock sensor on YES YES
PM1 the pump cover is lifted off the pump
housing.
PUMP COVER OPEN:
PM2
PUMP COVER OPEN:

PM3
PUMP COVER OPEN:

PM4
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Table 5-6. Bio-Pump and Roller Pump Response Definitions
Response Definition
Stop A Stop response causes the pump speed to go to zero and the motor to enter
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.
Coast (for In the Resting Heart mode, a Coast response causes the Bio-Pump speed to
Bio-Pump reduce to a flow of 0.5 L/min. As the pump speed adjusts to achieve 0.5 L/min,
only) 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.
Pause (for A Pause response causes the roller pump speed to be temporarily reduced to
roller zero. The speed remains at zero until the event is cleared or the safety system
pumps is disabled. The pump will then automatically start and gradually ramp up its
only) speed to the previous/original level.
Message A Message Only response causes a message about the event to appear in the
Only 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 If No Response is selected, then no safety system connection is established
Response 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.
Table 5-7. AutoClamp Response Definitions
Response Definition
CLOSE A CLOSE response causes the solenoid valve in the AutoClamp Interface
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.
NO If NO RESPONSE is selected, then no safety system connection is

RESPONSE established between the AutoClamp and the Bio-Pump event.
Note: These configuration options are only selectable when running the Bio-Pump CPB mode.
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Chapter 5
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
4
1
1. Enter Hospital name.

2. Enter Organization name, if applicable.
3. Enter Notes, if applicable.
4. Scroll right to view the Miscellaneous Screen.
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Miscellaneous
1
2
3 8
6
4
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
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
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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Chapter 5
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:

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
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c. ALERT
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 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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Chapter 5
Date and Time Configuration

1
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
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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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Chapter 5
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.
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.
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.
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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
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 “Power On Self-Test” on page 5-17 for procedure).
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.
1
2
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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Chapter 5
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® Resting Heart® Module. The Resting Heart® Module is a
completely integrated, closed-loop extracorporeal circuit which consists of a
Bio-Pump+® Centrifugal Blood Pump, a Bio-Probe® flow sensor, an AFFINITY® NT
Oxygenator, an AFFINITY® Arterial Filter, and an AFFINITY® Venous Air Removal
Device. All non-silicone blood contact surfaces are prepared with Carmeda®1
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.
should use this bypass circuit. Operation of the bypass circuit requires constant
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
1 Carmeda® is a registered trademark of Carmeda A.B.
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System Start-up
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
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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Chapter 5
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:
■ Air Bubble Detector (ABD)
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System Start-up
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.
■ Arterial AutoClamp (Bio-Pump CPB mode only)
The yellow icon is used to initiate the AutoClamp Self

Test.
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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Chapter 5
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:
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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
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.
4 5 10 3 4 14 5
6 8
13
7 9
3 8 7
9 6
11
2 2
12
1 1
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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Chapter 5
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
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.
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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.
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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
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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
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Chapter 5
Timers
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.
3 1 3 2
Figure 5-18. Perfusion Screen Timers

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
REZERO BUTTON START BUTTON STOP BUTTON
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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 START

BUTTON BUTTON
Clamp Timer
STOP BUTTON REZERO START

BUTTON 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 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
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Chapter 5
Timers
■ 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,
■ 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”
Auxiliary Timer
To start the auxiliary timer, press the green Start button. The following will occur when
the Start button is pressed:
■ 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
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Cardioplegia
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

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.
5
4 6
3 2
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.
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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.
Setup Parameters Delivery Parameters

Run Timers Screen Screen Screen
1 3
2
Figure 5-20. Screen Preview Buttons

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.
Volume Tracking
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.
4
3
2
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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.
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Chapter 5
Cardioplegia
Cardioplegia Volume and Time Tracking
2
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.
3 4 5
Time to Next Dose Time Since Last Dose
3. Time to Next Dose: When this timer reaches 00:00,

■ an audible tone sounds
■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 top line in the message bar displays “NEXT CARDIOPLEGIA DOSE DUE”
Note: The Time Since Last Dose timer continues to run until is pressed.
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Cardioplegia
Cardioplegia Circuit and Delivery Parameters
2 5
1 4
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.
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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.
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.”
Note: Pressing 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).
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
.
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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 or preset time is reached:
■ the cardioplegia pump(s) will automatically stop (Volume and Time Modes
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.
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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.”
■ 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.
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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 resume CPG delivery,
■ 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
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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).
2 3
4
5 1
6 7 8
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.
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3. The red “Too Much Air In VARD” read-only icon appears when the fluid level
drops below the second (lower) pair of sensors and:
■ a distinct audible alarm tone will sound
■ the top line of the message bar will display
“TOO MUCH AIR IN VARD: CHECK VACUUM”
■ Bio-Pump flow reduction may be required until venous air is reduced or
eliminated
Note: The Bio-Pump flow can be reduced manually or configured to occur
automatically by setting the Bio-Pump response to Coast.
■ The pinch valve will open, allowing wall vacuum to suction air out of the VARD
until no remaining air/blood mixture is detected by the lower pair of ultrasonic
sensors.
■ the red “TOO MUCH AIR IN VARD” icon will change to the yellow “AIR IN
VARD” icon
■ the red message bar will clear
■ “TOO MUCH AIR IN VARD: CHECK VACUUM” in the top line of the message
bar will change to “AIR IN VARD”
■ the system status LED will change from red to yellow concurrent with the
audible alert tone
■ As wall vacuum suctions the remaining air out of the VARD until the 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.
4. The Fluid-In-Line (FIL) Sensor read-only icon:
■ Displays when air or fluid is being detected by the ultrasonic sensor
downstream from the mechanical pinch valve.
■ In the event excess fluid is being detected by the ultrasonic sensor, the AAR
Controller software closes the mechanical pinch valve.
5. The Wall Vacuum Alert read-only icon:
■ Displays the wall vacuum pressure when a vacuum pressure sensor line is
connected to the pressure luer port labeled PR7 on the Performer CPB
console.
■ The icon will change between gray and red at a default threshold pressure of
-200 mm Hg detected at PR7.
■ When the suction is more negative than -200 mm Hg, the icon will be gray.
■ When the suction is less negative than -200 mm Hg, the icon will change to
red, indicating a low suction alert, accompanied by a distinct audible alert
tone, the system status LED changing to yellow, and the top line of the
message bar displaying “VARD: LOW SUCTION.”
■ All alert indications reset automatically when the PR7 pressure becomes
more negative than -200 mm Hg.
Note: The wall vacuum alert icon is the default display for any pressure
monitoring line connected to PR7.
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Chapter 5
6. The Pinch Valve button:

■ The resting position of the mechanical pinch valve is closed as indicated by
the green Pinch Valve button.
■ When the green [closed] Pinch Valve button is manually pressed, the
mechanical pinch valve opens for 0.5 second. The Pinch Valve button briefly
changes to red [open], then automatically reverts back to green [closed].
■ Displays when the AAR Controller automatically opens and closes the pinch
valve.
Note: Manually pressing the Pinch Valve button overrides the FIL sensor from
detecting fluid in the suction line and from closing the pinch valve.
7. The AAR Controller Mode button indicates the status of the automatic air
removal function of the AAR Controller.
When in Standby Mode, the system will:
■ detect air in the VARD
■ provide concurrent visual and audible alert or alarm cues
■ NOT command the pinch valve to open and remove air from the VARD
If air is detected in the VARD, manually press the Pinch Valve button to
■
remove the air. The pinch valve will open for 0.5 second and then close.
Repeat as necessary to clear the air from the VARD.
8. The AAR Controller Mode button indicates the status of the automatic air
removal function of the AAR Controller.
When in Auto Mode, the system will:
■ detect air in the VARD
■ provide concurrent visual and audible alert or alarm cues
■ command the pinch valve to open automatically to evacuate the air in the
VARD
■ After the air in the VARD is removed and the upper pair of sensors detect
fluid, the system will command the pinch valve to close automatically.
Operation
Warning: Do not operate the AAR Controller with equipment 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
component with the Medtronic® AAR Controller. Any substitution of components
becomes the responsibility of the user. Such substitution will void Medtronic warranty
and the user will bear full responsibility for any adverse consequences stemming from
such use.
1. Attach the metal LEMO® connector on the VARD sensor cable to the console.
Line up the small red dot on the sensor cable connector with the small red
square on the console receptacle. Insert the connector until it “clicks” into place.
To remove the cable, grasp the metal collar and pull straight out. Do not pull with
the cable itself.
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2. Attach the plastic LEMO® connector on the VARD sensor cable to the VARD.
Line up the arrows on the plastic connector with the raised ridge on the VARD
receptacle. Insert the connector until it “clicks” into place.
3. Once the VARD cable is connected and the AAR Controller detects properly
functioning ultrasonic sensors in the VARD, the alert “VARD CABLE NOT
CONNECTED” will clear from the top line of the message bar.
4. To remove the cable, grasp the plastic collar (but do not squeeze the collar) and
pull straight out. Do not pull with the cable itself.
Warning: Do not kink the VARD sensor cable.
Warning: Do not allow fluids to come into contact with the cable connections.
5. Ensure the VARD is primed.
6. Secure the female luer connector on the pressure line to the PR7 pressure
connector on the console.
Warning: Do not bypass the fluid isolator/filter in the pressure line for the PR7
pressure connector or fluid could enter the transducer and damage internal
components.
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Chapter 5
7f
7a
6
7e
7. Ensure that the silicone segment of the VARD purge line is properly seated in the
retention clip, pinch valve, and the FIL sensor.
a. Press and hold down the mechanical button on the pinch valve.
b. Slide the silicone tube into the opening and seat fully into the pinch valve.
c. Release the mechanical button. Once the AAR Controller detects tubing in the
pinch valve, the alert “VARD: TUBE NOT INSERTED IN PINCH VALVE” will
clear.
d. Open the tube latch on the FIL sensor.
e. Slide the silicone tube in the opening, then close the latch.
f. Secure the tube in the retention clip above the pinch valve.
8. Connect the 6.4 mm (1/4 in) ID suction tubing between a wall vacuum
regulator and a disposable rigid suction canister. Connect another segment of
the 6.4 mm (1/4 in) ID suction tubing between the suction canister and the VARD
purge line.
9. Ensure that the vacuum pressure is -200 to -210 mm Hg. Once the PR7 vacuum
pressure sensor detects -200 mm Hg, the alert “VARD: LOW SUCTION” clears
from the top line of the message bar. The vacuum pressure read-only icon will
automatically change from to .
Caution: Use a dedicated regulated vacuum source capable of providing 10 L/min of
air flow and -210 mm Hg.
Caution: Vacuum pressures more negative than -315 mm Hg may cause the FIL
sensor to not function properly.
Note: Small amounts of air may remain in the top of the VARD after priming and be
detected by the upper pair of sensors. The top line of the message bar will display
“AIR IN VARD.”
10. Press to manually open the pinch valve . The pinch valve will remain open
for 0.5 second and then automatically close. Wall suction will remove the air from
the VARD through the VARD purge line.
11. Press to enable the Auto Mode . The alert “VARD: STANDBY
MODE” will clear from the top line of the message bar
Note: In order to transition from Standby to Auto Mode,
a. the VARD cable must be connected between the AAR Controller and the VARD
and the alert “VARD CABLE NOT CONNECTED” cleared from the top line of
the message bar
b. the VARD must be thoroughly primed and free of all air and the alert “AIR IN
VARD” cleared from the top line of the message bar
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Air Detection
c. the vacuum pressure detected at PR7 must be more negative than -200 mm
Hg, and the alert “VARD: LOW SUCTION” cleared from the top line of the
message bar
Warning: Do not use the 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.
Air Detection
The Performer CPB accommodates two air bubble detection (ABD) transducers.
1. The ABD transducer for the detection of macro-air in the arterial circuit is
integrated into the flow sensing transducer and attaches to a 9.5 mm (3/8 in) x
2.4 mm (3/32 in) segment of tubing in the arterial circuit. It is recommended that
the arterial ABD be used on every case.
2. The ABD transducer for the detection of macro-air in the cardioplegia circuit is
mounted to the side of the console near the outlet of the cardioplegia pump
(PM4). It accommodates 6.4 mm (1/4 in) x 1.2 mm (1/16 in) tubing.
Setup and Operation of the Arterial Line ABD System

1. Attach the RS232 connector to the console (see Figure 5-25). The alert
“ABD CABLE NOT CONNECTED” will clear from the top line of the
message bar.
Figure 5-25. RS232 Attachment

2. Attach the transducer to a clean and primed segment of the 9.5 mm (3/8 in) ID x
2.4 mm (3/32 in) arterial line (see Figure 5-26). It is recommended that the
transducer be positioned a minimum of 1.2 m (4 ft) from the patient to allow the
air detection system sufficient time to respond before air can reach the patient.
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Chapter 5
Air Detection
Figure 5-26. Arterial Line Attachment

3. Align the arrow on the transducer with the direction of the flow (see Figure 5-26).
4. For accurate bubble detection, position the sensor so the cable is beneath the
tubing.
User Interface Setup
2 4
Resting Heart mode

3
Bio-Pump CPB mode
Figure 5-27. Air Bubble Detection

1. Press the Safety Systems Configuration button from the Main Menu to open
the Safety Systems Edit Screen.
Note: The default Bio-Pump and roller pump responses to the ABD detecting
arterial air are selected in the Configuration Mode. This screen enables the user
to edit these pump responses on a case-by-case basis. When powered off, the
system automatically resets to the default settings established in Configuration.
2. Press the right scroll arrow until the event “AIR DETECTED BY ABD” is
displayed.
3. Confirm or edit the desired response for the Bio-Pump (Stop, Coast, Message)
and the desired response for each roller pump (Stop, Pause, Message, None).
4. Press to return to the Main Menu.
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Air Detection

1. To enable the ABD:
■ Ensure the flow sensor with ABD is properly positioned on the arterial line.
■ Turn the Bio-Pump RPM to generate forward flow and ensure flow is registering
on the Main Run Screen.
■ Press to enable the ABD. The icon will change to and the alert “ABD OFF”
will clear from the top line of the message bar.
Note: If the ABD cable is not connected to the console when the ABD icon is
pressed, the alert “ABD CABLE NOT CONNECTED” will appear in the message
bar.
2. Indicates “AIR DETECTED.” If this occurs during setup, check the connection of
the transducer to the tubing or reposition the transducer to a different segment of
the 9.5 mm (3/8 in) arterial line.
Note: With the ABD properly connected to the console and enabled, verify the
performance of the arterial ABD before use.
Air Bubble Detection
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Chapter 5
Air Detection
1. If air is detected during use,

■ the message bar will turn red and the top line will display “AIR DETECTED
BY ABD”
■ the “Air Detected” icon will appear
■the Bio-Pump RPM will change if the selected pump response is either Stop
or Coast per the Configuration Mode or as selected during setup
2. When the Bio-Pump response is set to Stop or Coast, the Main Run Screen will
display the Bio-Pump RPM control offset indicator.
represents Bio-Pump Coast.
■ the green bar indicates the actual Bio-Pump RPM
■ the red bar indicates the relative position of the Bio-Pump speed RPM knob
■ the bottom line of the message bar displays “BIO-PUMP COAST”
represents Bio-Pump Stop
■ the absence of the green bar indicates the Bio-Pump RPM is zero
■ the red bar indicates the relative position of the Bio-Pump speed RPM knob
■ the bottom line of the message bar will display “BIO-PUMP STOP”
Note: If two or more events occur to create an alert or alarm, “AIR DETECTED BY
ABD” has the highest priority over all other alert, alarm, and servo conditions.
To Resume Cardiopulmonary Bypass:

Warning: Do NOT press as this will immediately disable the ABD and prevent
enabling the ABD until after flow is resumed.
1. Immediately correct the air condition.
2. Press once to temporarily mute the audible alarm tones.
■ the message bar will remain red
■ the system status LED will remain red
■“AIR DETECTED BY ABD” will remain in top line of the message bar
3. indicates the alarm tones are muted. If the air condition is not corrected and
the alarm is not reset within one minute, the alarm tones will resume.
4. Once the air condition is confirmed corrected, press .
■ the red message bar with “AIR DETECTED BY ABD” will clear
■ the red system status LED will clear
■ Confirm that the ABD icon automatically converts to the ABD ENABLED
Mode and the message “ABD OFF” is not displayed in the top line of the
message bar.
■ If necessary, press the ABD icon until the ABD ENABLED icon appears in the
Main Run Screen and “ABD OFF” clears from the top line of the message bar.
Note: If the Bio-Pump is in the Coast Mode, the pump RPM will not automatically
ramp back up after the ABD sensor is turned off or reset. The user must recapture
manual control of the Bio-Pump speed RPM knob and manually resume flow.
5. Recapture manual control of the Bio-Pump speed RPM knob.
■ Rotate the Bio-Pump speed RPM knob counterclockwise. The red bar in the
Bio-Pump control offset indicator will move to the left.
■ Manual control of the Bio-Pump is recaptured when the offset indicator
disappears.
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Level Sensing System (Bio-Pump CPB mode only)
6. Rotate the Bio-Pump speed RPM knob clockwise to resume flow to the patient.
See “Setup and Operation of the Arterial Line ABD System” on page 5-63 for
Cardioplegia ABD system information.
Overview
The Level Sensing system is a safety device for detecting blood and fluid levels in a
reservoir. The Level Sensing System incorporates a pair of color-coded capacitive
sensors that are attached to the outside of the reservoir. One sensor is designated as
an Alert sensor (yellow); the other sensor is designated as the Alarm sensor (red).
Double-sided adhesive tape is used to secure the level sensors to the reservoir
surface. The sensors are connected to the Performer CPB console via a single LEMO
jack. If the fluid in the reservoir level drops below the position of a level sensor, it will
detect the air/fluid level and cause audible and visual cues to be emitted.
In the event the fluid level drops below the Alert sensor, the system will automatically
generate an audible alert tone, the level detect icon changes to yellow, the System
Status LED changes to yellow, and a message appears in the top line of the Message
Bar. A red LED on the alert sensor will also illuminate. In the event the fluid level drops
below the Alarm sensor, the system will automatically generate an audible alarm tone,
the level detect icon changes to red, the System Status LED changes to red, and a
message appears in the top line of a red message bar. A red LED on the alarm sensor
will also illuminate.
The Performer CPB enables the user to link the Level Sensing System to the
Bio-Pump control or to a roller pump control and either slow down or stop the pump
and prevent further reduction of blood volume in the reservoir. This minimizes the
probability of air being transmitted to the patient.
Set-up and Operation of the Level Sensing System

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 will function properly with the particular
reservoir to be used.
Warning: The performance of the level detection system must be verified before each
use.
User Interface Setup

1. Attach the LEMO connector of the Level Sensor Cable to the Console.
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Chapter 5
2. Press the Level Sensor Button on the Main Menu. This will open the screen
to select the number of level sensor to be used. The level sensors set-up box
allows the operator to select using zero, one, or two level sensors.
3 6
4 5
3. The system default is set to “0” level sensors. Once a mode is chosen to use
zero, one, or two sensors, the system will retain that selection after the console is
powered down.
4. Press the box under the “1” to use only a single level sensor. The green check
will appear in the box.
■ The reservoir icon on the Main Run Screen will display one pair of red arrows.
■The button under the green check will display either ALERT or ALARM.
5. Press to select whether the single sensor will be used as an ALERT sensor or an
ALARM sensor.
■ When ALERT is selected, only the yellow ALERT sensor is attached to the
reservoir. When only the alert sensor is used and fluid in the reservoir drops
below the alert sensor and level sensing is ON, a distinctive audible alert tone
sounds, the System Status LED changes to yellow, the status bar on the
reservoir icon turns yellow, and the top line of the Message Bar displays LOW
BLOOD LEVEL.
■When ALARM is selected, only the red ALARM sensor is attached to the
reservoir. When only the alarm sensor is used and fluid in the reservoir drops
below the alarm sensor and level sensing is ON, a distinctive audible alarm
tone sounds, the System Status LED changes to Red, the Message Bar
changes to red, the status bar on the reservoir icon turns red, and the top line
of the Message Bar will display LOW BLOOD LEVEL.
6. Press the box under the “2” to use both the ALERT and the ALARM level
sensors. The green check will appear in the box.
■ The reservoir icon in the Main Run Screen will have two pairs of red arrows.
■ The ALERT (yellow) sensor must be positioned above the ALARM (red)
sensor.
■ If the Alert sensor is incorrectly positioned below the alarm sensor, the Level
Sensor Error Alert (or Alarm, if level sensing is ON) is activated.
7. Press to accept the settings and return to the Main Menu.
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Note: When the box under the “0” is pressed, the green check will move into the box.
The reservoir in the Main Run Screen will have no red arrows. This indicates level
Detection is disabled.
Select Pump Responses

Warning: If the Bio-Pump response for level detection system is configured to not
stop the pump or not reduce pump RPM, constant monitoring is required to reduce
the risk of emptying the reservoir and transmitting gaseous emboli to the patient.
1. Press to confirm or edit the Bio-Pump and roller pump responses to the LOW
BLOOD LEVEL event. A prompt window will open asking “Yes/No” confirmation
to the request to change the safety system setting. Indicate “Yes” by pressing the
green checkmark.
Note: The default Bio-Pump and roller pump responses to low level detection are
selected in the Configuration Mode. This screen enables the user to edit these pump
responses on a case-by-case basis. When powered off, the system automatically
resets to the default settings established in Configuration.
2. Press the right scroll arrow until the ALERT event “LOW BLOOD LEVEL ALERT”
is displayed.
3. Confirm or edit the desired response for the Bio-Pump (Coast, Message, None)
and the desired response for each roller pump (Stop, Pause, Message, None).
4. Press the right scroll arrow until the ALARM event “LOW BLOOD LEVEL
ALARM” is displayed.
5. Confirm or edit the desired response for the Bio-Pump (Stop, Coast, Message,
None) and the desired response for each roller pump (Stop, Pause, Message,
None).
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Chapter 5
Sensor Attachment and Preparation for Level Sensing
1. Verify the wall thickness of the reservoir is within the specifications stated in
Chapter 3.
2. Attach the level sensor(s) to the outside surface of the reservoir on a flat surface.
Ensure the sensor positions are more than 1 cm away from internal structures of
the reservoir.
■ Remove one side of the protective strip on the adhesive tape.
■ Adhere to the reservoir surface at the desired level(s).
■ Remove the outer protective strip.
■ Apply the sensor(s) firmly to the adhesive strip with the cable hanging
downward and the horizontal line of the cross-line “target” at the desired low
level position for alert or alarm.
■ Secure the cable to prevent the sensors from being inadvertently dislodged.
Warning: Do not attach sensors over labels. Ensure the ALERT sensor is placed
above the ALARM sensor.
Warning: Do not place sensors below the minimum operating level recommended by
the reservoir manufacturer.
Warning: Use the horizontal line of the target as a guide for setting the desired low
level position for the alert and alarms sensors. The accuracy of a level sensor to
detect changes in fluid level can occur above or below the line within the diameter of
the “target.”
3. When the sensors detect fluid:
■ The red arrow(s) on the reservoir icon in the Main Run Screen will change to
green .
■The red LED on the top edge of the level sensor illuminates.
4. Press the level sensor button to enable the level sensing system.
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■ The level detection status bar at the top of the button changes to green.
■ The green arrow(s) will clear.
■ The message LEVEL SENSING DISABLED will clear from the top line of the
message bar.
■ The reservoir icon will display a “full” blood level.
Note: With the cable properly connected to the console and the level sensor(s)
properly attached to the reservoir and the level detection system is ON/ENABLED,
verify the performance of the Level Detection system before use. Performance can
also be tested with the Level Detection system OFF by looking at the color of the
arrows on the icon (red or green). This will not trigger an alarm.
Low Level Detection

1. When the level detection system is ON and fluid drops below the yellow sensor,
a LOW BLOOD LEVEL alert occurs.
■ A distinctive audible alert tone sounds.
■ The System Status LED changes to yellow.
■ The top line of the Message Bar displays LOW BLOOD LEVEL.
■ The status bar on the level detection button changes to yellow.
■ The blood in the reservoir icon lowers.
2. When the LOW BLOOD LEVEL alert occurs and the Bio-Pump response is set
to COAST:
■ The Bio-Pump RPM will change to 2000.
■ The bottom line of the Message Bar will display BIOPUMP COAST.
■ The Main Run Screen will display the Bio-Pump RPM Offset Indicator.
■ The green bar represents the actual Bio-Pump RPM. The red bar represents
the relative position of the Bio-Pump speed RPM knob.
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Chapter 5
3. While the Bio-Pump is in the COAST mode during a LOW BLOOD LEVEL alert
and the fluid level in the reservoir returns above the yellow sensor:
■ The alert tones stop.
■ The display LOW BLOOD LEVEL clears from the top line of the Message Bar.
■ The status bar on the level detection button changes to green.
■ The blood in the reservoir icon raises.
■ The Bio-Pump RPMs ramp back up to the speed that the knob is positioned.
■Once the Bio-Pump RPM returns to normal, the display BIOPUMP COAST
clears from the bottom line of the message bar and the Bio-Pump RPM Offset
Indicator clears from the Main Run Screen.
4. When the level detection system is ON and the fluid drops below the red sensor,
A LOW BLOOD LEVEL alarm occurs.
■ A distinctive audible alarm tone sounds.
■ The System Status LED changes to red.
■ The Message Bar changes to red.
■ The top line of the Message Bar will display LOW BLOOD LEVEL.
■ The status bar on the level detection button changes to red.
■ The blood in the reservoir icon lowers.
5. Press to mute the alarm. If the reservoir level does not return above the red
sensor within one minute, the alarm tones will resume.
6. When the LOW BLOOD LEVEL alarm occurs and the Bio-Pump response is set
to COAST:
■ The Bio-Pump RPM will change to 2000.
■ The bottom line of the Message Bar will display BIOPUMP COAST.
■The green bar represents the actual Bio-Pump RPM. The red bar represents
the relative position of the Bio-Pump speed RPM knob.
7. While the Bio-Pump is in the COAST mode during a LOW BLOOD LEVEL alarm
and the fluid level in the reservoir returns above the red sensor:
a. For a two sensor configuration and the fluid level is above the red sensor and
is still below the yellow sensor:
■ The audible alarm tones change to the audible alert tones.
■ System Status LED changes from red to yellow.
■ The red Message Bar clears.
■ The top line of the Message Bar displays LOW BLOOD LEVEL.
■ The status bar on the level detection button changes from red to yellow.
■ The fluid level in the reservoir icon rises.
■ Once the Bio-Pump RPM returns to normal, the display BIOPUMP COAST
clears from the bottom line of the message bar and the Bio-Pump RPM Offset
Indicator clears.
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AutoClamp System (Bio-Pump CPB mode only)
b. For a one sensor “alarm only” configuration and the fluid level is above the red
sensor:
■ The audible alarms tones cease.
■ The System Status LED changes from red to green.
■ The red Message Bar clears.
■ The display LOW BLOOD LEVEL clears from the top line of the Message Bar.
■ The status bar on the level detection button changes from red to green.
■ Once the Bio-Pump RPM returns to normal, the display BIOPUMP COAST
clears from the bottom line of the Message Bar and the Bio-Pump RPM Offset
indicator clears.
8. When the LOW BLOOD LEVEL alarm occurs and the Bio-Pump response is set
to STOP:
■ The Bio-Pump RPM will change to zero.
■ The bottom line of the Message Bar will display BIOPUMP STOP.
■ The absence of the green bar represents the actual Bio-Pump RPM is zero.
The red bar represents the relative position of the Bio-Pump speed RPM
knob.
9. While the Bio-Pump is in the STOP mode during a LOW BLOOD LEVEL alarm
and the fluid level in the reservoir returns above the red sensor, the user must
manually restart the Bio-Pump.
a. Turn the Bio-Pump Control Knob fully counterclockwise to the full “OFF”
position. The Bio-Pump RPM Offset Indicator will clear.
b. Turn the control knob clockwise to increase RPM and resume arterial flow.
c. Closely monitor the level in the venous reservoir.
Overview
The Performer CPB incorporates an optional AutoClamp System to be placed on the
arterial line when using a Centrifugal pump as the arterial pump. When the Bio-Pump
run mode changes (STOP, COAST, LOW FLOW) there exists the potential for blood
to flow retrograde through the arterial line from the aortic cannula into the venous
reservoir. This "backflow" may cause entrainment of air into the arterial line from
around the aortic cannulation site. If unrecognized when forward flow is resumed, air
may be introduced into the aorta. Placing a pneumatically powered tube clamp on the
arterial line serves to prevent retrograde flow and thereby prevent the potential to
entrain air around the aortic cannulation site.
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Chapter 5
The system is comprised of a Remote Tube Clamp, an AutoClamp Interface Module

and an Oxygen-Air Blender. The device utilizes the hospital compressed air source to
operate the AutoClamp System. The Interface Module mounted on the back of the
console houses the gas regulator, pressure sensor and gas switches for applying and
releasing compressed air for opening and closing the Remote Tube Clamp.
Compressed air applied to the Remote Tube Clamp keeps it in the OPEN position.
When the AutoClamp System is configured by the user to CLOSE in response to a
Bio-Pump Event (STOP, COAST, LOW FLOW, BACKFLOW), the Interface Module
releases gas pressure to the Remote Tube Clamp allowing it to close. Once the
Bio-Pump Event has been corrected, a button on the Central Information Display
allows the user to resume the clamp OPEN position.
When the Bio-Pump run mode changes to COAST, the Bio-Pump motor speed
controller automatically reduces the Bio-Pump RPM to 2000. When the user manually
reduces the Bio-Pump speed with the knob, the position of the “detent” is
approximately 2000 RPM. Because of differences in patient arterial pressure, height
differences between the patient and the venous reservoir, and the use of Vacuum
Assisted venous Drainage, there exists the potential for either forward flow or arterial
backflow when the Bio-Pump is at or near 2000 RPM. The Performer CPB includes
the user-selectable option to configure the Remote Tube Clamp to CLOSE in
response to BIO-PUMP COAST to prevent the potential for arterial backflow.
Warning: Prior to selecting the Remote Tube Clamp response 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.
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
DETECTED BY ABD” alarm and the Remote Tube Clamp is configured to CLOSE,
the Remote Tube Clamp 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.
Caution: If the pressurized gas fails, the air hose is disconnected, or the AutoClamp
Interface Module communication cable becomes disconnected, the clamp closes.
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System Set-up
1. Slide the Remote Tube Clamp (RTC) onto the mount adapter and tighten the
set-screw on the adapter.
2. Mount the bracket onto the pole on the Performer CPB.
3. Attach the RTC with mount adapter to the bracket using the pin.
1
2
3
4. Secure the AutoClamp Interface (ACI) Module to the back of the Performer CPB.
5. Connect the compressed air line and the communication cable from the RTC to
the ACI Module.
4
6. Attach the compressed air T-adapter to the air inlet gas fitting of the Oxygen-Air
Blender, between the blender and the water trap.
7. Attach the appropriate gas supply line from the blender T-adapter to the Gas IN
connection on the right side of the ACI Module.
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Chapter 5
8. Connect the communications cable to the ACI Module and the appropriate
LEMO jack on the External Devices Connector Panel.
Note: Ensure that the compressed air pressure is within the specifications in Chapter
3.
User Interface Set-up

1. From the Home Screen, press SYSTEM CONFIGURATION and enter password.
2. Press to enter the User Preferences Screen.
3. Scroll right to MISCELLANEOUS.
4. To enable the AutoClamp, press the box under “1” in the AUTOCLAMP window.
The green check will move to that box to indicate the AutoClamp feature is
enabled.
5. Press to configure the AutoClamp response to Bio-Pump Events.

6. Press the right scroll arrow to view the following events relevant to closing the
AutoClamp.
■ BIOPUMP STOP
■ BIOPUMP COAST
■ BIOPUMP BACKFLOW
■ BIOPUMP LOW FLOW
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Note: The events listed above are the only events the user can configure to have the
AutoClamp close.
7. Press to return to the Home Screen. A window will appear requesting to:
– Save changes
– Save as New Profile
– Exit Without Saving
8. Press SAVE CHANGES. The Home Screen will appear.
9. Press BIO-PUMP CPB to open the operations screen. A yellow icon for the
AutoClamp will appear in the Main Run Screen .
Prepare AutoClamp for Use

The status of the AutoClamp (Self test, ON, OFF) is controlled using buttons on the
Main Run Screen.
Displayed when the operations screen is first opened. The

AutoClamp is OFF and the clamp is OPEN.
Press to initiate the Self Test.
Displayed when the AutoClamp is OFF and the clamp is OPEN.

Press to turn ON the AutoClamp.
Displayed when the AutoClamp is ON and the clamp is OPEN.

Press to turn OFF the AutoClamp.
Displayed when the Arterial AutoClamp has been activated and

the clamp is CLOSED.
Press to turn OFF the AutoClamp and OPEN the Remote Tube
Clamp.
1. Ensure the AutoClamp System gas lines and communication cables are properly
connected between the ACI Module, blender and RTC.
2. Connect the compressed air and oxygen gas lines from the Oxygen-Air Blender
to the appropriate compressed air and oxygen sources. When gas pressure is
applied to the ACI Module, the RTC will automatically open and enable loading of
tubing. Gas pressure keeps the clamp open.
Note: If the gas pressure to the ACI Module is low, the top line of the Message Bar
will display AUTOCLAMP PRESSURE LOW.
3. The AutoClamp button on the Main Run Screen is yellow.
Note: The button remains yellow until (1) the AutoClamp Self Test is initiated or (2)
the Pump Timer is started. If the Pump Timer is started, the button turns Gray + Red
X.
4. Load the RTC with a primed segment of the arterial line tubing that is distal from
the arterial filter. The RTC accommodates 9.5 mm (3/8 in) ID x 2.4 mm (3/32 in)
wall thickness tubing only.
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Chapter 5
a b c
a. Sufficiently loosen the knob to swing the security latch down.

b. Lift the door and insert the tubing, then close the door.
c. Swing the security latch in place and tighten the knob.
Perform AutoClamp Self Test

Warning: The AutoClamp 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.
1. Ensure a primed segment of the arterial line distal from the arterial filter is
properly loaded in the RTC.
2. Ensure the ultrasonic flow sensor is properly attached to the arterial line.
3. Ensure the arterial filter purge line and sampling manifold stopcocks are closed.
4. Ensure sufficient gas pressure is supplied to the ACI Module (refer to the
specifications on page 3-6).
Note: If there is insufficient gas pressure, the top line of the Message Bar will display
AUTOCLAMP PRESSURE LOW and prevent the Self Test from occurring.
5. Turn on the Bio-Pump, set the RPM > 2000 and generate flow.
6. Press on the Main Run Screen to initiate the SELF TEST.
■ The yellow AutoClamp button will flash.
■ The top line of the Message Bar displays AUTOCLAMP SELF TEST
RUNNING.
■ The AutoClamp closes for 5 seconds.
■ The system looks for the flow reading to register 0.00 L/min.
■ If after 5 seconds the flow registers 0.00 L/min, the AutoClamp opens and the
button changes to . The display AUTOCLAMP SELF TEST RUNNING
clears from the top line of the Message Bar. SELF TEST PASSED will be
entered in the Log Screen.
If the flow does not display 0.00 L/min before 5 seconds, the AutoClamp opens and
the display AUTOCLAMP SELF TEST FAILED appears in the top line of the Message
Bar and the Log Screen. The button remains yellow.
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7. The Self Test Fails if:

■ The RTC does not open at the beginning of the test. This is done to check any
problem unrelated to the ACI Module. The top line of the Message bar will
display AUTOCLAMP SELF TEST FAILED. The Events Log will display
AUTOCLAMP NOT OPENED.
■ The RTC does not close. The top line of the Message bar will display
AUTOCLAMP SELF TEST FAILED. The Events Log will display AUTOCLAMP
NOT CLOSED.
■ The Bio-Pump flow is > 0.00 after 5 seconds. The top line of the Message Bar
will display AUTOCLAMP SELF TEST FAILED.
8. If the Self Test fails, the yellow button remains. The Self Test can be repeated.
Ensure a primed segment of the arterial line distal from the arterial filter is
properly positioned in the RTC and the security latch is tightened.
9. When the Self Test passes:
■ The system will enter AUTOCLAMP SELF TEST PASSED into the Log
Screen.
■ The RTC opens and the AutoClamp button turns to .
10. Press to open the Safety System Edit Screen.
Note: The Arterial AutoClamp responses (CLOSE or NONE) are selected in the
Configuration Mode. This screen enables the user to edit these AutoClamp responses
on a case-by-case basis. When powered off, the system automatically resets to the
default settings established in Configuration.
11. Press the right scroll arrow to view the following events:
■ BIOPUMP STOP
■ BIOPUMP COAST
■ BIOPUMP BACKFLOW
■ BIOPUMP LOW FLOW
12. Confirm or edit the desired response for the AutoClamp (CLOSE, NONE) for
these events.
Operation of the AutoClamp System

The Bio-Pump can be configured to AUTOMATICALLY change its speed (STOP or
COAST) in response to safety systems being activated (AIR DETECTED BY ABD,
LOW BLOOD LEVEL, ALP OVERPRESSURE).
The AutoClamp setting can be configured to CLOSE when the Bio-Pump speed
automatically changes to the STOP mode. In doing so, the AutoClamp will also
CLOSE when the Bio-Pump knob is turned fully counterclockwise and manually
turned off.
The AutoClamp setting can be configured to CLOSE when the Bio-Pump speed
automatically changes to the COAST mode. In doing so, the AutoClamp will also
CLOSE when the Bio-Pump speed is manually reduced to 2000 RPM.
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Chapter 5
User-configured Description of AutoClamp Function

Bio-Pump Event
BIOPUMP STOP If the AutoClamp is configured to CLOSE when the Bio-Pump

(AUTOMATIC) automatically stops:
■ RPMs automatically go to zero and the RTC closes.
■ The Bio-Pump RPM Offset Indicator appears.
■ The AutoClamp button on the Main Run Screen changes to red .
■ Audible alarm tones sound.
■ The System Status LED changes to red.
■ The bottom line of the red Message Bar displays AUTOCLAMP
CLOSED BIO-PUMP STOP.
Warning: Resume flow only after careful assurance there is no air in
the arterial circuit.
To Open the AutoClamp and resume flow:
■ Press to mute the Alarm.
■ Correct the condition that caused the BIOPUMP STOP event.
■ Press the Check button .
■ Turn the Bio-Pump RPM fully counterclockwise. The Bio-Pump
RPM Offset Indicator clears.
■ Turn the Bio-Pump RPM > 2200.
■ Press the red AutoClamp button. The button changes to . The
RTC will open and forward flow will resume.
■ The top line of the Message Bar will display AUTOCLAMP OFF.
■ Once flow is stabilized, press the Gray + Red “X” button to enable
the AutoClamp. The display AUTOCLAMP OFF will clear from the
top line of the Message Bar.
■ The System Status LED will change to Green.
BIOPUMP STOP If the AutoClamp is configured to CLOSE to the event BIO-PUMP

(MANUAL) STOP and the Bio-Pump knob is manually turned fully
counterclockwise to the STOP position:
■ The RTC automatically closes.
CLOSED.
■ Turn the Bio-Pump RPM > 2200.
■ Press the red AutoClamp button. The button changes to . The
RTC will open and forward flow will resume.
■ The top line of the Message Bar will display AUTOCLAMP OFF
and the System Status LED will change to yellow.
■ Once flow is stabilized, press the Gray + Red “X” button to enable
the AutoClamp. The display AUTOCLAMP OFF clears from the
top line of the Message Bar and the System Status LED changes
to Green.
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Bio-Pump Event
BIOPUMP COAST When the AutoClamp is configured to CLOSE when the Bio-Pump
(AUTOMATIC) automatically enters the COAST mode:
■ RPMs automatically go to 2000 and the RTC closes.
■ The Bio-Pump RPM Offset Indicator appears.
■ Audible alert tones sound.
■ The System Status LED changes to yellow.
CLOSED BIO-PUMP COAST.
Warning: 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.
When the condition is corrected that caused the BIOPUMP COAST
event:
■ The RPMs automatically ramp back up.
■ When the RPMs reach 2200, the RTC automatically opens.
■ The display AUTOCLAMP CLOSED clears from the bottom line of
the Message Bar.
■ The AutoClamp button automatically changes to .
■ When the RPMs have returned to normal, the Bio-Pump RPM
Offset Indicator clears, the System Status LED changes to green
and the display BIOPUMP COAST clears from the bottom line of
the Message Bar.
BIOPUMP COAST If the AutoClamp is configured to CLOSE to the event BIO-PUMP

(MANUAL) COAST and the Bio-Pump knob is manually turned clockwise to 2000
RPM or below:
CLOSED
■ Turn the Bio-Pump RPM > 2200. The RTC automatically opens.
■ The red AutoClamp button changes to .
the Message Bar.
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Chapter 5
Manual reduction in Bio-Pump speed can result in the RPM’s being too low to
overcome resistance in the arterial line and maintain forward flow. This can result in
a negative, or retrograde flow through the arterial line detected by the ultrasonic
arterial flow sensor. The AutoClamp setting can be configured to CLOSE when the
Bio-Pump speed is manually changed that results in a negative, or retrograde arterial
flow.

Bio-Pump Event
BIOPUMP When the AutoClamp is configured to CLOSE when the ultrasonic

BACKFLOW arterial flow sensor detects backflow:
■ The System Status LED Changes to yellow.
■ The top line of the Message Bar displays BIOPUMP BACKFLOW.
■ The bottom line of the Message Bar displays AUTOCLAMP
CLOSED.
Immediately correct the condition(s) that created the BIOPUMP
BACKFLOW event.
To resume forward flow, turn the Bio-Pump RPM control knob
clockwise. Once the Bio-Pump RPM > 2200:
■ Press the red AutoClamp button. The RTC will immediately open
to resume forward flow.
the Message Bar.
■ The red AutoClamp button changes to gray and the top line of the
Message Bar will display AUTOCLAMP OFF.
■ Press the Gray AutoClamp button to turn the AutoClamp to ON.
The button changes to green and the display AUTOCLAMP OFF
clears from the top line of the Message Bar.
■ The System Status LED changes to green.
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017

Manual reduction in Bio-Pump speed can result in the flow dropping below a
user-defined low flow limit and create a BIOPUMP LOW FLOW event. The AutoClamp
setting can be configured to CLOSE when the Bio-Pump speed is manually changed
that results in the flow reaching the BIOPUMP LOW FLOW limit setting.

Bio-Pump Event
BIOPUMP LOW See page 5-94 to set the Bio-Pump Low Flow Limit. When the
FLOW AutoClamp is configured to CLOSE when the ultrasonic flow sensor
detects the LOW FLOW limit:
■ The System Status LED Changes to yellow.
■ The top line of the Message Bar displays BIOPUMP LOW FLOW.
■ The bottom line of the Message Bar displays AUTOCLAMP
CLOSED.
Immediately correct the condition that caused the BIO-PUMP LOW
FLOW event.
To resume forward flow, turn the Bio-Pump RPM control knob
clockwise. Once the Bio-Pump RPM > 2200:
■ Press the red AutoClamp button. The RTC will immediately open
and enable forward flow.
the Message Bar.
■ The red AutoClamp button changes to gray and the top line of the
Message Bar will display AUTOCLAMP OFF.
■ Press the Gray AutoClamp button to turn the AutoClamp to ON.
The button changes to green and the display AUTOCLAMP OFF
clears from the top line of the Message Bar.
■ The System Status LED changes to green.
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 5
Pressure Mode Selection
The Performer CPB accommodates eight (8) pressure monitoring locations. The
system will measure pressures between -250 mm Hg and +750 mm Hg.
All pressure monitoring transducers are located inside the console. Each transducer
has an external metal male luer connector permanently mounted on the console.
These luer connectors accommodate the attachment of disposable pressure
monitoring sets between the extracorporeal circuit and the pressure monitoring
transducer.
Warning: Only pressure monitoring sets that incorporate an air-fluid pressure isolator
may be used with the Performer CPB pressure monitoring system.
The Performer CPB allows for the input of user-selectable pressure limit values and
input of the pump responses when the pressure limits are reached. Pressure safety
limits with their concomitant pump responses are typically defined as alert limits and
alarm limits. Alert limits typically serve to elevate the user's awareness of changing
line pressure conditions. Alarm limits typically serve to warn the user of high pressure
situations and incorporate an automatic pump response to prevent the high pressure
from creating a catastrophic event.
The factory default alert and alarm pressure limits and the pump responses for the
Resting Heart mode are listed as follows:
PUMP ALERT LIMIT PUMP ALARM PUMP

AFFECTED (mm Hg) RESPONSE LIMIT RESPONSE
(mm Hg)
PR-1 PM1 200 MESSAGE 300 PAUSE
(Cardioplegia)
PR-5 (VLP) BIO-PUMP -100 MESSAGE -200 COAST
PR-6 (ALP) BIO-PUMP 200 MESSAGE 300 COAST
PR-7 (VARD) NONE 200 MESSAGE -500 MESSAGE
PR-8 NONE 200 MESSAGE 300 MESSAGE
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017

The factory default alert and alarm pressure limits and the pump responses for the
Bio-Pump CPB mode are listed as follows:
PUMP ALERT LIMIT PUMP ALARM PUMP

AFFECTED (mm Hg) RESPONSE LIMIT RESPONSE
(mm Hg)
(Cardioplegia)
PR-6 (ALP) BIO-PUMP 200 MESSAGE 300 COAST
Note: The factory default alert and alarm pressure limits can be edited before and
during each case. All edits are saved when the Home button is pressed or the system
is powered off.
Editing Pressure Limits for the Current Case Only
Arterial and Venous Line Pressure Limit Settings
Resting Heart Mode

3
Bio-Pump CPB Mode
Figure 5-30. Arterial and Venous Line Pressure Limit Settings

1. Resting Heart: Press from the Main Menu to display the pressure limits for
the arterial line (ALP) and the venous line (VLP) alert limits (blue) and alarm
limits (red).
2. Bio-Pump CPB: Press from the Main Menu to display the pressure limits for
the arterial line (ALP) alert limits (blue) and alarm limits (red).
3. Press the button displaying the pressure limit to be changed. A Pressure pop-up
window will appear.
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Chapter 5
4. Press the Up/Down arrows until the desired pressure value is displayed. The
system will accept either positive or negative values. Press the edited value to
accept the value. If the new value is not confirmed, the pressure limit will revert
back to the old value and the pop-up window will clear.
Roller Pump Pressure Channel Limit Settings

2 3 6
Figure 5-31. Roller Pump Pressure Channel Limit Settings

1. Press from the Main Menu to display the pressure limits for roller pump
pressure channels (PR1, PR2, PR3 and PR4).
Notes: PR1 is the dedicated pressure channel for roller pump PM1.
PR2 is the dedicated pressure channel for roller pump PM2.
PR3 is the dedicated pressure channel for roller pump PM3.
PR4 is the dedicated pressure channel for PM4 (cardioplegia pump).
2. Press to select the desired roller pump to confirm or edit the pressure limit
settings.
3. Press the button for the pressure limit to be edited. The Pressure pop-up window
will appear.
6. Not yet implemented.
Caution: When the system returns to the Home Screen:
■ Edits to pressure limits are stored in the active User Profile
■ Edits to pump responses (and in general all the Safety Systems settings) are
reset to the values of the active User Profile.
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Zeroing the Pressure Transducers
2 3
Figure 5-32. Pressure Parameters Screen

1. Press to open the Parameters Screens.
2. Use the scroll arrows to select PRESSURES [MMHG].
3. Ensure that the pressure luer ports are open to atmosphere. Press to zero
the transducers. The value in the displays will read 0 mm Hg.
4. Press to close the Parameters Screen and return to the Main Menu.
Alert Limit
The alert limit should be set to warn of slowly changing conditions that may raise the
average pressure significantly, such as a cannula misalignment or increased systemic
resistance. When the pressure exceeds an alert limit:
■ the system status LED illuminates yellow
■ a distinct audible alert tone sounds
■ the top line of the message bar displays the pressure limit that was exceeded
(ALP Overpressure Alert, CPG Overpressure Alert, etc)
■ pump speed(s) may change depending on the factory default pump responses or
changes made during editing
Correct the high pressure condition. When the pressure drops below the alert limit,
the alert indicators will clear automatically.
Start the pump(s) if configured to stop for an alert condition.
Alarm Limit
The alarm limit should be set to warn of either instantaneous high pressure situations
that may rupture a tubing circuit (cardioplegia circuit) or when other line pressures
exceed otherwise normal clinically acceptable limits (restriction in the Bio-Pump
circuit). When the pressure exceeds the user-defined alarm limit:
■ The System Status LED changes to red
■ Distinct audible alarm tones sound
■ The message bar changes to red
■ The top line displays the pressure channel that was exceeded (ALP Overpressure
Alarm, CPG Overpressure Alarm, etc)
■ The appropriate pressure pop-up window will appear
■ Pump speed(s) may change depending on the factory default pump responses,
configuration settings, or changes made during editing.
If the pump response is set to Stop, Coast (Bio-Pump), or Pause (Roller Pump):
■ The pressure will drop below the alarm limit and the alarm indicators will clear
automatically
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 5
■ The pressure pop-up window will remain visible
User Intervention
1. Correct the high pressure condition.
2. If necessary, reset the value for the pressure limit using the pressure pop-up
window and confirm the new pressure limit value.
3. Start the pump(s) if configured to Stop for an alarm condition.
Pressure Monitoring Sets with Air/Fluid Isolators Setup

Warning: 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.
1. Prime the pressure monitoring set. (Instructions for priming are included with the
pressure monitoring set.)
2. Ensure there is no flow going through the circuit and there is no pressure
transmitted to the monitoring set.
3. For monitoring positive pressure circuits (arterial line, cardioplegia), prime the
isolator dome so the diaphragm is displaced towards the extracorporeal circuit;
the dome should be predominantly air-filled. Close the stopcock between the
isolator dome and the circuit.
Figure 5-33. Isolator Dome For Positive Pressure Circuits

4. For monitoring negative pressure circuits (venous line, LV vent), prime the
isolator dome so the diaphragm is displaced away from the circuit; the dome
should be predominantly fluid-filled. Close the stopcock between the isolator
dome and the circuit.
Figure 5-34. Isolator Dome For Negative Pressure Circuits
Note: A diaphragm in the isolator dome that becomes fully deflected away from the
metal luer fitting during use (negative pressure circuits) or fully deflected towards the
metal luer fitting during use (positive pressure circuits) indicates an air leak in the
pressure transducer system. Check to insure the female luer is securely fitted to the
metal luer fitting on the console. If the leak persists, contact a Medtronic service
representative.
5. Ensure the transducers are properly zeroed.
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6. Connect the female luer connector(s) of the pressure monitoring set to the
appropriate transducer luer connector on the console.
7. Open the stopcock between the isolator dome and the circuit.
8. Ensure every pressure monitoring system is functioning properly prior to use.
Pressure Monitoring
The windows on the Main Run Screen for arterial line pressure and the venous line
pressure accommodate displaying the systolic, diastolic, mean, and instantaneous
pressures. Changes can be made during use.
1 1
2 3 4 5
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Chapter 5
Venous Saturation and Hematocrit Monitoring
Figure 5-35. Various Pressure Displays

1. Press to scroll through the arterial values (systolic pressure, mean pressure,
diastolic pressure, and instantaneous pressure). (Note the changes in the sine
wave icon.)
2. Systolic Pressure
3. Mean Pressure
4. Diastolic Pressure
5. Instantaneous Pressure
1. Identify the Saturation/Hematocrit (O2 Sat/Hct) cable with the sensor and the
Hematocrit-Temperature-Saturation (HTS) Module located on the back of the
console.
2. Connect the sensor cable to the HTS Module.
O2 Sat/Hct
3. Snap the sensor to the disposable cuvette in the perfusion circuit.
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4. Detection and display of the hematocrit (Hct) and venous saturation (OXYGEN
SAT) occur automatically and are displayed on the Main Run Screen. No
prebypass calibration or in-vitro recalibration are required.
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.
Set the Low Hematocrit (HEMATOCRIT) Alert
1 1
1. Press the HCT button on the Main Run Screen. The HCT pop-up window will
appear.
2. Press the Up/Down arrows until the desired low HCT alert value is displayed.
3. Press the edited value to accept the value. If the new value is not confirmed, the
low HCT value will revert back to the old value and the pop-up window will clear.
4. If the Hematocrit falls below the alert value, the System Status LED will change
to yellow, an audible alert tone sounds, and the top line of the Message Bar
displays HEMATOCRIT: LOW VALUE.
Set the Low Oxygen Saturation (OXYGEN SAT) Alert

1. Press the OXYGEN SAT button on the Main Run Screen. The OXYGEN SAT
pop-up window will appear.
2. Press the Up/Down arrows until the desired low OXYGEN SAT alert value is
displayed.
low OXYGEN SAT alert will revert back to the old value and the pop-up window
will clear.
4. If the Oxygen Saturation falls below the alert value, the System Status LED will
change to yellow, an audible alert tone sounds, and the top line of the Message
Bar displays OXYGEN SATURATION: LOW VALUE.
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Chapter 5
In-Vivo Offset Adjustment for Venous Saturation and Hematocrit

The SAT/HCT software allows the user to adjust none, one or both of the displayed
values to match values obtained from laboratory analysis.
Note: When the Offset feature is used, the venous blood sample should be drawn
when patient hemodynamics are stable. More than one lab sample should be
considered before making an Offset adjustment. Laboratory analysis should provide
measured values for SAT and HCT.
1. When the blood sample has been taken, press the SAT/HCT Offset Button in
the Main Menu to store the current HCT and OXYGEN SAT values.
Resting Heart mode Bio-Pump CPB mode
2. The SAT/HCT Offset Button changes to two independent Recall buttons and the
Stored icon is added to both the Hematocrit and Oxygen Sat. boxes.
3. If the results from the lab sample warrant adjusting the HCT Offset, press the
HCT Recall button to change the value.
4. A Pop-Up window will appear. Press the appropriate Up/Down buttons to modify
the value to match the lab results.
5. Press the HCT value to confirm the new value. The Confirmation Window will
appear when pressed within 10 seconds of modifying the value.
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6 7
6. Press to cancel the new value. The confirmation window and HCT pop-up
window will disappear.
7. Press to confirm the new value.
10
8. After confirming the new value, the HCT recall button becomes grey and is not
selectable.
9. The Stored icon is deleted indicating the HCT value has been updated.
Note: If the user does not confirm the new value (by pressing the upper box) within
10 seconds as instructed in step 5:
a. The pop-up window disappears.
b. The HCT recall button remains colored and is still selectable.
c. The Stored icon is not deleted. Therefore, no offset has applied to the stored
value.
Repeat steps 3, 4, 5, and 7 to ensure the new (offset) value obtained from the lab
sample is properly entered into the system.
10. If the results from the lab sample warrant adjusting the O2 SAT Offset, press the
O2 SAT Recall button and continue as in steps 4 through 7 to change the value.
11
12
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Chapter 5
Options Menu Screen
11. After both the values (HCT and SAT) have been modified and confirmed, the
SAT/HCT Offset Button replaces the Recall button. The procedure can be
restarted.
12. The Stored icon for SAT is also deleted and the value is updated.
Note: When the system returns to the home screen or is powered down, the SAT and
HCT offset values will be removed.
Options Menu Screen
Bio-Pump
2 Resting Heart Mode

5 7 4
Bio-Pump CPB Mode
Figure 5-36. Bio-Pump Screens

1. Press from the Main Menu to confirm or edit the following:
■ the low flow limit (in L/min)
■ alert and alarm pressure limits for venous line (VLP) (Resting Heart mode
only)
■ alert and alarm pressure limits for the arterial line (ALP)
■Bio-Pump responses (Stop, Coast, Message, None) when the above Safety
Limits are exceeded
2. Press the button displaying the pressure value to be edited (ALP alert or alarm
pressure limits and/or VLP alert or alarm pressure limits). The corresponding
Pressure pop-up window will appear.
4. Press the response button to edit the Bio-Pump response to the VLP alert and
alarm (Resting Heart mode only) and ALP alert and alarm events. The button will
scroll through the options of Stop, Coast, Message, and None.
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Options Menu Screen
5. Press the button displaying the low flow value to edit the value. The
corresponding Low Flow pop-up window will appear.
6. Press the Up/Down arrows until the desired low flow value is displayed. Press
the edited value to accept the value. If the new value is not confirmed, the low
flow value will revert back to the old value and the pop-up window will clear.
7. Edit the Bio-Pump response to either Message Only or Stop.
Note: The default Bio-Pump response is Message Only.
Note: When the Performer CPB is powered off, any edits to low flow or the pressure
limit value will be saved. Edits to pump responses entered in these screens will revert
to the settings stored in the active User Profile established by the System
Administrator in the Configuration Mode.
Roller Pump Setup

The pressure limits, pump responses, tube size setting, and units of measure (L/min,
mL/min, or RPM) of each roller pump can be individually edited to meet the needs for
a specific case.
6
2
7
5
Figure 5-37. Roller Pump Settings

1. Press from the Main Menu to confirm or edit the settings for pressure limits,
pump responses, units of measure (L/min, mL/min, RPM), and tube size for the
roller pumps.
2. The red identifier indicates which roller pump is associated with the parameters
viewed.
Note: The default roller pump reference “PM1” corresponds to the lower-left
pump on the front of the console.
Press to switch the red identifier. Going counterclockwise, the remaining
pumps are referenced as PM2, PM3, and PM4.
3. Scroll through RPM, L/min, and mL/min.
4. Scroll through 6.4 mm (1/4 in), 9.5 mm (3/8 in), or 6.4 mm (1/4 in) and 6.4 mm
(1/4 in) (PM1 and PM2 only).
Note: Only roller pumps PM1 and PM2 include the option to edit the tubing ID in
this screen. The tubing ID for roller pumps PM3 and PM4 are edited using the
Cardioplegia Setup Screens.
5. Press the pressure limit value to be edited. A pop-up window will appear.
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Chapter 5
Options Menu Screen
6. Press the Up/Down arrows to edit the limit value. The system accepts positive or
negative values. Press the edited value to accept the value. If the new value is
not confirmed, the pressure limit will revert back to the old value and the pop-up
window will clear.
7. Edit the pump response to PR1 ALERT and PR1 ALARM. The button will scroll
through the options Stop, Pause, Message, and None.
8. Repeat steps 3 through 7 for pumps PM2, PM3, and PM4.
Note: When the Performer CPB is powered off, any edits to low flow or the pressure
limit value will be saved. Edits to pump responses entered in these screens will revert
to the settings stored in the active User Profile established by the System
Administrator in the Configuration Mode.
Safety System
Pump response to events generated by various devices (air sensors, pressure
sensors, flow sensors, roller pumps, Bio-Pump) can be edited prior to initiation of
cardiopulmonary bypass or during the case.
2 4
Resting Heart mode 3
Bio-Pump CPB mode
Figure 5-38. Safety System Configuration Edit Screens

1. Press to confirm or edit the Bio-Pump and roller pump responses to events.
A prompt window will open asking “Yes/No” confirmation to the request to
change the safety systems settings. Indicate “Yes” by pressing the green
checkmark.
Note: When the Performer CPB is powered off, any edits to low flow or the
pressure limit values will be saved. Edits to pump responses entered in these
screens will revert to the settings stored in the active User Profile established by
the System Administrator in the Configuration Mode.
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Options Menu Screen
2. Scroll through the safety system events to be configured. When the right scroll
arrow is pressed, the events appear in the sequence as shown in Table 5-8.
3. Once an event is selected, confirm the appropriate pump response for the
Bio-Pump and the four roller pumps. Responses to events include Stop, Coast
(Bio-Pump only), Pause (roller pumps only), Message, and None (see
definitions, Table 5-9). To change/edit responses, press the Pump Response
Select button for the Bio-Pump and individual roller pumps.
4. Press to accept the settings and return to the Menu Screen.
Table 5-8. Safety System Events
Event Description Used In Used In

Resting Bio-pump
Heart CPB
AIR DETECTED BY Occurs when the TransonicTM arterial YES YES
ABD (ALARM) flow transducer with air bubble sensor
detects air.
AIR IN Occurs when the cardioplegia ultrasonic YES YES
CARDIOPLEGIA air/fluid sensor detects air.
CIRCUIT (ALARM)
AIR IN VARD Occurs when air is detected by the upper YES NO
(ALERT) pair of ultrasonic sensors in the VARD.
TOO MUCH AIR IN Occurs when air is detected by the lower YES NO
VARD (ALARM) pair of ultrasonic sensors in the VARD.
LOW BLOOD Occurs when fluid in the reservoir drops NO YES
LEVEL ALERT below the position of the yellow level
sensor.
LOW BLOOD Occurs when the fluid in the reservoir NO YES
LEVEL ALARM drops below the position of the red level
sensor.
BIO-PUMP STOP Occurs when the Bio-Pump enters the YES YES
Stop Mode.
BIO-PUMP COAST Occurs when the Bio-Pump enters the YES YES
Coast Mode.
BIO-PUMP Occurs when negative flow is detected by YES YES
BACKFLOW the TransonicTM arterial flow transducer.
(ALERT)
BIO-PUMP LOW Occurs when the arterial flow detected by YES YES
FLOW (ALERT) the TransonicTM arterial flow transducer
drops below the low flow limit selected in
the Bio-Pump Setup Screen and the
pump RPM is greater than 2000.
BIO-PUMP HIGH Occurs when the Bio-Pump is in the YES YES
FLOW (ALERT) Venous Line Pressure Servo Mode and
the pump speed exceeds 125% of the
speed when servo was engaged.
OVERPRESSURE Occur when the Arterial Line Pressure YES YES
ALERT: ALP (ALP) limits selected in the pressure
channel configuration screen for PR6 are
ALARM: ALP Selection” on page 5-84.)
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 5
Options Menu Screen

ALERT: PR1 selected in the pressure channel
configuration screen are exceeded. (See
OVERPRESSURE “Roller Pump Pressure Channel Limit
ALERT: PR2 Settings” on page 5-86.)
OVERPRESSURE
ALARM: PR2
OVERPRESSURE
ALERT:PR3
OVERPRESSURE
ALARM: PR3
OVERPRESSURE
ALERT: PR4
OVERPRESSURE
ALARM: PR4
OVERPRESSURE Occur when the Venous Line Pressure YES NO
ALERT: VLP (VLP) limits selected in the pressure
channel configuration screen for PR5 are
ALARM: VLP Selection” on page 5-84.)
OVERPRESSURE Occur when the line pressure limits NO YES
OVERPRESSURE
ALERT: PR7
OVERPRESSURE
ALARM: PR7
PUMP COVER Occur when the interlock sensor on the YES YES
OPEN: PM1 pump cover is lifted off the pump housing.
PUMP COVER
OPEN: PM2
PUMP COVER
OPEN: PM3
PUMP COVER
OPEN: PM4
Table 5-9. Common Bio-Pump and Roller Pump Response Definitions
Response Definition
Stop A Stop response causes the pump speed to go to zero and the motor to
enter 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 Bio-Pump is in the Servo Mode, the pump will switch
to the Manual Mode after it is restarted.
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Options Menu Screen
Coast (for In Resting Heart mode, a Coast response causes the Bio-Pump speed to
Bio-Pump reduce to a flow of 0.5 L/min. As the pump speed adjusts to achieve 0.5
only) 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.
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.
Pause (for A Pause response causes the roller pump speed to be temporarily
roller pumps reduced to zero. The speed remains at zero until the event is cleared or
only) the safety system is disabled. The pump will then automatically start and
gradually ramp up its speed to the previous/original level.
Message A Message 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.
None If None 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.
Table 5-10. AutoClamp Response Definitions
Response Definition
CLOSE A CLOSE response causes the solenoid valve in the AutoClamp Interface
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.
NO If NO RESPONSE is selected, then no safety system connection is

RESPONSE established between the AutoClamp and the Bio-Pump event.
Note: These configuration options are only selectable when running the Bio-Pump
CPB mode.
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Chapter 5
Options Menu Screen
Patient Information
Note: Entering information into the Patient Information Screens will cause the
alpha-numeric keyboard to appear over the Main Run Screen and the Cardioplegia
Screen. This is the only situation when a secondary screen operation covers the Main
Run Screen and the Cardioplegia Screen.
Warning: 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.
Screen 3?
Figure 5-39. Entering Pre-Cardiopulmonary Bypass Patient Data

1. Press to open the Patient Information Screens.
2. In screen 1, press the appropriate lavender buttons to enter PATIENT ID,
SURGEON, PERFUSIONIST #1, PERFUSIONIST #2, ANESTHESIOLOGIST,
and NOTES. The alpha-numeric keyboard will appear for entry of information.
Use the Up/Down scroll arrows to view lines.
Note: The Parameter button must be pressed to accept entered information.
3. Press to change to screen 2 and enter prebypass patient and perfusion
parameters.
4. Press to change to screen 3 and view calculated pre-cardiopulmonary
bypass parameters.
5. Press to scroll/select the desired BSA formula: BSA (DUBOIS), BSA
(BOYD), or BSA (INFANT).
Pressure, Temperature, Flow Parameters

Simultaneous viewing of all eight pressure channels, all eight temperature channels,
or the flows of the four roller pumps is accessed through the following Main Menu
options.
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017

Options Menu Screen
1. Press to open the secondary screens to view the values being monitored
by the eight pressure channels, the eight temperature channels, or the four roller
pump flows.
2. Press or to scroll and view the channels displaying:
■ Eight temperature channels
■ Flow rates for the 4 roller pumps
■ Eight pressure (mm Hg) channels.
In the PRESSURES (MMHG) screen, each button can be used to confirm or edit the
ALERT pressure limit for that channel.
3. Press the desired pressure channel. A pop-up window will appear for that
channel displaying the ALERT limit.
4. To edit, press the Up/Down arrows until the desired pressure value is displayed.
The system will accept either positive or negative values.
pressure limit will revert back to the old value and the pop-up window will clear.
Trending
2 3
Figure 5-40. Trending Screen
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Chapter 5
Options Menu Screen
1. Press to open the Trending Screens.

2. Scroll through categories Others, Pressures, and Temperatures.
3. Scroll through the parameters for each category (see Table 5-11 for complete list
of parameters).
Note: Pressing at the bottom of the Main Run Screen begins trending.The
trending clock will not start until the Pump Timer button is pressed regardless of
how long the entire system has been running.
4. The X-axis scale represents elapsed time since the “On Pump” start time.
■ The first point of the trend is created after 1 minute, then each minute
thereafter.
■ The beginning of the graph displays the range 00:00 to 01:30.
■ If trending extends beyond 01:30, the range shifts right by 30 minutes.
■ The range always displays 90 minutes.
5. The Y-axis scale contains either a fixed range or begins with an initial range that
is determined by the first value detected (see Table 5-11). This way, the initial
value detected is initially centered on the Y-axis and the minimum and maximum
values are constantly and automatically updated while trending graphs are
created.
Table 5-11. Trending Parameters and Y-Axis Ranges
OTHERS PRESSURES TEMPERATURE

Parameter Y Axis Parameter Y Axis Range Parameter Y Axis
Range* Range
Oxygen 0-300 PR1 to PR4 Initial pressure
Concentration 0-400 reading of + and -
(mL/min)* 0-500 20 mm Hg
100-300
100-400
100-500
Hematocrit 10-30 VLP Initial pressure
(%)* 10-40 reading of + and -
10-50 20 mm Hg
Oxygen 40-100 ALP Initial pressure Initial
Saturation 50-100 reading of + and - temperature
T1 - T8
20 mm Hg reading of
(%)* + and - 2°C
Bio-Pump 0.00-4.00 VARD Initial pressure
Flow 0.00-5.00 reading of
(L/min)* 0.00-6.00 +10 mm Hg to
0.00-7.00 - 30 mm Hg
0.00-8.00
Cardiac Index 0.00-3.00 PR8 Initial pressure
(L/min/M2 0.00-4.00 reading of + and -
BSA)* 1.00-3.00 20 mm Hg
1.00-4.00
* One of the following Y-axis ranges is initially chosen depending on the parameter value at the
moment the pump timer is started. The system attempts to retain the possible range. If
necessary, the range is expanded to visualize all the sampled values.
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Options Menu Screen
Events Log
The Events Log Screen time stamps events as they occur.
Figure 5-41. Events Log Screen

1. Press to open the Events Log Screens.
2. Press the Up/Down arrows to view past events.
3. Press to return to the Options Menu Screen.
The events log icons are associated with events as indicated in Table 5-12. The most
recent events entered in the log appear at the top of the list.
Table 5-12. Events Log Icons
Icon Associated Activities

■ Starting and stopping timers.
■ Starting and stopping cardioplegia delivery.
■ Enabling and disabling the VARD Auto Mode.
■ Enabling and disabling the VARD servo (lower and upper
sensors).
■ Enabling and disabling the VLP servo.
■ Enabling and disabling the ABD.
■ Enabling and disabling the cardioplegia air sensor.
■ Safety system modifications.
■ System status messages that appear in the top line of the
message bar.
■ Bio-Pump status messages that appear in the top line of
the message bar.
■ Activation of all safety system alerts.
■ Activation of all software and hardware operation systems
alerts.
■ Activation of all safety system alarms.
■ Activation of all software and hardware operation systems
alarms.
All events captured in the Events Log Screens are downloaded onto the
CompactFlash® memory card after the Home button is pressed and while the Home
Screen is being viewed.
Note: At the conclusion of a case, allow a minimum of 10 seconds (or until the
hourglass disappears) for the data download to complete before powering off the
console.
Printer
1. Press the Printer button from the Main Menu. A query screen will appear
asking, “Do you really want to print the report sheet?” Press the green
checkmark to print. Press the red X to cancel the print request.
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Chapter 5
Servo (Resting Heart mode only)
The Printed Report
1. Hospital Information entered in the Configuration Mode.

2. Patient Information entered in the Patient Information Screen.
3. Treatment Data Events collected during cardiopulmonary bypass.
4. Treatment Data Parameters collected every 5 minutes during cardiopulmonary
bypass beginning when the pump timer is started and ending when the pump
timer is stopped.
Venous Line Pressure 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.
1. Ensure the venous line pressure is set with a fluid/air isolator and is properly
primed.
2. Ensure the VLP pressure port is zeroed and the female connector of the
pressure set luer is securely connected to the transducer port labeled VLP.
3. It is recommended that the VLP servo only be enabled when patient
hemodynamics are stable.
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Bio-Pump Configuration
Before initiating VLP servo during CPB, open the Bio-Pump Edit Screen and confirm
the settings per Figure 5-42.
3
1
4
2
Figure 5-42. Bio-Pump Settings

1. Confirm that the VLP alert pressure is set to -100 mm Hg.
2. Confirm that the Bio-Pump response to VLP alert is Message.
3. Confirm that the VLP alarm pressure is set to -200 mm Hg.
4. Confirm that the Bio-Pump response to VLP alarm is Coast.
5. Press when the Bio-Pump settings are confirmed.
Activating the VLP Servo

1
6 3
Figure 5-43. VLP Servo Operation

1. Ensure that the system status LED is green and the message bar is blank.
2. Ensure that the cardiopulmonary hemodynamics (blood flow, patient arterial
pressure, system venous line pressure) are stable and that the heart is
sufficiently decompressed.
3. Press the gray VLP Servo button on the Main Run Screen. When enabled,
■ The Servo will “capture” the current venous line pressure (VLP) and display
that pressure in a window above the enabled Servo button.
■ The Servo button will turn blue
The green/red Bio-Pump control offset indicator will appear below the VLP
■
Servo icon.
4. The servo will “capture” the venous line pressure (VLP) being displayed on the
Main Run Screen.
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 5
5. Pump RPM will adjust up or down to maintain the captured VLP.

6. If venous line pressure becomes more negative, the Bio-Pump flow is
automatically reduced to return to the captured VLP. The Bio-Pump flow
reduction is indicated by the green bar: green (real flow) is shorter than the red
(pump speed RPM knob setting).
7. If the VLP becomes less negative, the Bio-Pump flow is automatically increased
to return to VLP. Bio-Pump flow increasing is indicated by the green bar: green
(real flow) is longer than the red (pump speed RPM knob setting).
8. Bio-Pump flow increase is limited to 125% of the initial value. If the Bio-Pump
flow reaches the 125% maximum limit,
■ the top line of the message bar displays Bio-Pump high flow
■ audible alert tones will sound
Alert and Alarm Conditions

If an acute change in venous line pressure occurs and activates either the VLP alert
or the VLP alarm and the Bio-Pump response is set to Message Only, Coast, or Stop,
the VLP Servo Mode will either remain enabled or become disabled per Table 5-13.
Table 5-13. VLP Alert and Alarm
VLP ALERT VLP ALARM

Message Coast Stop Message Coast Stop
Status YELLOW RED
Light
Top (Blue) VLP OVERPRESSURE (Red) VLP OVERPRESSURE
Message
Bar
Bottom (N/A) Bio-Pump Bio-Pump (N/A)
Message Coast Stop
Bar
Acoustic ALERT ALERT ALERT ALARM ALARM ALARM
Signal
VLP REMAINS BECOMES BECOMES REMAINS BECOMES BECOMES
Servo ENABLED DISABLED DISABLED ENABLED DISABLED DISABLED
Note: The minimum flow the Bio-Pump can be reduced to is 0.5 L/min in the Coast
Mode.
The Bio-Pump Speed RPM Knob
Turning the Bio-Pump speed RPM knob will cause the red bar to move, but will not
result in a change of pump RPM or pump flow.
To discontinue VLP servo and regain manual control of Bio-Pump flow:
1. Press the VLP servo icon and the button will turn to gray.
2. If necessary, rotate the Bio-Pump speed RPM knob counterclockwise to position
the red bar shorter than the green bar.
3. When the green/red bar disappears, manual control of the Bio-Pump is regained.
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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.
1. When on CPB, make sure there is no air in the VARD.
2. Open the VARD/AAR Controller Secondary Screen and ensure that the AAR
Controller is in the Auto Mode.
3. Ensure that the system status LED is green.
4. Press the gray VARD Servo button on the Main Run Screen. When enabled, the
button will turn blue.
5. In the VARD/AAR Controller Secondary Screen, the VARD icon will change to a
button with one pair of red arrows. These arrows indicate the servo will be
activated when air is detected across the lower sensors.
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Chapter 5
6. When air is detected by the lower sensors,

■ the display “TOO MUCH AIR IN VARD: CHECK VACUUM” appears in the top
line of the message bar
■ the Bio-Pump flow reduces to a minimum of 0.5 L/min
■ the green/red Bio-Pump control offset indicator appears
■ the VARD Servo button in the Main Run Screen will display a red downward
arrow until the Bio-Pump reaches a flow of 0.5 L/min
■ audible alert tones sound
■ the red “TOO MUCH AIR IN VARD” icon appears in the Secondary Screen
■ the mechanical pinch valve automatically opens
the pinch valve icon changes to red and displays “OPEN”
■
7. When air is cleared above the lower sensors,

■ the top line in the message bar changes from “TOO MUCH AIR IN VARD:
CHECK VACUUM” to “AIR IN VARD”
■ audible alert tones remain active
■ the red “TOO MUCH AIR IN VARD” icon changes to the yellow “AIR IN VARD”
icon
■ the mechanical pinch valve remains open
■ the pinch valve icon remains red and displays “OPEN”
■ the green/red Bio-Pump control offset indicator remains active
the Bio-Pump flow remains at 0.5 L/min
■
8. When the air is cleared from the VARD,

■ the system status LED changes to green
■ the display “AIR IN VARD” clears from the top line of the message bar
■ audible alert tones stop
■ the mechanical pinch valve closes
■ the pinch valve icon changes to green and displays “CLOSED”
■ the Bio-Pump flow gradually ramps up towards normal
■ the green bar of the Bio-Pump control offset indicator will extend over the red
bar as the Bio-Pump flow returns to normal
■ the VARD Servo button in the Main Run Screen will display a red upward
arrow until the Bio-Pump flow returns to normal
■when the Bio-Pump RPM returns to the setting of the pump speed RPM knob,
the green/red Bio-Pump control offset indicator clears and the upward arrow
above the VARD servo icon clears
9. Press the VARD Device button in the Secondary Screen. The icon will display a
second pair of red arrows. These arrows indicate the servo will be activated
when air is detected across the upper pair of sensors.
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017

Preparing for Cardiopulmonary Bypass Checklist
10. The upper pair of sensors will engage the VARD servo only when they detect
small amounts of air continuously for 3 seconds and,
■ the top line of the message bar displays “AIR IN VARD”
■ the Bio-Pump flow is reduced by 10%
■ the green/red Bio-Pump control offset indicator appears
■ the top of the VARD Servo button in the Main Run Screen will display a red
downward arrow
■ audible alert tones will sound
■ the yellow “AIR IN VARD” icon appears in the secondary screen
■ the pinch valve icon turns red and displays “OPEN”
Note: The minimum flow the Bio-Pump can be reduced to is 0.5 L/min.
11. When air is cleared above the upper sensors,
■ the system status LED returns to green
■ the Bio-Pump flow ramps back up to normal
■ the VARD Servo button in the Main Run Screen will display a red upward
arrow and the Bio-Pump flow will increase by 20% every second until the
original flow is achieved
■ the “AIR IN VARD” display clears from the top line of the message bar
■ the audible alert tones stop
■ the yellow VARD icon clears from the Secondary Screen
■ the pinch valve automatically closes
■ the pinch valve icon turns green and displays “CLOSED”
■ when the actual pump RPM reaches the knob setting RPM, the green/red
Bio-Pump control offset indicator clears
12. To disable VARD servo,
■ ensure the green/red Bio-Pump control offset indicator is cleared from the
Main Run Screen
■ press the VARD Servo icon; when it turns gray, servo is disabled
Proper surgical procedures and techniques are the responsibility of the medical
professional. These instructions are provided for informational purposes only. Each
medical professional must evaluate the appropriateness of the procedure based on
his/her own medical training, experience, the type of surgical procedure, and the
patient condition.
Prior to each use, it is the responsibility of the clinician to determine that the Performer
CPB is in proper operating condition, as described in this manual. Do not use the
system if proper operating conditions are not verified.
Warning: READ CAREFULLY ALL WARNINGS, PRECAUTIONS, AND
INSTRUCTIONS FOR USE FOR ALL RELATED MEDTRONIC®
EXTRACORPOREAL DEVICES PRIOR TO USE. FAILURE TO READ AND
FOLLOW ALL INSTRUCTIONS, OR FAILURE TO OBSERVE ALL STATED
WARINGS, COULD CAUSE SERIOUS INJURY OR DEATH TO THE PATIENT.
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 5
Figure 5-44. Resting Heart Configuration
Figure 5-45. Bio-Pump CPB Configuration, Right Side, Back and Front
Figure 5-46. Oxygen-Air Blender Configuration, Left Side, Front and Back
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017

Ensure all brackets, holders, and accessories (O2-Air Blender, anesthesia

vaporizer) are properly mounted, positioned and secured to their respective
poles.
Ensure the Performer CPB is running on AC power and has passed the Power
On Self-Test. (See “Power On Self-Test” on page 5-17.)
Adjust the height of the console according to the procedure being conducted.
Ensure the Performer CPB is properly configured per the Department of
Perfusion Policy and Procedure Manual or conforms to the hospital's protocols
for conducting extracorporeal support procedures. (See “System Configuration”
on page 5-16.)
Confirm a CompactFlash® memory card with sufficient available memory is
inserted into the PCMCIA slot and the indicator LED is green. (See
“CompactFlash® Memory Card with PCMCIA Adapter Installation” on
page 5-15.)
Confirm that the CID is functioning properly.
Confirm that the roller pump insert is properly “sized” for the tubing being used
in the roller pump.
Turn on each roller pump and ensure they are functioning properly.
Confirm that the rotation of each roller pump conforms to the intended direction
of forward flow for the tubing in the pump.
Confirm that the battery is fully-charged. (See “Checking the Battery” on
page 5-44.)
Confirm that the uninterruptible power supply is functioning properly by briefly
disconnecting the AC power cord from the electrical source. (See “Checking the
Battery” on page 5-44.)
Confirm that the extracorporeal circuit is properly assembled, set up, and
primed according to the product and manufacturer's recommendations or
Instructions for Use.
Warning: Ensure that all components in the circuit have been debubbled and primed
properly prior to beginning bypass to minimize the risk of air reaching the patient. If
air bubbles or leaks are observed during priming and/or operation, these conditions
may result in air embolism to the patient and/or fluid loss.
Connect the ultrasonic flow transducer to the arterial line. Confirm proper
orientation. (See “Setup and Operation of the Arterial Line ABD System” on
page 5-63.)
Zero the pressure transducers. (See “Zeroing the Pressure Transducers” on
page 5-87.) Connect the pressure monitoring lines. (See “Pressure Monitoring
Sets with Air/Fluid Isolators Setup” on page 5-88.) Confirm that the alert and
alarm safety limits are properly configured. (See “Editing Pressure Limits for the
Current Case Only” on page 5-85.)
Confirm that the minimum flow limit is properly set.
Connect the Venous Saturation/Hematocrit transducer to the in-line cuvette.
Confirm that the alert values for OXYGEN SATURATION: LOW VALUE and
HEMATOCRIT: LOW VALUE are properly set. (See “Venous Saturation and
Hematocrit Monitoring” on page 5-90.)
Connect the temperature probes between the HTS Module and either the
extracorporeal circuit or the patient.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 5
Initiating Extracorporeal Support Checklist
When using the Medtronic Resting Heart Module and running the Performer
CPB in Resting Heart mode, confirm that the VARD cable is connected to the
console.
When using the Medtronic Resting Heart Module and running the Performer
CPB in Resting Heart mode, confirm that the wall vacuum pressure displayed
in the AAR Controller screen is set between -200 mm Hg and -210 mm Hg.
Enable each safety device using the buttons on the CID and confirm their proper
functionality.
a. Arterial Air Bubble Detection (ABD) (See “Setup and Operation of the Arterial
Line ABD System” on page 5-63.)
b. AAR Controller in Auto Mode when running the Performer CPB in Resting
Heart mode.
c. Level Detection when running the Performer CPB in Bio-Pump CPB mode (see
“Set-up and Operation of the Level Sensing System” on page 5-67).
d. Arterial Backflow Prevention when running the Performer CPB in Bio-Pump
CPB mode (see “AutoClamp System (Bio-Pump CPB mode only)” on
page 5-73).
Turn the Bio-Pump speed RPM knob clockwise and confirm proper functionality
of the Bio-Pump.
Open the Patient Information Secondary Screen and enter the patient ID,
height, weight, the circuit prime volume, anesthesia IV fluid volume infused, and
pre-bypass laboratory hemoglobin and hematocrit values.
Confirm that the system status LED is green and there are no alerts in the
message bar. If the LED is yellow, reference the alert(s) in the top line of the
message bar. Do not initiate extracorporeal support until all alert conditions
have been corrected and the system status LED is green.
Confirm that a Bio-Pump handcrank is immediately available for emergency
use.

should use the Performer CPB. The operation of the system requires constant
Warning: Ensure that all components in the circuit have been debubbled and primed
properly prior to beginning bypass to minimize the risk of air reaching the patient. If
air bubbles or leaks are observed during priming and/or operation, these conditions
may result in air embolism to the patient and/or fluid loss.
Warning: Ensure all patient intravenous fluid lines are connected securely to prevent
air entrainment.
Warning: All gaseous bubbles have the potential for gaseous emboli and must be
handled carefully. Safety/Warning devices are recommended to aid in the detection
and elimination of gaseous bubbles in the extracorporeal circuit.
Position the Performer CPB next to the patient and set the wheel brakes.
Check for adequate levels of anticoagulation prior to initiation of bypass.
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017

Warning: A strict anticoagulation protocol should be followed and anticoagulation

should be routinely monitored during all procedures. The benefits of extracorporeal
support must be weighed against the risk of systemic anticoagulation and must be
assessed by the prescribing physician. Adequate heparinization must be maintained
before and during bypass.
Cannulate the patient for arterial and venous vascular access.
Clamp the arterial and venous circuits.
Connect the arterial line and thoroughly de-air the cannula-circuit connection.
Connect the venous line and thoroughly de-air the cannula-circuit connection.
If indicated, perform retrograde autologous prime per patient tolerance.
Set the FiO2 on the oxygen-air blender per the manufacturer's
recommendations for the membrane oxygenator being used.
Set the gas flow on the oxygen-air blender per the manufacturer's
recommendations for the membrane oxygenator being used.
Turn the Bio-Pump speed RPM knob clockwise and increase pump RPM
sufficient to generate a pressure that will prevent backflow.
Release the arterial and venous clamps on the extracorporeal circuit and
gradually increase 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 when running the Resting Heart mode. Failure to do this
could allow backflow and exsanguinate the patient.
■ Connect the AutoClamp System and enable Backflow Prevention when
running the Bio-Pump CPB mode.Failure to do this could allow arterial
backflow and introduce air into the arterial circuit.
Start the pump timer. (See “Pump and Clamp Timer Operation” on page 5-46.)
Resting Heart mode:

Reference the Main Run Screen of the CID to assess the adequacy of venous
return.
a. Check the Venous Line Pressure (VLP). (See “Main Run Screen” on
page 5-41.)
b. Closely monitor the VLP. Adjust blood flow or administer volume as necessary
to ensure that the negative pressure does not become more negative than -60
mm Hg.
Reference the Main Run Screen of the CID to assess the adequacy of arterial
flow.
a. Pump Flow
b. Pump RPM
c. Cardiac Index
d. Arterial Line Pressure (ALP)
e. Venous Saturation (OXYGEN SAT)
Warning: Frequent patient and system monitoring is recommended. Do not leave the
system unattended while in use.
Adjust the pump flow as necessary to achieve an OXYGEN SAT that conforms
to practice guidelines.
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 5
Adjust the pump flow as necessary to achieve a patient Mean Arterial Pressure
(MAP) monitored on the physiologic monitor that conforms to practice
guidelines.
Respond immediately to correct any system alarm that occurs as indicated by
distinct audible cues concomitant with the following visual cues on the CID:
a. the system status LED will change to red
b. the message bar will change to red
c. a description of the alarm will appear in the top line of the message bar
Respond appropriately to correct any system alert that occurs as indicated by
a. the system status LED will change to yellow
b. a description of the alert will appear in the top line of the message bar
Bio-Pump CPB mode:

Closely monitor the blood level in the venous reservoir to assess the adequacy
of venous return.
a. Reduce Bio-Pump flow if the blood volume drops to the manufacturer's
recommended safe minimum reservoir operating level.
b. Connect and enable the reservoir level safety system to prevent emptying the
venous reservoir. (See page 5-67)
Reference the Main Run Screen of the CID to assess the adequacy of arterial
flow. (See “Main Run Screen” on page 5-41)
a. Pump Flow
b. Pump RPM
c. Cardiac Index
d. Arterial Line Pressure (ALP)
e. Venous Saturation (OXYGEN SAT)
Warning: Frequent patient and system monitoring is recommended. Do not leave the
system unattended while in use.
While closely monitoring the blood level in the venous reservoir, adjust the pump
flow as necessary to achieve an OXYGEN SAT that conforms to practice
guidelines.
While closely monitoring the blood level in the venous reservoir, adjust the pump
flow as necessary to achieve a patient Mean Arterial Pressure (MAP) monitored
on the physiologic monitor that conforms to practice guidelines.
Respond immediately to correct any system alarm that occurs as indicated by
a. the system status LED will change to red.
b. the message bar will change to red.
c. a description of the alarm will appear in the top line of the message bar.
Respond appropriately to correct any system alert that occurs as indicated by
a. the system status LED will change to yellow.
b. a description of the alert will appear in the top line of the message bar.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Cleaning and Maintenance

6
6
Cleaning 6-2
Maintenance 6-2
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 6
Cleaning
Cleaning
■ Unplug the equipment before cleaning to avoid electrical shock.
■ Do not use chemical solvents such as methyl ethyl ketone, alcohol, ether,
acetone, FORANE®, or acid based solutions in or on any part of the equipment,
as such solvents may be destructive to the device and its internal components.
Do not use abrasive cleaners or cleaning solvents other than those recommended
in this manual.
■ The surface of the whole system (including pump heads, tube occlusion roller,
and tube guide rolls) shall be thoroughly cleaned after each use, in order to avoid
the accumulation of contaminated or corrosive fluids.
■ All the external surfaces can be easily cleaned and disinfected for blood, saline,
or other spilled contaminants using normal medial equipment cleaners and
disinfectants such as bleach (5.25%) and hydrogen peroxide (3%).
Note: The Level Sensors’ “sensing suface” may be cleaned with isopropyl
alcohol.
■ Because fluids should not be allowed to enter any openings, do not apply cleaning
solution with a spray.
■ Clean the equipment with a sponge or soft cloth moistened with water or a mild
detergent.
■ After the equipment is cleaned, wipe the unit with a cloth moistened with water to
remove any cleaning solution residue and then wipe the unit with a dry cloth.
■ If it is suspected that fluid penetrated into the equipment, the unit should be
unplugged and immediately examined by a trained, service technician.
■ Clean the VARD FIL and the cardioplegia air bubble sensor channels to ensure
maximum sensor sensitivity.
■ Do not use alcohol on the VARD sensor cable ends where the connectors are
exposed.
Maintenance
■ It is recommended that preventative maintenance be completed every 6 months
to ensure accurate performance and reliability and to guarantee safe use of the
equipment.
■ The user is not in charge of particular maintenance operations. All maintenance
is performed by authorized, service personnel.
■ Setup operations, updates, modifications, and repairs must be performed by
trained personnel authorized by the manufacturer with authorized parts from the
manufacturer.
■ Only trained personnel authorized by the manufacturer are allowed to access the
internal parts of the equipment.
User Maintenance Checks

Test the Uninterruptible Power Supply (UPS) every three months using the following
procedure, or sooner if you suspect the battery readings are incorrect.
When the entire system is operating with tubing in the pumps, temporarily disconnect
the wall power supply.
1. Check that the audible battery alert tones sound.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Cleaning and Maintenance

Maintenance
2. Check the power status icon on the CID changes to indicate Battery Power.
3. Confirm the message BATTERY MODE is displayed in the top line of the
Message Bar.
4. Check the power status icon for the estimated battery time remaining as the
battery discharges. The battery should begin with at least 30 minutes of power.
Run the system for 30 minutes on battery power and monitor the power status icon in
the CID for the estimated battery time remaining. Recharge the batteries by operating
the system using wall power supply with the system power on.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 6
Maintenance
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Troubleshooting 7
General Information 7-2
Alarms 7-2
Alerts 7-2
Simultaneous Activation of Alarms/Alerts 7-2
Priority of Alarms 7-3
Alarm Resetting 7-3
Self-Resetting Alarms 7-4
Emergency Procedures 7-4
Alarms 7-20
Alerts 7-27
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 7
General Information
General Information
The equipment is designed to signal situations requiring the user's intervention.

Two types of signals can be distinguished:
■ Alarms
■ Alerts
Alarms
Alarms are activated when the equipment malfunctions or when an EVENT condition
occurs that might jeopardize the patient's safety.
An alarm condition is signaled to the user by:
■ illumination of the red system status LED on the top of the display
■ the sounding of an audible signal with a 1-second frequency
■ the message bar changing to a red background
■ a description of the alarm is present in the top line of the message bar (black text
on red background)
Alarms Conditions and Messages

A complete list of conditions that may activate an alarm message can be found in the
table beginning on page 7-20.
Alerts
Alerts are activated every time the user's attention or intervention is required, but the
patient's safety and the equipment functionality are not jeopardized.
Alerts are signaled to the user by:
■ illumination of the yellow system status LED on the top of the display
■ the sounding of an audible signal with a 1-minute frequency
■ a description of the alert is present in the top line of the message bar (yellow text
on blue background)
Alert Conditions and Messages

A complete list of conditions that may activate an alarm message can be found in the
table beginning on page 7-27.
Simultaneous Activation of Alarms/Alerts

The top line of the Message Bar in the CID displays alarm and alert conditions
according to their priority. If more than one alarm/alert is present, the equipment will
function in the following ways:
■ If only alerts are active, they are cyclically browsed at 1.5-second intervals. Alerts
do not have an order of priority.
■ If only alarms are active, the alarm with the highest priority is displayed in the top
line of the Message Bar until cleared. If a second alarm condition still exists after
the first has been cleared, then that alarm condition will be displayed in the top
line of the Message Bar.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Troubleshooting
General Information
■ If both alarms and alerts are simultaneously active, the alarms are first displayed
in order of their priority. Once all the alarm conditions have been removed, the top
line of the Message Bar will cyclically display the alert conditions at 1.5-second
intervals.
■ At any time during the case, the user can view all alarms and alert messages and
the time the condition occurred by pressing the Events Log Button.
Priority of Alarms
Alarm conditions will be displayed in the top line of the Message Bar according to the
following priority:
1. Air detected by ABD
2. Too much air in VARD: Check Vacuum
3. VLP overpressure
4. Bio-Pump excessive stop
5. VARD: blood being removed
6. ALP overpressure
7. Pinch-valve not closed
8. Pinch-valve not opened
9. Air in cardioplegia circuit
10. PR4 (cardioplegia circuit) overpressure
11. PR1 overpressure
1. AutoClamp Not Open
2. Air Detected by ABD
3. Bio-Pump Excessive Stop
4. ALP Overpressure
5. Air in cardioplegia circuit
6. Level Sensor Error
7. Low Blood Level
8. AutoClamp Not Closed
9. AutoClamp Closed and Flow Still Present
10. PR4 (cardioplegia) overpressure
Alarm Resetting
■ When an alarm occurs, the “alarm mute” icon ( ) is shown at the right of the
message bar.
■ To mute the alarm, the user should press the “alarm mute” icon.
■ Once the cause of the alarm is cleared, the user should reset
the alarm by pressing the “confirmation” icon ( ) shown at the right of the
message bar.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 7
Emergency Procedures
Self-Resetting Alarms
The following alarms will automatically reset once the alarm condition is removed:
■ Pressure alarms
■ Pinch valve alarms
■ Too much air in VARD: Check Vacuum
■ Pressure alarms
■ Low Blood level alarms
This section is intended to assist the user to operate the Performer CPB in a proficient
manner should an actual emergency occur. It is recommended to practice operating
the system using a bench-model or “wet-run” circuit.
Air Detected by ABD

This section assumes:
■ the Bio-Pump has been configured to either Stop, Coast, or Message in response
to the alarm “AIR DETECTED BY ABD”
■ the arterial line Air Bubble Detector/blood flow sensor is properly positioned on
the circuit
■ the ABD has been enabled in the Main Run Screen
The immediate indications of an emergency condition are:

■ the sounding of distinct audible alarm tones
■ the message bar turns red
■ “AIR DETECTED BY ABD” appears in the top line of the message bar
■ the ABD icon in the Main Run Screen indicates “AIR DETECTED BY ABD”
User Interventions when runing Resting Heart mode and Bio-Pump CPB mode
without the AutoClamp:
■ If the Bio-Pump has been configured to Message Only, immediately turn the
Bio-Pump speed RPM knob fully counterclockwise to stop the pump and
immediately clamp the arterial and venous lines.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Troubleshooting
■ If the Bio-Pump has been configured to Stop or Coast, immediately clamp the
arterial line to prevent backflow.
■ Immediately clamp the venous line to prevent exsanguination of the patient
(Bio-Pump CPB mode).
■ Confirm the event by reading the message “AIR DETECTED BY ABD” in the top
line of the message bar.
■ Immediately identify the cause for the emergency condition.
■ Ensure the cardioplegia pump(s) PM3 and/or PM4 and the LV vent pump PM2 are
stopped. It is recommended to configure the roller pump response for PM2, PM3,
and PM4 to Stop for the event Bio-Pump Coast or Bio-Pump Stop.
■ Mute the alarm as required.
■ Clear all air from the circuit.
■ Reset the air bubble detection safety system so that it is enabled.
■ To resume cardiopulmonary bypass, the Bio-Pump speed RPM knob must be
turned fully counterclockwise to restart the Bio-Pump.
■ Increase the Bio-Pump RPM to a speed that will produce the minimal amount of
forward flow. Remove the arterial clamp and confirm the Bio-Pump is generating
forward flow. Remove the venous line clamp and resume cardiopulmonary
bypass.
User Interventions when running Bio-Pump CPB mode with AutoClamp:
Bio-Pump speed RPM knob fully counterclockwise to stop the pump and
immediately clamp the arterial and venous lines.
■ If the AutoClamp has been configured to CLOSE in response to Bio-Pump Stop
or Bio-Pump Coast, immediately clamp the venous line to prevent exsanguination
of the patient.
■ Confirm the event by reading the message "AIR DETECTED BY ABD" in the top
line of the message bar.
■ Mute the alarm as required.
Warning: Do not open the RTC after automatic closure prior to removing all air from
the circuit and confirming complete absence of air in the arterial circuit.
■ Reset the air bubble detection safety system so that it is enabled.
■ To resume cardiopulmonary bypass, the Bio-Pump speed RPM knob must be
turned fully counterclockwise to resume forward flow.
■ Increase the Bio-Pump RPM to > 2200. Press the AutoClamp button in the Main
Run Screen to open the RTC.
■ Confirm the Bio-Pump is generating forward flow. Remove the venous line clamp
and resume cardiopulmonary bypass.
■ Press the AutoClamp button to enable.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 7
Too Much Air in VARD: Check Vacuum (Resting Heart mode only)
This alarm condition occurs when the VARD/AAR Controller is in the AUTO Mode and
the fluid level in the VARD drops below the lower pair of sensors. The immediate
indications are:
■ The system status LED changes to red
■ “TOO MUCH AIR IN VARD: CHECK VACUUM” appears in the top line of the
message bar
User Intervention:
1. Bio-Pump flow reduction may be required until venous air is reduced or
eliminated. The Bio-Pump will automatically reduce flow if it is configured to
Coast or Stop in response to this alarm condition.
2. Check the position of the venous cannula for the possibility of openings being
outside the heart and exposed to the atmosphere.
3. Check the security of the venous cannula purse string for the possibility of
entraining air around the cannulation site.
4. Check for loose connections and luer fittings on the venous line proximal to the
VARD.
5. Ensure the AAR Controller vacuum is set between -200 mm Hg and -210 mm
Hg.
6. Once the fluid level in the VARD is above the lower pair of sensors, the alarm
indications will automatically clear.
Low Blood Level (Bio-Pump CPB mode only)

This alarm condition occurs when the fluid level drops below the position of the red
(alarm) sensor on the reservoir. The immediate indications are:
■ "LOW BLOOD LEVEL" appears in the top line of the message bar
User Intervention:
■ Bio-Pump flow reduction may be required until the volume in the reservoir returns
above the position of the sensor. The Bio-Pump will automatically reduce flow if it
is configured to Stop or Coast in response to this alarm condition.
arterial line to prevent backflow unless the AutoClamp feature is enabled and
configured to CLOSE in response to Bio-Pump Stop or Bio-Pump Coast.
■ Confirm the event by reading the alarm message "LOW BLOOD LEVEL" in the
top line of the red message bar.
■ Check the position of the venous cannula for the possibility that gravity venous
drainage is restricted.
■ Check the security of the venous cannula purse string for the possibility of
entraining air around the cannulation site.
■ If necessary, add volume to the reservoir.
Once the fluid level in the reservoir returns above the red sensor, the alarm indications
will automatically clear.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Troubleshooting
■ To resume cardiopulmonary bypass from the Bio-Pump Stop mode, the

Bio-Pump speed RPM knob must be turned fully counterclockwise to resume
forward flow.
■ Increase the Bio-Pump RPM to a speed to > 2200.
■ Remove the clamp on the arterial line. If using the AutoClamp feature, press the
AutoClamp button in the Main Run Screen to open the RTC. Confirm the
Bio-Pump is generating forward flow.
■ If the Bio-Pump is configured to Coast, the pump speed will automatically
ramp up. If using the AutoClamp feature, the RTC will automatically open
when the Bio-Pump motor reaches 2200 RPM.
■ Monitor the volume in the reservoir while pump flow is being returned to
normal.
Level Sensor Failure (Bio-Pump CPB mode only)

This condition occurs when the sensors are incorrectly placed on the reservoir (the
red alarm sensor detects air while the yellow alert sensor detects fluid) or if a sensor
is damaged. The immediate indications are:
■ A distinct audible alarm tone sounds
■ “LEVEL SENSORS ERROR” appears in the top line of the message bar
User Intervention:
■ Mute the alarm
■ Disable the level sensing system
■ Reposition the sensors. Confirm the yellow alert sensor is positioned on the
reservoir above the alarm sensor. Ensure that the sensor positions on the
reservoir are more than 1 cm away from internal structures of the reservoir.
■ Confirm the "arrows" on the reservoir icon in the Main Run Screen change to
green when detecting fluid.
■ Reset the alarm. The System Status LED will change to yellow.
■ Press the level sensing button to enable the Level Sensing system. The System
Status LED will change to green.
■ If the sensors do not detect fluid, contact a Medtronic Service representative.
Overpressure Alarm
When a pressure exceeds the user-defined alarm limit:
■ A distinct audible alarm tone sounds
■ The top line of the message bar displays the pressure channel that was exceeded
(OVERPRESSURE ALARM: ALP, OVERPRESSURE ALARM: PR4, etc)
■ The appropriate pressure pop-up window will appear
■ Pump speed(s) may change depending on the factory default pump responses,
configuration settings, or changes made during editing pump responses.
If the pump response is set to Stop, Coast (Bio-Pump), or Pause (Roller Pump):
■ The pressure will drop below the alarm limit and the alarm indicators will clear
automatically
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 7
■ The pressure pop-up window will remain visible

User Intervention for OVERPRESSURE ALARM for pressure channels PR1, PR2,
PR3, and PR4:
1. Correct the high pressure condition.
2. If necessary, reset the value for the pressure limit using the pressure pop-up
Caution: When the alarm pressure limit pop-up window is visible, the buttons in
the secondary screen become inactive. The top button in the pop-up window
displaying the pressure limit value must be pressed to clear the pop-up window
before the buttons in the secondary screen become active.
3. Start the pump(s) if configured to Stop for an alarm condition.
User Interventions for OVERPRESSURE ALARM: ALP when running RESTING
HEART mode or BIO-PUMP CPB mode without the AutoClamp:
Bio-Pump speed RPM knob counterclockwise to reduce line pressure below the
alarm limit setting.
arterial line to prevent backflow.
■ Immediately clamp the venous line to prevent exsanguination of the patient
(BIO-PUMP CPB mode).
■ Confirm the event by reading the message "OVERPRESSURE ALARM: ALP" in
the top line of the message bar.
and PM4 to Stop for the event Bio-Pump Stop or Bio-Pump Coast.
■ Immediately identify and correct the cause for the Overpressure condition.
■ If necessary, reset the value for the pressure limit using the pressure pop-up
Bio-Pump speed RPM knob must be turned fully counterclockwise to resume
forward flow.
■ Increase the Bio-Pump RPM to > 2200.
ramp up when the pressure drops below the Alarm limit value.
■ Remove the clamp on the arterial line. Confirm the Bio-Pump is generating
bypass.
User Interventions for OVERPRESSURE ALARM: ALP when running Bio-Pump
CPB mode with AutoClamp:
Bio-Pump speed RPM knob counterclockwise to reduce line pressure below the
alarm limit setting.
■ If the AutoClamp has been configured to CLOSE in response to Bio-Pump Stop
or Bio-Pump Coast, immediately clamp the venous line to prevent exsanguination
of the patient.
■ Confirm the event by reading the message "OVERPRESSURE ALARM: ALP" in
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Troubleshooting
■ Immediately identify and correct the cause for the Overpressure condition.
■ If necessary, reset the value for the pressure limit using the pressure pop-up
■ To resume cardiopulmonary bypass from the Bio-Pump Stop mode, the Bio-Pump
speed RPM knob must be turned fully counterclockwise to resume forward flow.
■ Increase the Bio-Pump RPM to > 2200.
■ Press the AutoClamp button in the Main Run Screen to open the RTC.
ramp up when the pressure drops below the Alarm limit value and the RTC
will automatically open when the RPM reaches 2200.
■ Confirm the Bio-Pump is generating forward flow. Remove the venous line clamp
and resume cardiopulmonary bypass.
■ Press the AutoClamp button to enable.
Bio-Pump Excessive Stop

This alarm condition occurs when the Pump Timer is running and the Bio-Pump has
been in the Stop Mode for more than 60 seconds. The immediate indications are:
■ The System Status LED changes to Red
■ “BIO-PUMP EXCESSIVE STOP” appears in the top line of the message bar
User Intervention:
1. Confirm whether the pump timer is suppose to be running or stopped.
2. If indicated, press the Pump Timer Stop button. The Bio-Pump Excessive Stop
alarm will clear.
3. Correct the condition that caused the Bio-Pump to stop and then restart the
Bio-Pump.
4. Reset the alarm.
VARD: Blood Being Removed (Resting Heart mode only)

the FIL Sensor detects fluid for 3 or more consecutive seconds. The immediate
indications are:
■ “VARD: BLOOD BEING REMOVED” appears in the top line of the message bar
User Intervention:
1. Confirm the presence of venous air causing the condition of either the AIR IN
VARD alert or the TOO MUCH AIR IN VARD: CHECK VACUUM alarm.
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 7
2. If there is no AIR IN VARD alert or TOO MUCH AIR IN VARD: CHECK VACUUM
alarm, immediately clamp the VARD purge line.
3. Correct the condition causing the Pinch Valve to remain open.
4. Reset the alarm if necessary.
Pinch Valve Not Closed (Resting Heart mode only)

the sensors that detect the position of the Pinch Valve indicate the Pinch Valve is open
when the conditions maintain it should be closed. This condition will be caused by the
user manually pressing the mechanical Button on top of the Pinch Valve. This
condition may result in excess blood being removed through the VARD Purge Line.
The immediate indications are:
■ “VARD: PINCH VALVE NOT CLOSED” appears in the top line of the message bar
User Interventions:
1. Do not press the Mechanical Button when the VARD/AAR Controller is in the
Auto Mode.
2. Immediately clamp the VARD Purge Line.
3. Closely monitor the venous line for introduction of air into the VARD.
4. Closely monitor the VARD for the accumulation of air.
5. Unclamp the VARD purge line when the system alerts “AIR IN VARD”
6. Unclamp the VARD purge line when the system alarms “TOO MUCH AIR IN
VARD: CHECK VACUUM.”
Pinch Valve Not Open (Resting Heart mode only)

the sensors that detect the position of the Pinch Valve indicate the Pinch Valve is
closed when the conditions maintain it should be open (ie, during AIR IN VARD or
TOO MUCH AIR IN VARD: CHECK VACUUM conditions). This may result in venous
air not being removed from the VARD. The immediate indications are
■ “VARD: PINCH VALVE NOT OPEN” appears in the top line of the message bar
User Interventions:
1. Press the Pinch Valve icon in the VARD/AAR Controller screen. This will cause
the pinch valve to open for 0.5 seconds and then close.
2. If the Pinch Valve fails to open when pressing the Pinch Valve icon, press on the
Mechanical Button to open the Pinch Valve when the system alerts AIR IN VARD
3. Press on the Mechanical Button to open the Pinch Valve when the system
alarms TOO MUCH AIR IN VARD: CHECK VACCUM
4. Closely monitor the VARD for the accumulation of air.
5. Reset the alarm as necessary.
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Troubleshooting
CPG Air Detected

This section assumes:
■ the cardioplegia roller pump (PM4) has been configured to either Stop, Pause, or
Message Only in response to the event “AIR IN CARDIOPLEGIA CIRCUIT”
■ the cardioplegia circuit pump outlet line is properly positioned in the air sensor
and the ABD has been enabled in the Cardioplegia Run Screen
Cardioplegia Run Screen: CPG Air Sensor Enabled

■ the sounding of distinct audible alarm tones
■ the message bar turns red
■ “AIR IN CARDIOPLEGIA CIRCUIT” appears in the top line of the message bar
■ the cardioplegia ABD icon changes to red
User Interventions:
■ If the CPG roller pump (PM4) has been configured to Message Only, immediately
turn the roller pump speed control knob fully counterclockwise to stop the pump
and immediately clamp the delivery line.
■ If the CPG roller pump (PM4) has been configured to Stop or Coast, immediately
clamp the delivery line.
■ Confirm the event by reading the message “AIR IN CARDIOPLEGIA CIRCUIT” in
■ Mute the alarm as required by pressing the Alarm Mute button once.
Warning: Pressing the cardioplegia ABD icon to silence the alarm will also disable
the cardioplegia ABD, indicated by the ABD icon changing to gray. The alert
“CARDIOPLEGIA AIR SENSOR DISABLED” will appear in the top line of the
message bar and the system status LED will change to yellow.
■ Ensure the cardioplegia ABD is reset and that it is enabled and the cardioplegia
ABD icon is green.
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 7
■ Remove the clamp and resume cardioplegia delivery by turning the roller pump
speed control knob slowly clockwise.
AutoClamp Not Closed (Bio-Pump CPB mode only)

Gas pressure keeps the RTC in the OPEN position. When gas pressure is released,
the RTC closes. This alarm condition occurs when sensors that detect the position of
the Remote Tube Clamp indicate it is open when the conditions maintain it should be
closed. This condition may result in arterial backflow and entrainment of air into the
arterial line.
The immediate indications are:
■ “AUTOCLAMP NOT CLOSED” appears in the top line of the message bar.
User Interventions:
■ If the Bio-Pump speed has been reduced below 2000 RPM or has automatically
entered the Stop or Coast mode, immediately clamp the arterial line to prevent
backflow and the venous line to prevent exsanguination.
Note: This alarm indication displayed in the red Message Bar will prevent viewing the
alert BIOPUMP BACKFLOW. Reference the Events Log screen to confirm the
sequence of potential events (BIOPUMP STOP or BIOPUMP COAST, BIOPUMP
BACKFLOW, AUTOCLAMP NOT CLOSED) associated with this alarm condition.
■ Ensure the AutoClamp button on the Main Run Screen is green to indicate the
system is ON.
■ Ensure the communication cable between the RTC and the ACI module is
properly connected.
■ Ensure the communication cable between the ACI Module and the Performer
CPB Console is properly connected.
■ Ensure the 3/8" ID tube is properly seated in the RTC.
■ Immediately identify and correct the event that would cause the Bio-Pump flow to
be reduced or to enter the Stop or Coast mode
Bio-Pump speed RPM knob must be turned fully counterclockwise. To resume
forward flow, increase the Bio-Pump RPM to >2200.
ramp up when causative event has been corrected.
■ Remove the clamp on the arterial line. Confirm the Bio-Pump is generating
bypass.
■ Contact the Medtronic Service representative.
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Troubleshooting
AutoClamp Not Open (Bio-Pump CPB mode only)

the RTC closes. This alarm condition occurs when the sensors that detect the position
of the Remote Tube Clamp indicate it is closed when the conditions maintain it should
be open. This condition will prevent delivery of blood flow. The immediate indications
are:
■ "AUTOCLAMP NOT OPEN" appears in the top line of the message bar.
User Interventions:
■ Confirm gas pressure lines are properly connected to the ACI Module and the
RTC.
■ Confirm the Events Log Screen is not displaying the alert AUTOCLAMP
PRESSURE LOW.
■ Ensure the AutoClamp button on the Main Run Screen is green to indicate the
system is ON.
■ Press the green AutoClamp button on the Main Run Screen to disable the
AutoClamp and open the RTC. The button will change to gray with a red X.
■ If the RTC fails to open, remove the tubing from the RTC and resume
cardiopulmonary bypass.
■ Closely monitor the system for changes in Bio-Pump RPM that may precipitate a
backflow condition. When necessary, use tubing forceps to clamp the arterial line
for backflow prevention.
■ Contact the Medtronic Service representative.
AutoClamp Closed and Flow Still Present (Bio-Pump CPB mode only)
the RTC closes. This alarm condition occurs when the RTC is closed but the
ultrasonic flow sensor on the arterial line still detects blood flow when it should be 0.00
L/min. The immediate indications are:
■ “AUTOCLAMP CLOSED AND FLOW STILL PRESENT” appears in the top line of
the message bar.
User Interventions:
■ If the Bio-Pump speed has been reduced below 2000 RPM or has automatically
entered the Stop or Coast mode, immediately clamp the arterial line to prevent
backflow and the venous line to prevent exsanguination.
Note: This alarm indication displayed in the red Message Bar will prevent viewing the
alert BIOPUMP BACKFLOW. Reference the Events Log screen to confirm the
sequence of potential events (BIOPUMP STOP or BIOPUMP COAST, BIOPUMP
BACKFLOW, AUTOCLAMP CLOSED AND FLOW STILL PRESENT) associated with
this alarm condition.
■ Confirm the ultrasonic flow sensor is distal to the arterial filter and is not detecting
flow through a purge line.
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 7
■ Ensure the 3/8" ID tube is properly seated in the RTC and the RTC door is fully
closed.
■ To reposition the tube, press the red AutoClamp button on the Main Run Screen
to disable the AutoClamp and open the RTC. The button will change to gray with
a red X.
■ Unclamp the arterial and venous lines and resume cardiopulmonary bypass.
■ Press the gray AutoClamp button in the Main Run Screen to turn the AutoClamp
System to ON. The button will turn green.
■ If the alarm condition recurs, contact the Medtronic Service representative.
Unexpected and Immediate Initiation of Cardiopulmonary Bypass With a Primed Resting

Heart™ System (Resting Heart mode only)
Note: The system does not require pre-bypass setup or calibration procedures using
the CID in order to emergently initiate cardiopulmonary bypass. The system can
provide Bio-Pump and roller pump functionality 20 seconds after turning the power
on.
■ Press the Main Power switch.
■ Ensure flow and Sat/Hct sensors are properly connected.
■ Connect the arterial air/fluid isolator to the pressure port labeled ALP.
■ Connect the venous air/fluid isolator to the pressure port labeled VLP.
■ Insert the VARD purge line into the pinch valve and connect the vacuum pressure
line to PR7.
■ Turn on wall vacuum and set the regulator to -225 mm Hg
■ Connect arterial and venous lines to the patient cannulae.
■ Turn the Bio-Pump speed RPM knob to 800 RPM.
■ Remove the venous line clamp.
■ Remove the arterial line clamp and slowly increase the Bio-Pump speed control
to initiate cardiopulmonary bypass.
■ Blood flow is displayed in the LEDs on the Bio-Pump control panel.

■ Venous Line Pressure (VLP) and Bio-Pump RPM are displayed in the LCDs on
the Bio-Pump control panel.
■ Verify stable conduct of perfusion, then open the CID and enter “Resting Heart.”
Loss of AC Power Supply

Note the battery power status indicator and monitor during use. When the time
remaining reaches 5 minutes:
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Troubleshooting
■ The top line of the message reads “LOW BATTERY”

■ The audible alarm tone sounds
Loss or Failure of Battery Power: Total System Power Failure

In the event the system fails to automatically convert to battery power, or the system
has been operating on battery backup to the extent that battery power has been
completely drained:
■ Use manual operation of the Bio-Pump with the external handcrank to maintain
patient circulation
■ Use manual operation of the roller pumps with the integrated handcranks.
■ If using the AutoClamp System, clamp the arterial line and remove the arterial line
from the Remote Tube Clamp.
Warning: If a partially charged battery is used, there may be less than 30 minutes of
battery power available.
Warning: When the Uninterruptable Power Supply (UPS) converts the system to
battery power, ALL pumps, pump functions, safety systems, alerts, alarms, monitors,
CID Failure
In the event the CID malfunctions, causing the screen to “lock up” or go blank, the LCD
on the Bio-Pump control panel serves as the emergency backup monitoring screen.
The following parameters can be monitored:
■ Bio-Pump RPM
■ Venous Line Pressure
■ Arterial Line Pressure
■ Cardioplegia Line Pressure (PR4)
■ Venous Saturation
■ Hematocrit
During CID malfunction, ALL safety connections and servos that were enabled using
the CID before it failed would still be enabled and functional. This would include:
■ Arterial Line Air Bubble Detection
■ Cardioplegia Air Bubble Detection
■ Air-In-VARD Alert
■ Too Much Air In VARD Alarm
■ Pressure Alert and Alarm Safety Limits
■ Bio-Pump Low Flow
■ Bio-Pump Backflow
■ Minimum Hct
■ VLP Servo
■ VARD Servo
Without the utility of the screen to manage an alarm condition in the event one is
activated, it is necessary to disable all alarms. Enabling the Emergency Mode will
temporarily disable all system alarms and servos.
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 7
Warning: If the CID ceases to function, the Bio-Pump and the roller pumps will
continue to operate through the local controls on the front panel of the console.
Warning: If the CID ceases to function when there are safety systems enabled, the
user will not be able to intervene (eg, mute an audible alarm, reset a safety device) in
the event an alert or alarm is activated.
Warning: If the CID ceases to function, DO NOT turn the power off in an attempt to
reset or reboot the system.
1. To enable the Emergency Mode, press both scroll arrows simultaneously. The
Bio-Pump control local LCD will change to:
2. Press the checkmark to confirm “Enable Emergency Mode.” When pressed, the
following will also occur:
■ system alarms will become disabled
■ the system status LED will alternately flash between yellow and red
Warning: When the Emergency Mode is enabled, all safety systems are disabled.
Warning: Closely monitor the perfusion circuit for changes in resistance to flow,
indications of backflow, and introduction of air into either the venous circuit or the
arterial circuit.
3. Press the top arrow to scroll and select the desired parameter to monitor in the
upper half of the LCD.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Troubleshooting
4. Press the bottom arrow to scroll and select the desired parameter to monitor in
the lower half of the LCD.
5. To disable the Emergency Mode, press both scroll arrows simultaneously.
The LCD will change to:
6. Press the checkmark to confirm “Disable Emergency Mode.”
Bio-Pump Failure
If the Bio-Pump does not spin,
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 7
■ Reset the motor controller by turning the pump speed RPM knob to zero for a
minimum of 1 second.
If the Bio-Pump either fails to start or stops spinning,
■ Clamp the arterial and venous lines to prevent backflow.
■ Remove the Bio-Pump pumphead from the remote drive motor.
■ Attach the handcrank adapter plate to the face of the remote drive motor.
■ Attach the Bio-Pump pumphead to the magnetic coupling on the handcrank.
■ Turn the handcrank in the direction of the yellow arrows on the case of the
handcrank to spin the Bio-Pump pumphead.
Note: If the handle is turned in the opposite direction of the arrows, the centrifugal
pump still pumps fluid through the outlet, but the efficiency is reduced and the
LED display does not illuminate.
■ Remove the clamps from the venous and arterial lines to resume blood flow.
Roller Pump Failure

Warning: Closely monitor the operation of the roller pumps for unexpected
interruption of normal function.
If a roller pump unexpectedly stops:
■ Determine if a safety system event occurred that is linked to the roller pump that
is configured to Stop.
Note: Check the Events Log Secondary Screen for discrete or multiple events that
could result in a roller pump Stop response.
■ Check the pump display to see if the flow/RPM value is flashing. If it is flashing,
press the Start/Stop button to restart the pump.
■ Check the top line of the message bar for a roller pump failure message.
PM1 PUMP NOT RUNNING
■ This alarm will be accompanied with the system status LED changing to red, the
message bar changing to red, and the sounding of audible alarm tones.
■ Press , then press to reset the alarm. Resume roller pump operation.
■ If the problem persists, prepare a backup roller pump.
If a backup roller pump is available, and there is a sufficient length of tubing in the
circuit, clamp the tubing, remove the tubing segment in the pump raceway, and install
to a different roller pump that will accommodate the size of tubing.
Warning: Always ensure proper direction of rotation before starting a backup roller
pump and also ensure 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.
If a backup roller pump is not available:
■ lift the roller pump safety cover
■ unlatch the integrated handcrank
■ grasp the black knob and manually rotate the pump clockwise
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Troubleshooting
Note: The rollers in the roller inserts are installed with one-way bearings to prevent
inadvertent reverse handcranking. When tubing is installed in the pump raceway, the
rotation of the pump will only occur in a clockwise direction.
Warning: 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.
If a roller pump unexpectedly continues running after rotating the pump speed RPM
knob fully counterclockwise or pressing the Start/Stop button:
■ Immediately check the top line of the message bar for a roller pump failure
message.
PM1 PUMP FAILED TO STOP
■ This alarm will be accompanied with the system status LED changing to red, the
message bar changing to red, and the sounding of audible alarm tones.
■ Press , then press to reset the alarm.
■ If the roller pump continues running, carefully open the safety cover to activate the
cover interlock.
■ If the roller pump continues running, clamp the tubing at the pump inlet. Contact
a Medtronic service representative.
Bio-Pump Backflow Detected

■ the alert “BIO-PUMP BACKFLOW” appears in the top line of the message bar
■ the sounding of audible alert tones
Warning: The Bio-Pump backflow alert indicates backflow. When using gravity
drainage, air may enter the arterial cannula. Before resuming antegrade flow, clamp
the arterial line and check for air. Thoroughly remove all visible air before resuming
bypass.
User Interventions:
■ Clamp the arterial line.
■ Check the status of the Bio-Pump to ensure it has not unexpectedly stopped.
Increase Bio-Pump speed as required to overcome patient arterial resistance.
■ Check to ensure the Bio-Pump has not decoupled from the remote drive motor.
■ Check the arrow on the ultrasonic flow sensor to ensure it is consistent with the
forward direction of arterial flow. If necessary, replace the flow sensor.
■ Increase pump speed sufficient to overcome circuit resistance and then slowly
unclamp the arterial line. Confirm antegrade flow.
AAR Controller Failure (Resting Heart mode only)

A failure mode with the AAR Controller will generate an alarm condition and:
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 7
Alarms
■ the top line of the message bar will display the failure mode of the AAR Controller
User Interventions:
VARD: PINCH VALVE NOT CLOSED
■ Immediately clamp the VARD purge line to prevent excess blood being removed
from the circuit.
■ If the pinch valve remains open, closely monitor the top of the VARD for any
accumulation of air. Release the clamp on the VARD purge line as required to
evacuate air from the VARD without causing excess blood loss.
VARD: PINCH VALVE NOT OPEN
■ Press . This will cause the pinch valve to open for 0.5 second and then close.
■ If the pinch valve fails to open, press the Mechanical button on top of the pinch
valve to evacuate air from the VARD.
Alarms
This section includes a list of the conditions that could occur with the system and
generate an ALARM during a procedure.
The following describes the details for each Alarm.
Message: The display of the Alarm condition that appears in the top line of the Message
Bar of the CID.
Cause: The description or explanation of the main cause for the Alarm.
Resolution: Describes the recommended interventions by the user to remove the alarm
condition.
Message Cause Resolution

AP01: CONTROL SYSTEM The control system generates a Reset the alarm. If the problem
NOT RUNNING 'life' signal with a specific time persists, activate the
shape that informs the protective emergency mode to proceed
system about its correct with the procedure and contact
functioning and time-base. The a service technician.
alarm is activated in case of a
'control life' failure detected by the
protective processor (after 3
seconds of missing or incorrect
detection of the 'control life' signal).
AP02: USER INTERFACE Failure of the User Interface Reset the alarm. If the problem
SYSTEM NOT RUNNING processor detected by the persists, activate the
protective processor (after 15 emergency mode to proceed
seconds of missing or incorrect with the procedure and contact
User Interface communication). a service technician.
AB21: CPB VOLTAGE OUT OF CPB voltage is out of [4.75 … 5.30] Reset the alarm. If the problem
RANGE Volt. persists, activate the
emergency mode to proceed
with the procedure and contact
a service technician.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Troubleshooting
Alarms

AB22: CPB CONTROL The alarm is activated after 5 Reset the alarm. If the problem
COMMUNICATION FAILURE seconds of absent or incorrect persists, activate the
data reception from the control emergency mode to proceed
processor via the BCL link. with the procedure and contact
AB23: CPB FLOW METER The flow meter module provides Reset the alarm. If the problem
COMMUNICATION FAILURE real blood flow data via a persists, activate the
dedicated serial link. The alarm is emergency mode to proceed
activated when a failure in the data with the procedure and contact
acquisition from the flow meter is a service technician.
found (after 6 consecutive
communication errors).
AB24: CPB VLP ACQUISITION VLP reading error from dedicated Reset the alarm. If the problem
FAILURE acquisition driver. persists, activate the
AB25: CPB ALP ACQUISITION ALP reading error from dedicated Reset the alarm. If the problem
FAILURE acquisition driver. persists, activate the
AB26: CPB RPM DEVIATION Error between the measured RPM Reset the alarm. If the problem
ERROR and the setting value is higher than persists, activate the
the maximum between 20% and emergency mode to proceed
500 RPM. with the procedure and contact
A041: BCL COMMUNICATION The alarm is activated after 5 Reset the alarm. If the problem
FAILURE seconds of absent or incorrect persists, activate the
data reception from the CPB via emergency mode to proceed
the BCL link. with the procedure and contact
A042: PROTECTIVE SYSTEM The protective system generates a Reset the alarm. If the problem
NOT RUNNING 'life' signal with a specific time persists, activate the
shape that informs the control emergency mode to proceed
system about its correct with the procedure and contact
functioning and time-base. The a service technician.
alarm is activated in case of a
'protective life' failure detected by
the control processor (after 3
seconds of missing or incorrect
detection of the 'protective life'
signal).
A043: USER INTERFACE Failure of the User Interface Reset the alarm. If the problem
SYSTEM NOT RUNNING processor detected by the control persists, activate the
processor (after 15 seconds of emergency mode to proceed
missing or incorrect User Interface with the procedure and contact
communication). a service technician.
A044: HTS MODULE The HTS module provides data Reset the alarm. If the problem
COMMUNICATION FAILURE from the insulated sensors persists, activate the
(temperatures, oxygen saturation emergency mode to proceed
and hematocrit) to the control with the procedure and contact
system via the dedicated serial a service technician.
link. The alarm is activated in case
of a failure in the data acquisition
from the HTS (after 5 consecutive
communication errors).
A045: POWER SUPPLY Power supply failure: Main present Reset the alarm. If the problem
FAILURE and 24 Volt absent. persists, activate the
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8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 7
Alarms

A046: UPS FUSES FAILURE UPS fuse failure in main power Reset the alarm. If the problem
mode. persists, activate the
A047: INCORRECT UPS UPS mode failure: battery mode in Reset the alarm. If the problem
MODE presence of main power and persists, activate the
opposite situation. emergency mode to proceed
A048: CONTROL VOLTAGE Control voltage is out of [4.75 … Reset the alarm. If the problem
OUT OF RANGE 5.30] Volt. persists, activate the
A049: PROTECTIVE VOLTAGE Protective voltage out of [4.75 … Reset the alarm. If the problem
OUT OF RANGE 5.30] Volt. persists, activate the
A050: DIFFERENT Control and protection systems Reset the alarm. If the problem
CONTROL/PROTECTIVE have non-congruent functioning persists, activate the
MODE modes. emergency mode to proceed
A051: DIFFERENT The alarm is activated in case of Reset the alarm. If the problem
CONTROL/PROT. THERAPY different control and protective persists, activate the
therapies. emergency mode to proceed
A052: DIFFERENT Control and protection system Reset the alarm. If the problem
CONTROL/PROT. STATE detect two different functioning persists, activate the
statuses. emergency mode to proceed
A053: DIFFERENT VLP AND The absolute difference between Reset the alarm. If the problem
PR5 PRESSURES VLP (pressure managed by CPB persists, activate the
processor) and PR5 (pressure emergency mode to proceed
managed by control processor) is with the procedure and contact
higher than 35 mm Hg for 10 a service technician.
seconds.
Possible causes:
■ calibration problem
■ possible transducer failure
A054: DIFFERENT ALP AND The absolute difference between Reset the alarm. If the problem
PR6 PRESSURES ALP (pressure managed by CPB persists, activate the
processor) and PR6 (pressure emergency mode to proceed
managed by control processor) is with the procedure and contact
higher than 35 mm Hg for 10 a service technician.
seconds.
Possible causes:
■ calibration problem
■ possible transducer failure
LOW BATTERY ■ Battery mode charge has If possible, arrange the

fallen under 55%. patient's disconnection.
A056: UPS FAILURE Failure of the UPS Reset the alarm. If the problem
(Uninterruptable Power Supply) persists, activate the
Board. emergency mode to proceed
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Troubleshooting
Alarms

A121: PM1 PUMP DRIVER Failure of the PM1 roller pump Reset the alarm. If the problem
FAILURE electronic driver detected by the persists, activate the
'PM1-TFO' signal. emergency mode to proceed
A122: EXCESSIVE CURRENT The alarm is activated in case of Reset the alarm. If the problem
ON PM1 PUMP excessive current of the motor persists, activate the
provided by ‘PM1-SEN’ signal, for emergency mode to proceed
preventing overheating or burning with the procedure and contact
of the coil. a service technician.
A124: PM1 PUMP FAILED TO The encoder detects the PM1 Reset the alarm. If the problem
STOP pump running when it should be persists, activate the
stopped. emergency mode to proceed
A125: PM1 PUMP NOT The encoder does not detect PM1 Reset the alarm. If the problem
RUNNING pump rotation when it should be persists, activate the
running. emergency mode to proceed
A127: PM1 ROTOR BLOCKED The rotation sensor does not ■ Correctly insert the rotor in
detect PM1 rotor movement when its site.
it should be running. ■ Replace the rotor.
Possible causes: ■ If the problem persists,
■ the rotor is not inserted in its turn off the pump and
site contact a service
■ the rotation sensors are technician.
demagnetized
demagnetized
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 7
Alarms

STOP pump running when it is should be persists, activate the
demagnetized
demagnetized
A162: CPG AIR SENSOR The alarm is activated in therapy Reset the alarm. If the problem
SELF-TEST FAILED when CPG air sensor self-test persists, contact a service
fails. technician.
ABD CABLE NOT ■ Bio-Pump running. Connect ABD cable.

CONNECTED ■ ABD cable disconnected.
AIR DETECTED BY ABD ■ ABD air sensor is enabled. See detailed procedure in this
■ ABD air sensor detects air. chapter.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Troubleshooting
Alarms

AIR IN CARDIOPLEGIA ■ CPG air sensor is enabled. See detailed procedure in this
CIRCUIT ■ CPG air sensor detects air. chapter.
OVERPRESSURE: ALP ALP pressure is greater than the Correct overpressure condition
corresponding alarm limit. and restart pumps (Bio-Pump
and/or roller pumps) if stopped.
BIO-PUMP EXCESSIVE STOP The Bio-Pump has remained still Restart the Bio-Pump.
for more than 60 seconds (the
alarm is active only if the pump
timer is running).
LOW BATTERY Remaining charge time is 05:00.
OVERPRESSURE: PR1 PR1 pressure is greater than the Correct overpressure condition
OVERPRESSURE: PR7 PR7 pressure is greater the Correct overpressure condition

TOO MUCH AIR IN VARD: ■ VARD Auto Mode is enabled. Check venous cannula
CHECK VACUUM ■ VARD servo is enabled. position.
■ Air in VARD (lower sensors) Check security of venous
cannula purse string.
Secure loose connection or luer
fitting on venous line proximal
to the VARD.
VARD: BLOOD BEING ■ VARD Auto Mode is enabled. Determine there is no alert
REMOVED ■ Blood in FIL. The alarm is “AIR IN VARD” or alarm “TOO
activated if, after 3 seconds MUCH AIR IN VARD: CHECK
from blood detection in FIL, VACUUM”
the clamp remains open. Clamp the VARD purge line.
Correct pinch valve if open.
VARD: PINCH VALVE NOT ■ VARD Auto Mode is enabled. Do not press on the Mechanical
CLOSED ■ The pinch valve position button when in the Auto Mode.
sensors detect an 'open' Clamp the VARD purge line.
status when the pinch valve Unclamp the VARD purge line
should be 'closed.' when the system alerts “AIR IN
VARD.”
VARD: PINCH VALVE NOT ■ VARD Auto Mode is enabled. Press on the Mechanical button
OPEN ■ The pinch valve position to open the pinch valve when
sensors detect a 'closed' the system alerts “AIR IN
status when the pinch valve VARD.”
should be 'open.'
VARD: TUBE NOT INSERTED ■ VARD Auto Mode Insert the tubing in the pinch
IN PINCH VALVE ■ Line not inserted in the pinch valve.
valve.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 7
Alarms

OVERPRESSURE: PR5 PR5 (VLP in Resting Heart mode) Correct overpressure condition
pressure is greater than the and restart pumps (Bio-Pump
corresponding alarm limit. and/or roller pumps) if stopped.
LEVEL SENSORS ERROR This alarm condition occurs when: Check the correct positioning of
■ Two-sensor configuration is the two sensors; if the position
selected is correct, the low sensor could
■ level sensing is enabled be damaged.
■ high level sensor sees fluid
■ low level sensor sees air
Possible causes:
■ fluid between high and low
sensor with low and high
sensors in the reverse
position (low sensor above
high sensor)
■ fluid above the high level
sensor but the low sensor
sees air--low sensor could be
damaged
LOW BLOOD LEVEL This alarm condition occurs when See page 7-6.
the fluid level drops below the
position of the red (alarm) sensor
on the reservoir.
AUTOCLAMP NOT CLOSED This alarm condition occurs when See page 7-12.
sensors that detect the position of
the Remote Tube Clamp indicate it
is open when the conditions
maintain it should be closed.
AUTOCLAMP NOT OPEN This alarm condition occurs when See page 7-13.
the sensors that detect the position
of the Remote Tube Clamp
indicate it is closed when the
conditions maintain it should be
open.
AUTOCLAMP CLOSED AND RTC is closed but the ultrasonic See page 7-13.
FLOW STILL PRESENT flow sensor on the arterial line still
detects blood flow when it should
be 0.00 L/min.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Troubleshooting
Alerts
Alerts
This section includes a list of the conditions that could occur with the system and
generate an ALERT during a procedure.
The following describes the details for each Alert.
Message: The display of the Alert condition that appears in the top line of the
Message Bar of the CID.
Description: The description or explanation of the main cause for the Alert.
Message Description
ABD CABLE NOT CONNECTED The flow meter/air bubble detector cable has not
been connected to the system.
ABD OFF Air detected by ABD (with ABD not enabled and
Bio-Pump running).
AIR DETECTED BY ABD Air detected by the ABD (with ABD enabled and
Bio-Pump running).
AIR IN CARDIOPLEGIA CIRCUIT The cardioplegia air sensor is disabled and

detects air.
AIR IN VARD It is activated in one of the following conditions:

■ Standby Mode: air detected in VARD by
lower or upper sensors.
■ Auto Mode: air detected in VARD by upper
sensors.
OVERPRESSURE: ALP ALP pressure is greater than the corresponding

alert limit.
BATTERY MODE The machine is operating in battery mode.
BIO-PUMP: BACKFLOW Bio-Pump negative flow is detected by the flow

meter.
BIO-PUMP: HIGH FLOW VLP servo is activated and the Bio-Pump flow is
greater than 125% of the initial value.
BIO-PUMP: LOW FLOW Bio-Pump flow is lower than the corresponding

“low flow” alert limit and the RPM is greater than
2000.
CARDIOPLEGIA AIR SENSOR DISABLED The cardioplegia air sensor has been disabled by
the user.
DOSE DELIVERED Cardioplegia dose has been delivered.
DRUG FLOW NOT REACHABLE It is activated in case of 2 pumps cardioplegia

(with 3.2 mm (1/8 in) tubing in drug pump) when
the actual cardioplegia flow and ratio setting
determine a drug flow (PM3) greater than 160
mL/min.
EMERGENCY MODE: ALL ALARMS DISABLED Emergency mode activated by the user; all the
alarms and alerts are disabled.
HEMATOCRIT: LOW VALUE Hematocrit value is lower than 20% and pump
time is running.
HIGH ARTERIAL (T1) TEMPERATURE Arterial temperature (probe connected to T1

inlet) is greater than 43.0°C
HIGH VENOUS (T2) TEMPERATURE Venous temperature (probe connected to T2

A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 7
Alerts
Message Description
HIGH CARDIOPLEGIA (T3) TEMPERATURE Cardioplegia temperature (probe connected to T3
HIGH T4 TEMPERATURE Temperature probe connected to T4 inlet is

greater than 43.0°C




LOADING/UNLOADING PM1 PUMP SEGMENT Automatic tube loading/unloading feature

activated for the PM1 pump.



LOW BATTERY Remaining battery charge is 10 minutes.
NEXT CARDIOPLEGIA DOSE IS DUE The time to next dose is elapsed and the clamp
time is running.
OXYGEN SATURATION: LOW VALUE Oxygen saturation value is lower than 50% and
pump time is running.
OVERPRESSURE: PR1 PR1 pressure is greater than the corresponding

alert limit.

alert limit.

alert limit.

alert limit.

alert limit.

alert limit.
PM1 PUMP COVER OPEN PM1 pump cover is open.
TOO MUCH AIR IN VARD: CHECK VACUUM Activated only in Auto Mode if air is detected in
the VARD lower sensors and VARD Servo is
enable.
VARD: CABLE NOT CONNECTED VARD cable not connected.
VARD: LOW SUCTION VARD Pressure (PR7) is less negative than -200
mm Hg.
VARD: STAND-BY MODE VARD in Standby Mode.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Troubleshooting
Alerts
Message Description
VARD: TUBE NOT INSERTED IN PINCH VALVE The system is not detecting the silastic tube in
the pinch valve.
OVERPRESSURE: PR5 PR5 (VLP in Resting Heart mode) pressure is

greater than the corresponding alert limit.
LEVEL SENSING DISABLED This alert condition occurs when:

■ 1 or 2 level sensor configuration is selected
■ level sensing is disabled
LEVEL SENSORS ERROR This alert condition occurs when:

■ two-sensor configuration is selected
■ level sensing is disabled
■ high level sensor sees fluid
■ low level sensor sees air
The cause of the problem could be:
■ fluid between high and low sensor WITH low
and high sensor in the reverse position (low
sensor above high sensor)
■ fluid above the high level sensor but the low
sensor sees air--low sensor could be
damaged
LOW BLOOD LEVEL This alert condition occurs when the fluid level
drops below the position of the yellow (alert)
sensor on the reservoir.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 7
Alerts
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Warranty 8
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 8
IMPORTANT NOTICE - LIMITED WARRANTY
(U.S. Customers Only)

MEDTRONIC, INC. INSTRUMENT LIMITED WARRANTY1 (U.S.)
A. This LIMITED WARRANTY provides the following assurance to the purchaser of
the Medtronic® Performer™ CPB Advanced Extracorporeal Circulatory
Support System, hereafter referred to as the “Instrument”:
(1) Should the Instrument fail to function within normal tolerances due to a defect
in materials or workmanship within a period of one (1) year, commencing with
the delivery of the Instrument to the purchaser, Medtronic will at its option:
(a) repair or replace any defective part or parts of the Instrument; (b) issue a
credit to the purchaser equal to the Purchase Price, as defined in Subsection
A (2), against the purchase of the replacement Instrument; or (c) provide a
functionally comparable replacement Instrument at no charge.
(2) As used herein, Purchase Price shall mean the lesser of the net invoiced
price of the original, or current functionally comparable, or replacement
Instrument.
B. To qualify for the repair, replacement or credit set forth in Section A, the following
conditions must be met:
(1) The Instrument must be returned to Medtronic within sixty (60) days after
discovery of the defect (Medtronic may, at its option, repair the Instrument on
site).
(2) All installation, updates, modifications, and repairs to the Instrument must
have been performed only by personnel authorized by Medtronic.
(3) The Instrument must have been serviced, repaired, altered, or its internal
components accessed only by persons or entities authorized by Medtronic to
perform such work on the Instrument.
(4) The Instrument must have been (i) operated only by personnel who have
been properly trained in operation of the Instrument, (ii) operated only in
accordance with the instructions given in the Operator's Manual for the
Instrument, and (iii) subject to no misuse, abuse or accident.
C. This LIMITED WARRANTY is limited to its express terms. In particular:
(1) Except as expressly provided by this LIMITED WARRANTY, MEDTRONIC IS
NOT RESPONSIBLE FOR ANY DIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT, FAILURE OR
MALFUNCTION OF THE INSTRUMENT, WHETHER THE CLAIM IS BASED
ON WARRANTY, CONTRACT, TORT OR OTHERWISE.
(2) This LIMITED WARRANTY is made only to the purchaser of the Instrument.
AS TO ALL OTHERS, MEDTRONIC MAKES NO WARRANTY, EXPRESS
OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED
WARRANTY OF MERCHANTABILITY, OR FITNESS FOR A PARTICULAR
PURPOSE WHETHER ARISING FROM STATUTE, COMMON LAW,
CUSTOM OR OTHERWISE. NO EXPRESS OR IMPLIED WARRANTY TO
THE PATIENT SHALL EXTEND BEYOND THE PERIOD SPECIFIED IN A(1)
ABOVE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE REMEDY
AVAILABLE TO ANY PERSON.
1 This Limited Warranty is provided by Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN
55432-5604. It applies only in the United States. Areas outside the United States should contact their
local Medtronic® representative for exact terms of the Limited Warranty.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Warranty
(3) The exclusions and limitations set out above are not intended to, and should
not be construed so as to contravene mandatory provisions of applicable law.
If any part or term of this LIMITED WARRANTY is held to be illegal,
unenforceable or in conflict with applicable law by a court of competent
jurisdiction, the validity of the remaining portions of the LIMITED WARRANTY
shall not be affected, and all rights and obligations shall be construed and
enforced as if this LIMITED WARRANTY did not contain the particular part or
term held to be invalid. This LIMITED WARRANTY gives the purchaser
specific legal rights. The purchaser may also have other rights which vary
from state to state.
(4) No person has any authority to bind Medtronic to any representation,
condition or warranty except this Limited Warranty.
(For Countries Outside the U.S.)

THE FOLLOWING LIMITED WARRANTY APPLIES TO CUSTOMERS OUTSIDE
THE UNITED STATES.
A. This LIMITED WARRANTY provides the following assurance to the purchaser of
the Medtronic® Performer™ CPB Advanced Extracorporeal Circulatory
Support System, hereafter referred to as the “Equipment” that should the
Equipment fail to function within normal tolerances due to a defect in materials or
workmanship within a period of one (1) year commencing with the delivery of the
Equipment to the purchaser, Medtronic will at its option: (a) repair or replace any
defective part or parts of the Equipment; (b) issue a credit equal to the original
Equipment purchase price (but not to exceed the value of the replacement
Equipment), against the purchase of replacement Equipment, or (c) provide
functionally comparable replacement Equipment at no charge.
B. To qualify for this repair, replacement or credit set forth in Section A, the following
conditions must be met:
(1) The Equipment must be returned to Medtronic within sixty (60) days after
discovery of the defect, (Medtronic may, at its option, repair the Equipment on
site).
(2) All installation, updates, modifications, and repairs to the Equipment must
have been performed only by personnel authorized by Medtronic.
(3) The Equipment must have been serviced, repaired, altered, or its internal
components accessed only by persons or entities authorized by Medtronic to
perform such work on the Equipment.
(4) The Equipment must have been (i) operated only by personnel who have
been properly trained in operation of the Equipment, (ii) operated only in
accordance with the instructions given in the Operator's Manual for the
Equipment, and (iii) subject to no misuse, abuse or accident.
C. This LIMITED WARRANTY is limited to its express terms. In particular, Medtronic
is not responsible for any incidental or consequential damages based on any use,
defect or failure of the Equipment, whether the claim is based on warranty,
contract, tort or otherwise.
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Chapter 8
D. The exclusions and limitations set out above are not intended to, and should not
be construed so as to, contravene mandatory provisions of applicable law. If any
part or term of this LIMITED WARRANTY is held by any court of competent
jurisdiction to be illegal, unenforceable or in conflict with applicable law, the
validity of the remaining portion of the LIMITED WARRANTY shall not be
affected, and all rights and obligations shall be construed and enforced as if this
LIMITED WARRANTY did not contain the particular part or term held to be
invalid.
E. No person has any authority to bind Medtronic to any representation, condition or
warranty except this Limited Warranty.
A14113002 Rev. 2.0

PerformerV1.5_Rev1IX.fm 3/4/08 3:05 pm Medtronic Confidential
8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Index A
A Loss or Failure 7-15

Warnings 1-7
AAR Controller
Operation 5-60 Bio-Console 1-5
Overview 5-58 Bio-Pump 1-2, 1-3
Run Screen 5-58 Backflow Detected 7-19
Warnings 1-6 Bio-Pump Configuration 5-105
Air Bubble Detection 5-64, 5-65, 7-15 Cautions 1-9
Safety System 7-5 Connection site 5-15
Transducers 5-63 Control Panel 5-3, 5-5
Failure 7-17
Air Bubble Detector 3-4, 5-15, 5-42, 7-4 Indications for Use 1-5
Alerts 7-27 Options Menu Screen 5-94
Warnings 1-8 Pump Speed RPM Knob 5-5, 5-106
Response Definitions 5-27, 5-98
Air Detection 1-3, 5-63
Safety System Events 5-24, 5-97
Alerts and Alarms 5-56
Setup Button 5-38
Warnings 1-5
To Assign Pump Responses 5-24
Alarms 5-40, 7-2, 7-20 Warnings 1-8
Cardioplegia Delivery Air Detection Alerts and
Blood Drug Ratio 5-50
Alarms 5-56
High Pressure Condition 5-87 C
Priority of Alarms 7-3
Resetting 7-3 Calibration 2-3
Self-Resetting Alarms 7-4
Simultaneous Activation of Alarms/Alerts 7-2 Cardiac Index 1-4, 5-42, 5-102
VLP 5-106 Cardioplegia
Alerts 5-40, 7-2, 7-27 Circuit and Delivery Parameters 5-53
Cardioplegia Delivery Air Detection Alerts and Delivery 5-54
Alarms 5-56 Delivery Air Detection Alerts and Alarms 5-56
High Pressure Condition 5-87 Dose Settings 5-51
Simultaneous Activation of Alarms/Alerts 7-2 Manual Mode 5-51
VLP 5-106 Time Mode 5-51
Volume Mode 5-51
Arterial Line ABD System 5-63 During Cardioplegia Infusion 5-55
Setup and Operation 5-63 Volume and Time Tracking 5-52
Arterial Line Pressure Sensor 5-14 Castor Brake and Unbrake Switches 5-2
AutoClamp System 3-6, 5-73 Cautions 1-9
Auxiliary Timer 5-48 Central Information Display (CID) 1-2, 1-3, 5-3
Cautions 1-9
B Failure 7-15
Warnings 1-5
Battery 1-4, 2-2, 3-5, 3-11, 5-3, 5-111, 7-15
Disposal 2-4 Clamp Timer
Operator’s Manual A-1
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
Operation 5-46 G
Cleaning 6-2 Grounding
Configuration Equalization Post 5-2
Acoustic Signals 5-30 General Data 3-2
Date and Time 5-32
General Data 5-28
H
Language 5-31 Handcrank 5-7
Password 5-31 Manual Operation 5-8
Pressure Transducers 5-20 Warnings 1-8
Roller Pumps 5-20
Safety Systems 5-21 Hematocrit 1-4, 5-42
Saving Configuration Settings 5-32 Monitoring 1-3, 3-10, 5-90
Service Settings 5-32
Home Button 5-38
Software Version 5-32
Temperature Channels 5-20 HTS Module 3-10, 5-54, 5-90
Console Up and Down Switches 5-2
I
Installation 4-2
D L
Defibrillator
LEMO® Connector 5-60, 5-61
Warnings 1-5
Delivery Mode 5-49 Level Sensing System 3-6, 5-67
One-Pump 5-40, 5-49
M
Selection 5-49
Two-Pump 5-40, 5-49 Main Power Supply
Failure 2-2, 3-11
Description 1-2
Dynamic Function Buttons 5-38 Main Power Switch 5-2
Warnings 1-7
E Main Run Screen 5-41
Emergency Procedures 7-4 Maintenance 6-2
Equipotential Connection 2-4 Manual Mode 5-51, 5-55
Events Log 5-103 Memory Card 5-111
Button 5-38 Install 5-15
Icons 5-103 Warnings 1-5
Screens 5-103
Menu Bar 5-19
External Communication Interface 3-5
Mounting Flanges 5-14
External Devices Connector Panel 5-15
O
F
O2 Saturation 3-10
Flow Display 5-5
Flow Meter 3-4
Connection site 5-15 P
Fluid-In-Line Sensor 3-5, 5-59 Password 5-16, 5-30, 5-31
AAR FIL Sensor 5-14 Configuration 5-31
Protection 5-18
Fuse/Circuit Breakers 5-2
External fuses 3-2 Patient Information 5-100
Replacement 2-3 Button 5-38
Entry of Information 5-100
A-2 Operator’s Manual
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Power Cord 5-2 Time Mode 5-51

Power On Self-Test 5-17 Time Since Last Dose 5-52, 5-55, 5-56
Warnings 1-8
Time to Next Dose 5-52, 5-55, 5-56
Trending 1-4, 5-101
Pressure Transducers 1-4 Parameters and Y-Axis Ranges 5-102
Configuration 5-20 Screens 5-101
Zeroing 5-87
Tube Inserts 5-9
Pressures 3-4 Installing 5-9
Trending 5-101
Tubing 5-11
Preview Buttons 5-50 Loading 5-11
Mechanical Loading Feature 5-13
Printer 3-5, 5-103 Warnings 1-8
Printed Report 5-104
Pump Timer U
Operation 5-46 Uninterruptible Power Supply 3-5, 3-11
Overview 5-46 Warnings 1-5
R User Interface 5-64
Setup 5-64
Read-Only Screen Graphics 5-37
Roller Insert 5-7 V
Installing 5-7 VARD 1-4
Removing 5-7 Operation 5-60
Setting the Roller Pump Speed 5-7 Overview 5-58
Roller Pumps 5-3, 5-6 Run Screen 5-58
Control Panel 5-3 Venous Line Pressure Sensor 5-14
PM1 1-2, 3-3, 5-3
PM2 1-2, 3-3, 5-4 Venous Line Pressure Servo 5-104
PM3 1-2, 3-3, 5-4 Activating 5-105
PM4 1-2, 3-4 Alert and Alarm Conditions 5-106
Response Definitions 5-27, 5-98
Setup 5-95 Volume Mode 5-51
Warnings 1-8 Volume Tracking 5-50
S W
Safety Standards 2-2 Warnings 1-5
Safety System 5-96 Warranty 8-2
Assigning Pump Responses 5-24
Configuration 5-21
Configuration Edit Screens 5-96
Start Timers 5-46
Static Function Buttons 5-19, 5-37
Stop Timers 5-47
T
Temperature 5-100
Monitoring 1-3, 5-42, 5-54
Trending 5-101
Time Between Doses 5-55
Operator’s Manual A-3
A14113002 Rev. 2.0

8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS0023
A-4 Operator’s Manual
A14113002 Rev. 2.0

PerformerV1.5_bcv.fm 3/4/08 3:05 pm Medtronic Confidential
8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
A14113002 Rev. 2.0

PerformerV1.5_bcv.fm 3/4/08 3:05 pm Medtronic Confidential
8.5 in x 11.0 in (215.9 mm x 279.4 mm) CS017
Manufacturer Asia
RanD S.r.l. Medtronic International Ltd.
Via Statale 12, 62 Suite 1602 16/F, Manulife Plaza
41036 Medolla (MO) Italy The Lee Gardens, 33 Hysan Avenue
Internet: www.rand-biotech.com Causeway Bay
Tel. 39-0535-49283 Hong Kong
Fax 39-0535-660636 Tel. 852-2891-4068
Fax 852-2591-0313
Europe
Americas
Europe/Africa/Middle East
Headquarters Latin America
Medtronic International Trading Sàrl Medtronic Latin America
Route du Molliau 31 3750 NW 87th Avenue
Case Postale 84 Suite 700
CH-1131 Tolochenaz Miami, FL 33178
Switzerland Tel. 305-500-9328
Internet: www.medtronic.co.uk Fax 786-709-4244
Tel. 41-21-802-7000
Fax 41-21-802-7900 Canada
Medtronic of Canada Ltd.
Medtronic E.C. Authorized Representative / 6733 Kitimat Road
Distributed by Mississauga, Ontario L5N 1W3
Medtronic B.V. Tel. 905-826-6020
Earl Bakkenstraat 10 Fax 905-826-6620
6422 PJ Heerlen Toll-free in Canada: 1-800-268-5346
The Netherlands
Tel. 31-45-566-8000 United States
Fax 31-45-566-8668 Medtronic, Inc.
710 Medtronic Parkway
Asia-Pacific Minneapolis, MN 55432-5604
USA
Japan Internet: www.medtronic.com or
Medtronic Japan www.perfusionsystems.com
Comodio Shiodome 5F Tel. 763-391-9000
2-14-1 Higashi-Shimbashi, Minato-ku Fax 763-391-9100
Tokyo 105-0021
Japan
Tel. 81-3-6430-2001
Fax 81-3-6430-7140
Australia
Medtronic Australasia Pty. Ltd.
Business Address:
97 Waterloo Road
North Ryde NSW 2113
Mailing Address:
PO Box 945
North Ryde NSW 1670
Australia
Tel. 61-2-9857-9000
Fax 61-2-9878-5100
*A14113002*
© Medtronic, Inc. 2006, 2008
A14113002 Rev. 2.0
A14113002 Rev. 2.0

A14113002_Rev2_sp.qxd 3/4/2008 3:06 PM Page 1
PERFORMER™ CPB
Part # A14113002 Rev 2.0
A14113002_Rev2_Tabs.qxd 3/4/2008 3:07 PM Page 1
Introduction
All Tabs - Blue PMS 301 A14113002 Rev. 2.0

Do not print die line 1 - for position only
Introduction

Safety

Safety

Specifications
Technical

Specifications
Technical

Installation

Installation

Instructions
for Use

Instructions
for Use

Maintenance
Cleaning and

Maintenance
Cleaning and

Troubleshooting

Troubleshooting

Warranty

Warranty

Index

Index


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PERFORMER™ CPB

Explanation of symbols on package labeling

For US Audiences Only

Fragile, Handle with Care

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

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

Remote Tube Clamp

A14113002 Rev. 2.0

Class II (Double Insulated) Equipment

Warning, Crushing Hazard: Finger

Pneumatic Pressure Range

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Operator’s Manual iii

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

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System Description 1-2

System Overview 1-2

Indications for Use 1-5

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The Performer™ CPB System, hereafter referred to as the Performer CPB, is an

Total extracorporeal support of the cardiovascular system is accomplished by using

1-2 Operator’s Manual

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Temperature monitoring using YSI™1 Series 400 probes for 8 temperatures

1 YSI™ is a registered trademark of YSI Incorporated.

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1-4 Operator’s Manual

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Indications for Use

The Medtronic® Performer™ CPB Advanced Extracorporeal Circulatory Support

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Main Power Switch

Central Information Display (CID)

3 CompactFlash® is a registered trademark of SanDisk Corporation.

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■ Using the Pre-Cardiopulmonary Bypass Parameters Screen with the

Power On Self-Test (POST)

Air Bubble Detector (ABD)

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4 FORANE® is a registered trademark of ATOFINA.

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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

Technical Documentation 2-3

Replacing Fuses 2-3

Equipotential Connection 2-4

Battery Pack Disposal 2-4