Medtronic R5400022 Operator's Manual
PERFORMER™CPB
c
PERFORMER™CPB
An Advanced Extracorporeal Circulatory Support System
Operator’s Manual
Distributed Exclusively
by Medtronic, Inc.
Manufactured by
RanD S.r.l.
Medolla (MO) Italy
c
Explanation of symbols on package labeling
Refer to the package label to see which symbols apply to this product
0123
Conformité Européenne (European Conformity). This symbol means that the device fully
complies with European Council Directive MDD 93/42/EEC (14 June 1993, concerning
medical devices) and amendments.
Caution, Consult Accompanying Documents
Serial Number
Lot Number
Quantity
For US Audiences Only
Date of Manufacture
Temperature Limitation
Humidity Limitation
Catalog Number
Manufacturer
Fuse
Alternating Current
Type BF Equipment
High Voltage
Medical equipment with respect to electrical shock fire, and mechanical hazards only in
accordance with UL 60601-1/CAN/CSA C22.2 No. 601.1, IEC 60601-2-16 71NL.
This Way Up
Fragile, Handle with Care
xx Kg
MAX
Maximum Weight
Do not dispose of this product in the unsorted municipal waste stream.
Danger: Risk of explosion if used in the presence of flammable anesthetics.
Equipotentiality
Level Sensor
Remote Tube Clamp
VARD
Operator’s Manual i
Bio-Pump
Flowmeter/ABD
Class II (Double Insulated) Equipment
Open Here
Warning, Crushing Hazard: Finger
Pneumatic Pressure Range
Atmospheric Limitation
ii Operator’s Manual
Table of Contents
1 Introduction 1-1
System Description 1-2
System Overview 1-2
Indications for Use 1-5
Contraindications 1-5
Warnings 1-5
Cautions 1-9
2Safety2-1
Safety Standards 2-2
Disposables and Accessories 2-2
Main Power Supply Failure 2-2
Electromagnetic Disturbance 2-3
Elimination of the Disposable Material 2-3
End of Life Disposition 2-3
Calibration 2-3
Technical Documentation 2-3
Replacing Fuses 2-3
Equipotential Connection 2-4
Battery Pack Disposal 2-4
3 Technical Specifications 3-1
General Data 3-2
Technical Features 3-3
Electromagnetic Emissions and Immunity Declarations 3-6
Monitoring System for Hematocrit, Temperature and O
Temperature Probes 3-11
Battery Supply System (UPS) 3-11
IEC 60601-2-16 Compliance Chart 3-12
Saturation 3-10
2
4 Installation 4-1
Installation 4-2
Installation Checklist and Commissioning 4-3
5 Instructions for Use 5-1
Console 5-2
Roller Pump, Roller Inserts, Tube Inserts, and Tubing 5-6
System Configuration 5-16
System Start-up 5-35
Main Run Screen 5-41
Timers 5-46
Cardioplegia 5-49
AAR Controller - Venous Air Removal Device (Resting Heart mode only) 5-58
Air Detection 5-63
Operator’s Manual iii
Table of Contents
Level Sensing System (Bio-Pump CPB mode only) 5-67
AutoClamp System (Bio-Pump CPB mode only) 5-73
Pressure Mode Selection 5-84
Venous Saturation and Hematocrit Monitoring 5-90
Options Menu Screen 5-94
Servo (Resting Heart mode only) 5-104
Preparing for Cardiopulmonary Bypass Checklist 5-109
Initiating Extracorporeal Support Checklist 5-112
6 Cleaning and Maintenance 6-1
Cleaning 6-2
Maintenance 6-2
7 Troubleshooting 7-1
General Information 7-2
Emergency Procedures 7-4
Alarms 7-20
Alerts 7-27
8 Warranty 8-1
IMPORTANT NOTICE - LIMITED WARRANTY 8-2
IMPORTANT NOTICE - LIMITED WARRANTY 8-3
A Index A-1
iv Operator’s Manual
PERFORMER™ CPB 0
Operator’s Manual
System Description 1-2
System Overview 1-2
Indications for Use 1-5
Contraindications 1-5
Warnings 1-5
Cautions 1-9
Introduction
1
1
Operator’s Manual 1-1
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
Blood Pump, hereafter referred to as the Bio-Pump.
System Overview
®
Bio-Pump® Centrifugal
Total extracorporeal support of the cardiovascular system is accomplished by using
the Bio-Pump
Performer CPB for generating arterial flow up to 10.0 liters per minute (L/min).
Bio-Pump flow is achieved by adjusting the pump speed RPM knob on the front panel
of the Performer CPB console. Flow measurement is accomplished using a reusable
ultrasonic flow transducer that is noninvasively attached to the arterial line of the
extracorporeal circuit. The detected flow is displayed on the front panel of the console
(red LED) and on the Main Run Screen of the Central Information Display (CID). The
pump speed RPM knob has a minimum RPM mechanical stop, or detent, that
prevents an unintentional reduction of RPM below 2000. The user must press down
on the detent lever while turning the knob counterclockwise to purposefully reduce the
RPM below 2000. The minimum RPM detent lever does not affect increasing the
RPM.
Integral to the Performer CPB are four roller pumps, each with an independent
Start/Stop button, a 3-turn roller speed control knob and a LCD for monitoring flow or
RPM. The roller pumps are indicated for moving fluids through an extracorporeal
circuit that incorporates a flexible tube. The roller pumps are not indicated for use in
supporting flow through arterial circuits.
Two small roller pumps (PM4 and PM3) generate low flow for cardioplegia delivery,
hemoconcentration, or other auxiliary applications. PM4 is a deep-well pump capable
of accommodating two tubes of same or different dimensions and is capable of a
maximum flow of 1.1 L/min. PM3 accommodates one tube and is capable of a
maximum flow of 0.6 L/min. PM3 and PM4 can be configured via the CID so that both
pumps operate in tandem, with PM4 designated as the master pump and PM3
designated as the slave pump. The master pump Start/Stop button and pump speed
RPM knob operate both pumps.
®
Centrifugal Blood Pump. The Bio-Pump is the exclusive device on the
Two large roller pumps (PM1 and PM2) generate flow for cardiotomy suction, left heart
venting, or auxiliary application. PM1 is a low torque/high speed roller pump with a
maximum flow capacity of 3.7 L/min. PM2 is a high torque/mid-flow roller pump with
a maximum flow capacity of 1.5 L/min.
The interchangeable roller pump inserts are factory calibrated for providing optimal
occlusion for standard sizes of polyvinyl chloride (PVC) tubing available for medical
use. Factory-calibrated roller pump inserts are also available when using 2 tubes in a
single raceway.
The Performer CPB provides perfusion monitoring via:
1-2 Operator’s Manual
Pressure monitoring transducers for up to 8 pressures including venous line,
arterial line, cardioplegia delivery, AAR suction, vent line, sucker line, syringe, and
one user-defined.
Introduction
System Overview
Temperature monitoring using YSI™1 Series 400 probes for 8 temperatures
including venous line, arterial line, cardioplegia delivery, and the remainder user
defined.
Flow monitoring for the arterial line using a reusable Transonic
™2
ultrasonic flow
probe, which noninvasively connects directly to the arterial line tubing. This flow
probe also serves to detect backflow in the arterial circuit. Flow data combined
with patient body surface area entered in the CID also provides for continuous
monitoring of cardiac index.
Oxygen saturation and hematocrit monitoring using an opto-electric sensor,
which couples with a dedicated disposable cuvette that is integrated into the
extracorporeal circuit. This data, in combination with the information obtained
from the flow transducer, is used to calculate and display oxygen consumption on
the CID.
Timers for pump time, clamp time, and cardioplegia delivery times and intervals.
The CID enables the user to interact with the Performer CPB equipment. It consists
of a 30.73 cm (12.1 in) color graphic display (256 colors, 800 x 600 pixel) in
combination with a touch screen system to activate the various functions represented
on the screen. The display is divided into well-defined zones for the individual
perfusion modes and uses unique graphic pictures and icons to display information.
Critical information areas are always visible. The touch screen display allows the
user to:
■
display all desired perfusion parameters
■
input patient information
■
configure pump responses to activation of safety devices and events that occur
during bypass
■
set safety alert and alarm limits
■
display graphical trending of data
■
select cardioplegia delivery modes
■
read message alarms and warnings
■
select audible alert and alarm tones
The CID and the console incorporate distinct visual and audible cues intended to
elevate the user's awareness when a safety sensor is activated and when
user-defined or default operational limits of a system are exceeded. The Performer
CPB enables the user to configure integrated safety links between the following safety
sensors and the Bio-Pump and the roller pumps:
■
Air Bubble Detection (ABD) of macro-air in the arterial circuit is integral to the
ultrasonic flow monitoring system. The system can be configured by the user to
cause the Bio-Pump to either Stop or Coast in response to this sensor being
activated and prevent transmission of air to the patient. The user can also
configure this safety link to not change the Bio-Pump function, but only produce
visual and audible alarm cues.
■
Air bubble detection of macro-air in the cardioplegia circuit, using an ultrasonic
transducer mounted to the side of the console that couples directly to the
cardioplegia delivery tubing. The user can configure the cardioplegia delivery
pump (PM4) to either Stop or Pause in response to this event and prevent
transmission of air to the heart. The user can also configure this safety link to not
change the roller pump function but only produce visual and audible alarm cues.
1
YSI™ is a registered trademark of YSI Incorporated.
2
Transonic™ is a registered trademark of Transonic Systems Inc. Corporation.
Operator’s Manual 1-3
Chapter 1
System Overview
■
Active Air Removal (AAR) technology integral to the Performer CPB is used in
conjunction with a dedicated disposable Venous Air Removal Device (VARD) for
venous air sensing and automatic removal. This prevents air entering the venous
line from reaching the Bio-Pump and potentially being transmitted to the patient.
The Active Air Removal (AAR) technology with the VARD is only utilized when
operating the Resting Heart mode.
■
Level Detection utilizes a pair of level sensors to monitor changes in fluid or blood
volume in reservoirs. The system can be configured by the user to cause the
Bio-Pump to either Stop or Coast in response to a level sensor being activated,
preventing emptying the reservoir and transmitting air into the circuit. The user
can also configure this safety link to not change the Bio-Pump function, but only
produce visual and audible alarm cues. The level detection system is only utilized
when operating in the Bio-Pump CPB mode.
■
An AutoClamp System utilizes a pneumatically-powered Remote Tube Clamp
(RTC) that is placed on the arterial line and serves to prevent retrograde flow from
the aorta into the venous reservoir if the Bio-Pump run mode changes. When the
Bio-Pump enters either the STOP or COAST mode, or the pump speed is
manually reduced to 2000 RPM, there exists the potential for arterial retrograde
flow and entrainment of air into the arterial line from around the aortic cannulation
site. This poses a hazard to the patient if the pump is restarted before air is
removed. The AutoClamp System can be configured to automatically clamp the
arterial line when the Bio-Pump speed changes, prevent retrograde flow and
thereby prevent the potential to entrainment air around the aortic cannulation site.
The AutoClamp System is only utilized when operating in the Bio-Pump CPB
mode.
■
Pressure transducers enable user-defined alert and alarm limits for arterial line
pressures, venous line pressures, cardioplegia pressures, as well as the
individual roller pump pressures.
The Performer CPB provides an uninterruptible power supply (UPS) that will provide
battery power to operate the system for a minimum of 30 minutes with a fully loaded
system (see page 5-44) in the absence of line power.
Additional user conveniences include:
■
Cardioplegia delivery configuration options to select automatic shut off of the
cardioplegia pump to user-defined volume or time delivery parameters and a
user-defined option for two-pump blood and drug proportioning from 0:1 (pure
drug) to 15:1.
■
Graphic trending of flow, cardiac index, venous saturation, hematocrit, pressure,
and temperature data.
■
Capability to auto-regulate the speed of the Bio-Pump to maintain a desired
venous line pressure. This function is particularly useful when operating the
Medtronic
®
Resting Heart™ System and optimizing the relationship between
blood flow and left heart emptying.
■
An integrated printer to generate hard copy records.
■
A removable data storage card that allows perfusion and system information to be
stored electronically and then later formatted for generating reports.
■
Electric powered height adjustment for optimal operation, transport, and storage.
1-4 Operator’s Manual
Indications for Use
The Medtronic® Performer™ CPB Advanced Extracorporeal Circulatory Support
System is indicated for use up to 6 hours in the extracorporeal circulation of fluids for
cardiopulmonary bypass procedures, when used by a qualified medical professional
who is experienced in the operation of this or similar equipment.
The Bio-Pump
an extracorporeal perfusion circuit for extracorporeal circulatory support for periods
appropriate to cardiopulmonary bypass (up to 6 hours).
Contraindications
The device is not designed, sold, or intended for use except as indicated.
The centrifugal pump is contraindicated for use as a cardiotomy suction device.
Warnings
Introduction
Indications for Use
®
Centrifugal Blood Pump is indicated for use in pumping blood through
General
■
The user must read and understand all information in the Operator's Manual prior
to use. Failure to read and follow all instructions, or failure to observe all stated
warnings, could cause serious injury or death to the patient.
■
Only trained and qualified medical personnel should operate and monitor the
Perfor mer CPB.
■
Use the system and any attached devices according to the manufacturer's
instructions and good medical practice.
■
The system is qualified only for durations appropriate to cardiopulmonary bypass
procedures. It has not been qualified, either through in-vitro, in-vivo, or clinical
studies, for use beyond 6 hours.
■
The Performer CPB enables the user to change the configuration of the default
factory settings. Reconfiguration in regards to how components respond to events
and assurance that users are properly trained to operate the Perfusion Screens
must be appropriately controlled by the user institution. Failure to establish such
controls may result in user error that could result in patient injury or death.
■
Following standard practices for electronic devices, closely monitor the system
when exposure to intense electrical noise or fluctuating line voltage occurs.
Strong electromagnetic fields emitted from other equipment in the operating room
(OR) (internal and external defibrillators, electrocautery devices, etc) or
fluctuations in the alternating current (AC) power line voltage may compromise
performance or damage the equipment.
■
Portable and mobile radio frequency (RF) communication devices may affect the
operation of this system. (See “Electromagnetic Emissions and Immunity
Declarations” on page 3-6.)
■
A standby Bio-Console® Extracorporeal Blood Pumping Console should be
available during cardiopulmonary bypass procedures.
■
Maintain a minimum Bio-Pump speed or clamp the pump outlet line to prevent
backflow.
■
Do not kink the VARD sensor cable.
Operator’s Manual 1-5
Chapter 1
Warnings
■
Do not allow fluids to come into contact with the cable connections.
■
To prevent backflow of the patient's blood when the pump outlet tubing is open,
establish and maintain a minimum pump speed that overcomes line and patient
resistance. Failure to do this could allow retrograde flow and exsanguinate the
patient.
■
All gaseous bubbles have the potential for gaseous emboli and must be dealt with
carefully. Use of Safety Devices (Arterial Line Air Bubble Detector, VARD, Level
Detection, AutoClamp) and Safety Systems (Bio-Pump Backflow Alert) is
recommended to aid in the detection and elimination of gaseous bubbles in the
extracorporeal circuit.
■
When handcrank operation of a roller pump is necessary due to a failure of the
motor or motor controller, the roller pump digital display may remain illuminated.
Any RPM/flow values that are being displayed will not correlate to the manual
RPMs or flow generated using the handcrank.
■
A fluid isolator is necessary in the pressure monitoring line to prevent contact of
sterile fluid path with the instrument and damage to the instrument and pressure
system.
■
Do not bypass the fluid isolator/filter in the pressure lines for the pressure
connectors (PR1 through PR8, ALP, and VLP) or fluid could enter the transducer
and damage internal components.
■
Do not introduce fluid into the male pressure luer connections on the console.
■
Do not connect the external temperature probes in conjunction with
electrocautery usage; this may compromise the temperature values measuring.
■
The device has been designed and tested in conformity with the Electro-Magnetic
Compatibility standard EN60601-1-2 (2003). It is advisable, however, to avoid its
use in the presence of electromagnetic fields or other equipment causing
interference (eg, cellular phones). Special information regarding installation, use,
and precautions are described in “Electromagnetic Emissions and Immunity
Declarations” on page 3-6.
■
The utilization of other manufacturers' probes (eg, flow and temperature) may
jeopardize the performance of the device and, as a consequence, the
measurement reliability.
■
The equipment is not protected against defibrillator discharges.
AAR Controller
AutoClamp System
1-6 Operator’s Manual
■
Do not operate the Active Air Removal (AAR) system with device or components
other than the Medtronic
®
Resting Heart™ Module. There are no safety or
performance data known to Medtronic that establish compatibility of any other
manufacturer's device or components with the AAR system. Any substitution of
components becomes the responsibility of the user. Such substitution will void
Medtronic's warranty and the user will bear full responsibility for any adverse
consequences stemming from such use.
■
Do not use the integrated AAR Controller until proper operating conditions are
verified. Prior to each use, it is the responsibility of the user to determine that the
system is in proper operating condition as described in this manual.
■
To prevent backflow of the patient's blood when the pump outlet tubing is open,
establish and maintain a minimum pump speed that overcomes line and patient
resistance. Use the AutoClamp System on the arterial line. Failure to do this could
allow retrograde flow and introduce air into the arterial circuit.
Introduction
Warnings
■
Prior to configuring the Arterial AutoClamp to CLOSE when the Bio-Pump enters
the COAST mode, it is the user's responsibility to test their extracorporeal circuit
and confirm the conduct of perfusion at their institution does not generate arterial
backflow when the Bio-Pump enters the COAST mode or the Bio-Pump speed is
manually reduced to the “detent” position.
■
If the Bio-Pump enters the Coast Mode in response to the “AIR DETECTED BY
ABD” alarm, pump RPM will remain at 2000 and will not automatically ramp up
after the air is no longer detected by the ABD or after the ABD is turned off. Flow
can only be resumed manually after careful assurance that air has been
completely removed from the arterial circuit.
■
If the Bio-Pump enters the Coast Mode in response to the “AIR DETECTED BY
ABD” alarm and the AutoClamp is configured to CLOSE, the AutoClamp will not
automatically OPEN after Bio-Pump flow is resumed. The user must manually
press the AutoClamp button on the Main Run Screen to open the clamp after
careful assurance there will be forward flow.
■
The Self Test must be performed prior to each use of the device. If the AutoClamp
System does not operate as described during the Self Test, do not use the
AutoClamp System. Contact Medtronic Service.
■
Resume flow only after careful assurance there is no air in the arterial circuit.
■
Ensure the air pressure to the AutoClamp System is within the range specified in
Chapter 3.
Battery/UPS
■
If a partially charged battery is used, there may be less than 30 minutes of battery
power available.
■
When the Uninterruptable Power Supply (UPS) converts the system to battery
power, ALL pumps, pump functions, safety systems, alerts, alarms, monitors,
controls, the Pinch Valve and the Central Information Display (CID) are active and
function the same as when the system is on AC power.
Main Power Switch
■
Ensure that the Main Power switch is off before storage, inspection, cleaning, and
preparation for use to disable both the battery power and wall AC power.
Central Information Display (CID)
■
If the CID fails during a procedure, the Performer CPB can be operated through
the local controls for the roller pumps and the Bio-Pump.
■
If the CID fails during a procedure, the sensors that have safety connections with
the Bio-Pump will remain enabled. The sensors that detect and measure blood
flow, Arterial Line Pressure (ALP), Venous Line Pressure (VLP), Venous
Saturation (SvO2), Hematocrit (Hct), Revolutions Per Minute (RPM), and
Cardioplegia Pressure can be displayed by scrolling through the Liquid Crystal
Display (LCD) display on the Bio-Pump control panel on the front of the console.
■
If the CID fails during a procedure, DO NOT turn the system power off as this will
cause all settings and device assignments to be lost.
■
The CID must be in the Home Screen for data to be downloaded into the
CompactFlash
allow a minimum of 10 seconds for the data download to complete before
removing the CompactFlash
®3
memory card. After the CID is changed to the Home Screen,
®
memory card.
3
CompactFlash® is a registered trademark of SanDisk Corporation.
Operator’s Manual 1-7
Chapter 1
Warnings
Tubing
Roller Pump
■
Using the Pre-Cardiopulmonary Bypass Parameters Screen with the
alpha-numeric keyboard during the conduct of cardiopulmonary bypass will cover
essential perfusion and cardioplegia delivery information screens. Enter data
prior to initiating bypass. Do not use during bypass.
■
Tubing must not be reversed in the roller pump as air embolism may occur.
■
Use only tubing of the material and sizes specified for this system.
■
Set the roller pump to the Stop Mode before installing tubing.
■
The roller pump safety cover interlocks are not enabled until after the Resting
Heart™ Screen is opened. Ensure that the roller pump safety covers remain
closed during the Power On Self-Test (POST).
■
The roller pump safety cover interlocks are not enabled until after the Resting
Heart™ Screen is opened. Ensure that the roller pump safety covers remain
closed when in the Emergency Mode.
■
The roller pump safety cover interlocks are not enabled until after the Resting
Heart™ Screen is opened. Ensure the roller pump safety covers remain closed if
roller pump function is required before enabling the Resting Heart™ Screen.
Handcrank
■
If handcrank operation is necessary due to the loss of AC and battery power, flow
detection and safety systems are inoperable. Closely monitor the circuit to prevent
introduction of air.
Bio-Pump
■
If air enters the Bio-Pump, stop perfusion as gaseous emboli may be introduced
into the patient.
■
If the Bio-Pump stops, immediately clamp the arterial line and venous line. Check
for air in the arterial line that may have resulted from backflow. If air is visible,
remove from the arterial circuit before resuming bypass.
■
If the Bio-Pump enters the Coast Mode in response to the “AIR DETECTED BY
ABD” alarm, pump flow will remain at 0.5 L/min and will NOT automatically ramp
up after the air is no longer detected by the ABD or after the ABD is turned off.
Flow can only be resumed manually after careful assurance that air has been
completely removed from the arterial circuit.
Power On Self-Test (POST)
■
Bypassing the POST when a system has failed may cause error messages or
malfunction during use.
■
If the POST repeatedly produces a FAILED indication, contact a Medtronic
service representative.
Air Bubble Detector (ABD)
■
A gray icon (with a red X) for the Arterial Line Air Bubble Detector icon indicates
the sensor is DISABLED and will not generate an alarm if air enters the arterial
circuit.
1-8 Operator’s Manual
Cautions
Introduction
Cautions
■
The Air Bubble Detector (ABD) sensor must be positioned at a sufficient distance
from the patient to allow the air detection system sufficient time to respond before
air can reach the patient.
■
The ABD sensor latch must be completely closed to secure the sensors to the
tubing.
■
The ABD sensor must be positioned so the cable is between the tubing and the
floor.
■
The performance of the ABD must be verified before each use.
■
A gray icon (with a red X) for the Cardioplegia (CPG) Air Bubble Detector icon
indicates the sensor is DISABLED and will not generate an alarm if air enters the
cardioplegia circuit.
■
Do not use sharp instruments on the CID, Bio-Pump control panel scroll arrows,
or the roller pump Start/Stop button as these may damage the device. Restrict
touching the screen with fingers only.
■
Installing the Bio-Pump with the motor revolving may damage the Bio-Pump.
■
When assembling the Bio-Pump Centrifugal Blood Pump, Model BPX-80, for use
with the Performer CPB, do not use alcohol or alcohol-based fluids. Do not expose
to chemical agents as they may affect the integrity of these devices. Anesthesia
solutions such as FORANE
4
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.
Operator’s Manual 1-9
Chapter 1
Cautions
1-10 Operator’s Manual
Safety Standards 2-2
Disposables and Accessories 2-2
Main Power Supply Failure 2-2
Electromagnetic Disturbance 2-3
Elimination of the Disposable Material 2-3
End of Life Disposition 2-3
Calibration 2-3
Technical Documentation 2-3
Safety
2
2
Replacing Fuses 2-3
Equipotential Connection 2-4
Battery Pack Disposal 2-4
Operator’s Manual 2-1
Chapter 2
Safety Standards
ATTENTION: The Performer CPB must be operated only by skilled personnel trained
for this task and in conformity to the present Operator’s Manual.
Safety Standards
The Performer CPB equipment complies with the essential requirements of the
Directive on Medical Devices 93/42 EEC (CE 0123)
The Performer CPB equipment also complies with the following international
standards:
Manufacturing safety, electrical safety:
■
■
■
■
Functional safety:
■
■
■
■
IEC 60513
IEC 60529
EN 60601-1
EN 60601-1-1 (2003)
ISO 14971
EN 60601-1-4
EN 60601-1-4/A1 (2000)
EN 60601-2-16
Electromagnetic compatibility:
■
EN 60601-1-2 (2003)
Disposables and Accessories
Use only disposables and accessories approved by Medtronic for use with the
Instrument. The use of other manufacturers' disposables and accessories has not
been validated by Medtronic and will void the warranty on the Instrument and may
jeopardize the functionality of the Instrument, possibly compromising patient safety.
Used accessories and parts may be used with the Instrument only when their
suitability for use has been established and certified, from the technical safety point
of view, by a person or entity authorized by Medtronic to test their performance with
the Instrument.
Main Power Supply Failure
In case of a main supply failure, fully-charged backup battery will allow treatment with
a fully loaded system to continue for a minimum of 30 minutes (see page 5-44).
2-2 Operator’s Manual
Electromagnetic Disturbance
The Performer CPB has been designed and tested to comply with the requirements
and tests of the electro-magnetic compatibility standard EN60601-1-2 (2003). It is
advisable, however, to avoid its use in the presence of strong electromagnetic fields
radiated from other equipment in the operating room (ie, defibrillators and
electrocautery devices) that may cause interference.
Special information regarding installation, use, and precautions are described in
“Electromagnetic Emissions and Immunity Declarations” on page 3-6.
The use of any accessory, probes, or cables other than those specified in this
document, including replacement parts, may result in either increased emissions or
decreased immunity of the Performer CPB.
Elimination of the Disposable Material
The disposables used in each treatment shall be disposed of using specific containers
and in conformity with local norms.
Safety
Electromagnetic Disturbance
End of Life Disposition
Do not dispose of this product in the unsorted municipal waste stream. Follow local
regulations for proper disposal. Please refer to Medtronic web site
http://recycling.medtronic.com for proper disposal guidance to ensure compliance
with the European Union’s Waste Electrical and Electronic Equipment (WEEE)
Directive.
Calibration
The calibration shall be performed only by authorized personnel.
Technical Documentation
The Service Manual, with electrical schemes, calibration procedures, and component
lists, will be provided upon request, for exclusive use by authorized, trained personnel.
Replacing Fuses
No auto-restoring fuses are present on the Performer CPB equipment; only internal
and external non-restoring fuses.
The replacement of a malfunctioning internal fuse(s) must be performed by
authorized, trained personnel.
The replacement of a malfunctioning external fuse(s) must be performed by using the
correct fuse(s) type as indicated by the external label and by the manufacturer (see
“General Data” on page 3-2).
Operator’s Manual 2-3
Chapter 2
Equipotential Connection
Equipotential Connection
Specific connection for the potential equalization is available on the Performer CPB in
case the local regulations require “potential compensation” by means of connection
to the potential compensation network.
The potential equalization connection is also recommended if other pieces of
equipment are used in combination with the Performer CPB.
Battery Pack Disposal
The life of the rechargeable battery packs is foreseen up to 4 years (depending on the
number of charge/discharge cycles and on correct use). After this period, battery
replacement and disposal is provided by authorized, trained personnel.
2-4 Operator’s Manual
Technical Specifications
General Data 3-2
Technical Features 3-3
Electromagnetic Emissions and Immunity Declarations 3-6
Monitoring System for Hematocrit, Temperature and O2
Saturation 3-10
Temperature Probes 3-11
Battery Supply System (UPS) 3-11
IEC 60601-2-16 Compliance Chart 3-12
3
3
Operator’s Manual 3-1
Chapter 3
General Data
General Data
STATEMENT OF CONFORMITY AND CLASSIFICATION
The equipment is a Class IIB active medical device in conformity with Annex IX of the
European Council Directive MDD 93/42/EEC on Medical Devices.
The equipment is CE marked according to the Annex 2.3 of the European Council
Directive MDD 93/42/EEC on Medical Devices.
Electrical Data
Classification (as for EN60601-1) Class I, type BF
Operation Mode Continuous
Voltage 100 to 240 VAC ± 10%
Frequency 50 to 60 Hz ± 10%
Current max. 6 A (100 to 120V)
max. 3 A (220 to 240V)
Power absorption max. 600 VA
Earth leakage current < 300 µA
Patient leakage current < 100 µA
Potential equalization Connector available
External fuses (type 5 x 20) 2x F6.3A/250V (100 to 120V)
2x F3.15A/250V (220 to 240V)
Power Cord “Hospital Grade” type
Max. 3 m length
10A, 125V (North America)
10A, 250V (Europe)
Ingress Protection
(IP code as for IEC 60529)
Environmental Operating Conditions
Temperature +10°C to +40°C
Relative humidity 30% to 75% (noncondensing)
Atmospheric pressure 700 to 1060 mBar
Transport and Storage Conditions
Temperature -20°C to +60°C
IP 21: protected against solid foreign objects of
12 mm diameter and greater; protected against
drop water.
3-2 Operator’s Manual
Relative humidity 10% to 90% (noncondensing)
Atmospheric pressure 700 to 1060 mBar
Interface
External Motor Drive (Bio-Pump) 10-pin LEMO
VARD Sensor 10-pin LEMO
®1
(EGG.3B.310.CLL)
®
(EGG.1B.310.CLL)
Flow Probe / ABD 15-pin D-SUB
Level Sensors 7-pin LEMO
Auto Clamp 8-pin LEMO
Serial interface RS232 / RS485
(5 KV opto-isolated)
Dimensions and Weight
WxDxH 500 x 560 x 1000 - 1400 mm
Weight Approximately 90 kg
1
LEMO® is a registered trademark of LEMO USA, Inc.
Technical Features
9-pin D-SUB
Technical Specifications
®
(EGG.1B.307.CLL)
®
(EGG.2B.308.CLL)
Technical Features
Pump PM1
Unidirectional peristaltic pump with manual
operating system
■
Flows
Up to 3.7 L/min (9.5 mm (3/8 in) pump segment)
■
Up to 3.7 L/min (6.4 mm (1/4 in) and
6.4 mm (1/4 in) pump segments)
■
Up to 1.8 L/min (6.4 mm (1/4 in) pump segment)
Maximum tolerance ± 10%
Pressure range within tolerance -150 to +500 mm Hg
Protection system
■
Feedback with rotation signal detected on the
encoder.
■
Open-cover sensor (and subsequent pump
blockage).
Pump PM2 Unidirectional peristaltic pump with manual
operating system
■
Flows
Up to 1.5 L/min (9.5 mm (3/8 in) pump segment)
■
Up to 1.5 L/min (6.4 mm (1/4 in) and
6.4 mm (1/4 in) pump segments)
■
Up to 0.8 L/min (6.4 mm (1/4 in) pump segment)
Maximum tolerance ± 10%
Pressure range within tolerance -150 to +500 mm Hg
Protection system
■
Feedback with rotation signal detected on the
encoder.
■
Open-cover sensor (and subsequent pump
blockage).
Pump PM3 Unidirectional peristaltic pump with manual
operating system
■
Flows
Up to 0.6 L/min (6.4 mm (1/4 in) pump segment)
■
Up to 0.16 L/min (3.2 mm (1/8 in) pump
segment)
Maximum tolerance ± 10%
Pressure range within tolerance -150 to +500 mm Hg
Operator’s Manual 3-3
Chapter 3
Technical Features
Protection system
■
Feedback with rotation signal detected on the
encoder.
■
Open-cover sensor (and subsequent pump
blockage).
Pump PM4 Unidirectional peristaltic pump with manual
operating system
■
Flows
Up to 1.1 L/min (6.4 mm (1/4 in) and
6.4 mm (1/4 in) pump segments)
■
Up to 0.7 L/min (6.4 mm (1/4 in) and 3.2 mm (1/8
in) pump segments)
■
Up to 0.6 L/min (6.4 mm (1/4 in) pump segment)
Maximum tolerance ± 10%
Pressure range within tolerance -150 to +500 mm Hg
Protection system
■
Feedback with rotation signal detected on the
encoder.
■
Open-cover sensor (and subsequent pump
blockage).
Pressures (PR1, PR2, PR3, PR4,
Electronic measurement by means of sensors
PR7, PR8)
Operating range -500 to 500 mm Hg
Maximum tolerance ± 5 mm Hg from -200 to 500 mm Hg
± 10 mm Hg from -500 to -200 mm Hg
Protection system Test at time T1 (start-up self-tests)
Pressures (VLP, ALP) Electronic measurement by means of sensors
Operating range -500 to +750 mm Hg
Maximum tolerance ± 5 mm Hg from -200 to 500 mm Hg
± 10 mm Hg from -500 to -200 mm Hg and
from 500 to 750 mm Hg
Protection system Test at time T1 (start-up self-tests)
Note: The VLP and ALP pressure inputs have redundant protective pressure transducers.
Flow Meter Ultrasonic transit-time type
Tubing 9.5 mm (3/8 in) ID x 2.4 mm (3/32 in)
6.4 mm (1/4 in) ID x 1.2 mm (1/16 in) (Not yet
implemented.)
Accuracy ± 10% (1.0 to 7.0 L/min)
± 20% (-0.15 to 1.0 L/min)
Flow range 9.5 mm (3/8 in) ID x 2.4 mm (3/32 in) ➝ 1.0 to 7.0
L/min
6.4 mm (1/4 in) ID x 1.2 mm (1/16 in) (Not yet
implemented.)
Air Bubble Detector (ABD)
Sensitivity Single bubble 0.1 mL (5000 Micron) to 0.3 mL of air
at 7.0 L/min flow, 37°C, blood
3-4 Operator’s Manual
Technical Specifications
Technical Features
Cardioplegia Air Sensors Ultrasound detection system
Sensitivity 0.5 mL bubble volume at 500 mL/min
Safety system Automatic: self-test performed every 10 minutes
during the therapy
Fluid-In-Line Sensors (FIL) Ultrasound detection system
Sensitivity Able to detect presence of fluid in suction line
UPS System Uninterruptable Power Supply
Inlet voltage 24 V
Outlet voltage 24 V
Nominal current 6 A
Autonomy Minimum 30 min. (with fully loaded system - see
Buffer Battery Pack
Type 2x12V - 9 A/h
Recharging time 6 hours
Replacement 4 years max.
Buzzer Sound buzzer for alarms
Type Uninterrupted sound
Current 0.3 to 8.3 mA
Sound level > 60 dB a 1 m
Frequency 2500 Hz
External Communication Interface
Format Master-Slave Binary Communication
Cable RS-485/USB
Communication parameters:
Baud Rate
Bits Number
Parity
Stop Bit
Transmission Interval 1 second or greater
page page 5-44)
57800
8
Null
1
Printer Fixed-head thermal printer
Columns 52 … 104 (according to the character set)
Printing speed 3.5 cm/sec
Lines/sec 10
Character set extended ASCII
Paper width 111.5 mm
Power supply 24 V DC
Consumption 3.5 A max
Operator’s Manual 3-5
Chapter 3
Electromagnetic Emissions and Immunity Declarations
Memory Card
Ty p e C o m pa c t F l a s h
®
Card International Association (PCMCIA) adapter
with Personal Computer Memory
Heater
Weighing System
Syringe Pump
Reservoir Level Detection System (optional)
Type Capacitive
Reservoir Wall Thickness 1-3.5 mm (wall thickness for hard shell reservoir)
Number of Sensors 2
AutoClamp System (optional)
Ty p e P n e um a t i c
Clamp Force 14.5 Kg (32 lbs)
Tubing 9.5 mm (3/8 in) ID x 2.4 mm (3/32 in) PVC
Air Pressure Required 379 - 689 kPa (55 - 100psi)
Not yet implemented.
Not yet implemented.
Not yet implemented.
Electromagnetic Emissions and Immunity Declarations
Emissions Declaration
The Performer CPB equipment is intended for use in the electromagnetic environment
specified in the table below. The customer or the user of the Performer CPB
equipment should ensure that it is used in such an environment.
Emission test Compliance Electromagnetic environment-guidance
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonic
emissions
IEC 61000-3-2
Voltage fluctuation /
flicker emissions
IEC 61000-3-3
Immunity Declaration
The Performer CPB equipment is intended for use in the electromagnetic environment
specified in the following tables. The customer or the user of the Performer CPB
equipment should ensure that it is used in such an environment.
Tabl e 3-1 . Electromagnetic Emissions for all Equipment and Systems
Group 1 The Performer CPB equipment generates
Class A
Class A The Performer CPB equipment is suitable
Complies
(Reference EN60601-1-2)
radio frequency (RF) energy only as a
byproduct of its internal function. Therefore,
its RF emissions are very low and are not
likely to cause any interference in nearby
electronic equipment.
for use in all establishments other than
domestic and those directly connected to
the public low-voltage power supply
network that supplies buildings used for
domestic purposes.
3-6 Operator’s Manual
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