Terumo CDI 550 User manual

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DESCRIPTION
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CHG. NO.SYM.
1 1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
Ann Arbor, Michigan
Refer to ECO
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CDI SYSTEM 550 OPERATORS MANUAL, TEXT
895230
895230
B 91979 UPDATED CLEANING AND CHAPTER 9
C 91988 MADE CLARIFICATIONS TO CHAPTER 9
D 91992 UPDATED RS232 SYMBOL

i
Table of contents
What is the CDI System 550?..............................................................................1-1
Indications for use........................................................................................... 1-1
Contraindications............................................................................................ 1-1
Operator Profile .............................................................................................. 1-1
Training Requirements.................................................................................... 1-2
How to use this manual ....................................................................................... 1-2
Conventions.................................................................................................... 1-3
How the CDI System 550 works.......................................................................... 1-3
Before you begin.................................................................................................. 1-4
CDI System 550 components.............................................................................. 1-7
Monitor............................................................................................................ 1-7
Calibrator...................................................................................................... 1-11
Calibration gases.......................................................................................... 1-12
Terumo CDI Shunt Sensor............................................................................ 1-12
The Shunt Bypass Line................................................................................. 1-14
Terumo CDI Hematocrit/Saturation Cuvette..................................................1-15
Terumo CDI Monitor Pole Clamp.................................................................. 1-17
Terumo CDI Cable-head Bracket.................................................................. 1-18
Setup................................................................................................................... 2-1
Calibration............................................................................................................ 2-1
Installation ........................................................................................................... 2-3
Operation............................................................................................................. 2-4
Conclusion of case.............................................................................................. 2-5
Setting up the monitor ......................................................................................... 3-1
Turning on the monitor......................................................................................... 3-2
Choosing a monitor configuration........................................................................ 3-4
Preparing the printer............................................................................................ 3-6
Preparing the calibrator....................................................................................... 3-7
Preparing the Cable-head Bracket ...................................................................... 3-9
Chapter 1 Introduction
Chapter 2 Quick Start
Chapter 3 Setting Up the Hardware

ii
Setting up and starting calibration....................................................................... 5-1
Concluding calibration ......................................................................................... 5-8
Verifying calibration.............................................................................................. 5-9
Preparing to install sensors ................................................................................. 6-1
Installing the Shunt Bypass Line and CDI H/S Cuvette....................................... 6-1
Installing a CDI Shunt Sensor ............................................................................. 6-2
Installing a CDI Shunt Sensor into the Shunt Bypass Line.................................. 6-4
Attaching the CDI H/S Probe for Hematocrit/Saturation measurement............... 6-6
Initiating “operate” mode...................................................................................... 7-1
Completing Calibration of the CDI System 550 measurements .......................... 7-3
Choosing display modes...................................................................................... 7-5
Setting the patient temperature mode................................................................. 7-8
Entering the blood flow rate ( )........................................................................... 7-8
Recalibrating during a procedure ........................................................................ 7-9
Batteries contained within the CDI System 550 ................................................ 7-11
System Batteries........................................................................................... 7-11
Operating on emergency battery power ....................................................... 7-11
Selecting options on the setup screens............................................................... 4-1
Setting printer options.......................................................................................... 4-2
System Notifications............................................................................................ 4-3
Physiological Alarms............................................................................................ 4-4
Manufacturer-Defined Default Alarm Limits......................................................... 4-4
Setting alarms...................................................................................................... 4-5
Choosing graphic displays................................................................................... 4-7
Choosing general settings................................................................................... 4-9
Specifying values used in calculations .............................................................. 4-10
Setting parameters for communicating with an external device......................... 4-12
Chapter 7 Monitoring a Patient
Chapter 5 Calibrating Sensors
Chapter 6 Installing Disposables
Chapter 4 Choosing System Settings
Table of contents

iii
Printing or sending a report................................................................................. 8-1
Returning the monitor to “standby” mode ............................................................ 8-2
Return the monitor to its pre-operation state....................................................... 8-2
Disposal of waste products.................................................................................. 8-3
Chapter 8 Concluding a Case
Routine cleaning................................................................................................ 10-1
Battery charging ................................................................................................ 10-2
Routine Maintenance Requiring Service........................................................... 10-3
System Battery Icon...................................................................................... 10-3
Monitor and Calibrator disposal......................................................................... 10-3
System Notification Specifications.......................................................................B-1
Manufacturer-Defined Default Alarm Limits.........................................................B-2
System operating ranges.....................................................................................B-2
System display ranges.........................................................................................B-3
Priming volumes..................................................................................................B-3
System accuracy limits........................................................................................B-4
Environmental and electrical specifications.........................................................B-5
Dimensions.....................................................................................................B-5
Error messages and conditions........................................................................... 9-1
Monitor Start Up ............................................................................................. 9-1
Printer............................................................................................................. 9-4
Calibration....................................................................................................... 9-5
Operate Mode............................................................................................... 9-10
Laboratory comparison troubleshooting table....................................................9-15
Technical support and replacement procedures................................................ 9-18
Fuse replacement......................................................................................... 9-18
Error Code Definitions .................................................................................. 9-19
Chapter 10 Routine Maintenance and Disposal
Chapter 9 Troubleshooting
Appendix B System Specications
Table of contents
Appendix A List of components

iv
Communication with other devices..................................................................... C-1
Connecting an external device to the data output port....................................... C-1
Data output port pin assignments....................................................................... C-3
Sending data to an external device .................................................................... C-4
ASCII Output.................................................................................................. C-4
Packet Mode Output ...................................................................................... C-7
Receiving blood flow data from pumps............................................................. C-14
Pump interfacing tips ................................................................................... C-15
CDI Pump Interface Protocol....................................................................... C-17
Electrical.........................................................................................................B-6
Environment....................................................................................................B-9
EMC Tables...................................................................................................B-10
Safe Working Loads...........................................................................................B-15
Additional Warnings and Precautions...........................................................B-15
Unpacking and inspection..................................................................................B-16
Calculations.......................................................................................................B-16
Appendix C Communication with other Devices
Appendix F Patent Information
Appendix D Symbols Glossary
Appendix G Software License
Appendix E Warranty and Service
Appendix H Glossary
Warranties .......................................................................................................... E-1
Limitations of Remedies..................................................................................... E-1
Service................................................................................................................ E-2
Returned Goods Policy....................................................................................... E-2
Appendix B System Specications
Table of contents

introductionchapter 1 1-1
What is the CDI®System 550?
The Terumo Cardiovascular Systems (Terumo CVS) CDI Blood Parameter Monitoring
System 550 (CDI System 550) is a blood monitoring system to be used on a single
patient during cardiopulmonary bypass procedures. It continuously monitors the
blood in the extracorporeal circuit and provides ongoing information about the blood
parameters. This information is displayed on the CDI System 550’s easy-to-read
screen.
The CDI System 550 monitors and displays the values of the following blood param-
eters:
Partial pressure of oxygen (PO2)
Partial pressure of carbon dioxide (PCO2)
pH
Potassium (K+)
Oxygen saturation (SO2)
Hematocrit (HCT)
Hemoglobin (Hgb)
Temperature
In addition, the CDI System 550 can calculate and display the following values:
Base excess (BE)
Bicarbonate ( )
Oxygen saturation (SO2) [calculated when measured is not available]
Oxygen consumption ( O2)
Oxygen delivery (ḊO2)
The CDI System 550 can display the blood parameters either at actual temperature or
adjusted to 37°C.
The CDI System 550 and all related accessories are latex-free.
The CDI System 550 includes a built-in printer that can provide a printed copy of the
displayed blood parameter values.
Indications for Use
The CDI System 550 provides continuous, on-line monitoring of the extracorporeal
partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, he-
matocrit, hemoglobin and temperature. In addition, calculated values of base excess,
bicarbonate, oxygen saturation, oxygen delivery, and oxygen consumption may also
be provided. These parameters are displayed at either actual temperature or adjusted
to 37°C. For documentation purposes, the systems integral printer provides a hard
copy of displayed parameters.
Contraindications None
HCO3

introductionchapter 11-2
Operator Prole
This device is typically operated by a perfusionist and is not left unattended. A perfu-
sionist usually possesses a degree with various levels of experience and perfusion-
specic education. Some perfusionists may have other healthcare credentials. In some
countries, the perfusionist completes a formal educational perfusion program followed
by clinical practice prior to becoming certied and/or licensed to practice. In other coun-
tries, the perfusionist does not complete a formal perfusion education program, and
learns the profession by practice and on-the-job training only.
Minimum Physical Requirements: Has physical ability to stand for long periods of time,
and to stoop, bend, reach, grasp, or feel as needed; capable of lifting approximately 25
lb. from the oor location to countertop height; Normal visual and audible acuity (with
correction if needed).
Training Requirements
Before you set up or operate the CDI System 550, it is vital that you read and under-
stand all the material in this manual. To arrange additional training, please contact your
local Terumo Cardiovascular Systems representative or call 1-800-521-2818 and ask
about CDI System 550 training.
How to use this manual
Before you set up or operate the CDI System 550, it’s vital that you read and under-
stand all the material in this manual.
Once you’re familiar with the contents of the manual, you can use it as needed for refer-
ence. To help you nd things quickly, here’s a description of the manual’s organization.
Getting Started
Chapter 1 introduces the CDI System 550 and its parts.
Chapter 2, “Quick Start,” gives an overview of the tasks required to set up and use
the system.
Using the CDI System 550
Chapter 3 explains how to set up the monitor, calibrator, and printer.
Chapter 4 shows how to specify the appropriate software settings.
Chapter 5 tells how to calibrate the sensors.
Chapter 6 gives instructions for installing the sensors in the extracorporeal circuit.
Chapters 7 and 8 describe how to use the system during a procedure.
Reference
Chapter 9 gives information to help you troubleshoot problems.
Chapter 10 contains instructions for system maintenance.
Appendices A and B list the system components and specications (respectively).
Appendix C gives instructions for communicating with an external device.
Appendices D, E, F and G contain information about the product symbols, warranty,
service policy, patents, and software license (respectively). Appendix H is a glos-
sary of terms.

introductionchapter 1 1-3
If, upon reading this manual, you nd that you need clarication or additional informa-
tion, you can direct questions to your local Terumo Cardiovascular Systems represen-
tative, or to:
Terumo Cardiovascular Systems
6200 Jackson Road, Ann Arbor, MI 48103 USA
Phone: [phone]
Conventions
This manual contains important warnings, cautions, and notes:
Warning
• Warnings like this alert you to safety issues with the CDI System 550.
You must read these warnings before using the CDI System 550.
Caution
• Cautions contain important information about the operation and
maintenance of the CDI System 550. Read these carefully in order to avoid
any problems.
Note: Notes contain information that help with the operation of the CDI System 550.
How the CDI System 550 works
The CDI System 550 is an AC-powered, microprocessor-based monitor. It uses an
optical uorescence technology to measure blood gases, pH, and potassium. In addi-
tion, it uses an optical reectance technology to measure oxygen saturation, hemato-
crit, and hemoglobin.
Optical uorescent measurement. Two cable assemblies, one Arterial and one
Venous (Optional) connect the monitor to disposable CDI Shunt Sensors which are
inserted into the extracorporeal circuit. The CDI Shunt Sensors contain uorescent
microsensors, which are the heart of the CDI System 550 measurement system.
Light emitting diodes (LEDs) in the cable-heads direct light pulses towards the micro-
sensors.
The microsensors are composed of uorescent chemicals that emit light in response
to the stimulating pulses. The intensity of the emitted light depends upon the concen-
trations of potassium, oxygen, carbon dioxide and hydrogen ions coming into contact
with the microsensors. The light emitted by the uorescent microsensors is returned
to the cable-heads and measured by a light detector. The output signal of the detec-
tor is converted by the microprocessor to numerical data, which is displayed on the
monitor’s screen.

introductionchapter 11-4
Optical reectance measurement. The monitor’s optical probe sensing surface
contains light emitting diodes (LEDs) and a photodetector. The LEDs direct light
pulses at the blood through an optical window in the Terumo CDI H/S Cuvette, which
is inserted into the extracorporeal circuit. The intensity of the resulting reections are
analyzed (on the basis of the characteristic spectra of the oxy- and deoxy- forms of
hemoglobin) to determine the oxygen saturation, hematocrit, and hemoglobin. These
values are displayed on the monitor’s screen.
Before you begin
You must read and understand all the information in this manual — the CDI Blood
Parameter Monitoring System 550 Operator’s Manual — and the instructions for use
that came with associated disposables before using the system. Pay special attention
to the following important safety information:
• The shunt sensor accessory contains Germall II in the calibration uid.
A potential byproduct of Germall II may be Formaldehyde. Exposure
may cause adverse reactions in patients with Formaldehyde sensitivity.
• The shunt sensor is heparin treated and should not be used with
heparin sensitive patients. Devices with heparin treated surfaces may
cause an adverse reaction.
• Use of the following substances can potentially cause inaccuracies in
displayed values: Indocyanine green (Cardiogreen), Methylene Blue,
or other intravascular dyes, carboxyhemoglobin or situations such as
dyshemoglobins, hemoglobinopathies, elevated bilirubinemia and/or
icterus (jaundice).
• Verify the accuracy of displayed values with another source (i.e.
laboratory or point of care blood gas analyzer) before initiating
treatment.
Warning
• Possible explosion hazard. Do not use the CDI System 550 Monitor in
the presence of ammable anesthetics or other explosive gases.
• Do not use an apparently malfunctioning device in an operation.
• Computer equipment in the operating room environment may interfere
with the operation of existing monitoring or therapeutic devices, and
may be susceptible to interference from such devices. To ensure that
such interference will not occur, care must be taken in the selection of
computer equipment or printers to be interfaced with the CDI System
550 Monitor and in the manner in which this interface is accomplished.
• Maintain adequate levels of anticoagulation during extracorporeal
circulation by monitoring activated clotting time (ACT) or another
appropriate measurement. Use of a heparin treated device does not
substitute for adequate anticoagulation levels.

introductionchapter 1 1-5
• Do not modify this equipment without written authorization from the
manufacturer.
• Equipment connected to the monitor’s serial port shall meet IEC 60601-
1 current leakage specications. The combination of the two pieces of
equipment shall be checked for safe system/leakage current.
• Do not immerse the CDI Blood Parameter Module (BPM) or CDI H/S
Probe in liquid at any time. Immersion can cause damage to electronic
components within the beroptic head.
• Avoid prolonged exposure to high humidity environments.
• When Methylene Blue or similar dyes have been used prior to or
during cardiopulmonary bypass, independent external blood gas
and blood chemistry analysis is required for accurate determination
of all measured parameters needed to guide therapeutic decisions.
Readings obtained from the CDI System 550 for the following
parameters should not be relied on to make therapeutic decisions
when Methylene Blue has been used: pH, K+, Base Excess,
Bicarbonate, Oxygen Delivery, Oxygen Saturation, and Oxygen
Consumption.
• Blood conditions such as hemoglobinopathies, thalassemia, and
variety of anemic conditions (sickle cell, iron deciency, macrocytic),
may affect the accuracy of hemoglobin and hematocrit measurements.
Independent external analysis is required for accurate determination of
these measurements as needed to guide therapeutic decisions.
• The CDI System 550 should only be used when there is blood ow
through the extracorporeal circuit. To perform accurately, the H/S
Cuvette requires blood ow rates shown in the following table:
H/S Cuvette Size Min Flow Max Flow
1/2" 1.0 LPM 7.0 LPM
3/8" 0.5 LPM 4.0 LPM
1/4" 0.2 LPM 1.5 LPM
The Terumo CDI Shunt Sensor requires a minimum of 35 ml/min.
Restoration of blood ow above the minimum through the CDI Shunt
Sensor or the Terumo CDI H/S Cuvette will restore performance of the
system.
• Do not make simultaneous contact with the patient and certain parts of
non-medical electrical equipment. Certain parts that can be accessed
without the use of a tool (e.g. connectors or communication ports) may
contain live voltages.
• Independent external blood gas and blood chemistry analysis is
required for accurate determination of all measured parameters needed
to guide therapeutic decisions whenever intravascular dyes are
administered or when dyshemoglobins or elevated bilirubin levels are
present.
• Use caution when administering novel pharmacological agents when
the user is unfamiliar with the potential effect of such agents on the
CDI sensors.

introductionchapter 11-6
• Do not attempt in vivo recalibration expecting to re-align values affected by
interference due to intravascular dyes or pharmacological agents; the interference
may be prolonged resulting in continuing inaccuracies.
• Exposure of the shunt sensor to prime solutions and/or blood with pH less than
7.0 or greater than 7.8 pH units can interfere in the accurate measurement of
potassium.
• Exposure of the shunt sensor to prime solutions and/or blood with sodium
measurement less than 120 or greater than 160 mEq/L can interfere in the accurate
measurement of potassium.
• Do not expose the monitor to condensing (water vapor) conditions. Condensation
may occur when the instrument is equilibrated to a warm and humid environment
and then is rapidly subjected to a much colder room temperature. Condensation
may affect the measurement performance of the monitor.
• Do not expose the monitor to large changes in environmental temperature (>10°C)
or humidity (>20%) during use. Such changes may affect the measurement
performance of the monitor. If exposed to severe environmental changes (>10°C),
allow the monitor to equilibrate to the new environment for 24 hours before using.
• Failure to perform a proper set-up including a full two point tonometered gas
calibration, and a complete calibration of the potassium sensor and all other
parameters may inhibit the system from achieving accuracy limits found in
Appendix B.
• Measured values prior to initial in vivo calibration may not be accurate. Do not use
values prior to initial in vivo calibration for patient management. At the beginning
of a case after the initiation of cardiopulmonary bypass and when conditions are
stable, the user must complete calibration of all measurable blood parameters by
comparing them to a laboratory measurement done on a blood sample. The values
are dimmed on the CDI System 550 screen to indicate that the values are not
accurate until an initial in vivo calibration is performed.
• After changes of blood temperature of > 6°C, the user must repeat an in vivo
calibration of shunt sensor values once temperature stability has been achieved.
Optimal system accuracy will be maintained by this practice.
• The temperature measured by the shunt sensor is local to the sensor and does
not reflect the actual patient arterial or venous blood temperature. Do not use this
measurement for patient management.
• To avoid risk of electrical shock and to achieve grounding reliability, you must
connect this equipment to an equivalent receptacle (marked “Hospital Use” or
“Hospital Grade”) that has been inspected for proper grounding.
Caution
• Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order
of a physician.
• Do not connect a shunt sensor to an unprimed circuit. Prolonged “dry” exposure can
damage the sensors.
• Do not use chemical solvents such as alcohol, ether, and acetone — or anesthetics
such as Forane (isouorane) — as cleaning agents on any part of the system. These
chemicals can be destructive to the device. Follow the cleaning procedure in Chapter
10, “Routine Maintenance,” using only the recommended cleaning agents.

introductionchapter 1 1-7
Note: The hemoglobin measurement technique used in this instrument measures
total hemoglobin, and therefore includes other hemoglobin species such as carboxy-,
met-, sulf-, and fetal hemoglobin. Terumo CDI blood parameter monitoring systems
are intended to monitor blood gas values including pH, PCO², PO², K+, Oxygen Satu-
ration (SO²), Hematocrit (HCT), and Hemoglobin (Hgb). When used in accordance
with their instructions for use, the systems have been demonstrated to provide reliable
reports of these values with an accuracy characterized in Appendix B of the Opera-
tor’s Manual.
Caution
• Failure to follow the instructions can cause the monitoring system to display
inaccurate values.
The accuracy of the results is dependent upon the following:
• Reading and understanding the instructions for use
• Proper set-up, full two point tonometered gas calibration, and complete
calibration of the potassium sensor and all other parameters
• Use of all available system features
• Periodic comparison to a laboratory reference sample
CDI System 550 components
Monitor
The next gure shows the front panel of the monitor (with ḊO2 enabled).
Note: The screens in this manual reect a particular conguration of modules
(“Arterial/Venous Blood Gases & Hematocrit/Saturation”). If you have a different set of
modules, your screens will look different from the ones in this manual.
331
D02
calibration
9-25-18
pH-stat
°
C
(11) (10) (1) (2) (4) (8)
(5) (12) (3) (7) (9) (13)(6)

introductionchapter 11-8
(1) Arterial parameter values (highlighted in pink). pH values are displayed in pH
units, while PO2, and PCO2, can be displayed in either mmHg or kPa. Calcu-
lated base excess and bicarbonate are displayed in mEq/L.
(2) Venous parameter values (highlighted in blue). pH values are displayed in
pH units, while PO², and PCO², can be displayed in either mmHg or kPa.
(3) Potassium value. Potassium (K+) values are displayed in mmol/L. If both
venous and arterial sensors are being used, the K+ is taken from the arterial
sensor.
(4) Hematocrit/Oxygen Saturation values. Oxygen saturation and hematocrit
are displayed as percentages (%), while hemoglobin is displayed in g/dl.
(5) Calculated values. Base excess (mEq/L), bicarbonate (mEq/L), arterial oxy-
gen saturation (%), oxygen delivery (ml/min or ml/min/m²), and oxygen con-
sumption (ml/min or ml/min/m²) are calculated values. If the CDI H/S Probe is
not used and the venous blood gas module is used, calculated venous oxygen
saturation is displayed.
Note: Calculated SO²values are distinguished by a “calc” label.
(6) Flow values. The pump ow rate, used for calculating oxygen consumption,
and Oxygen Delivery is entered either manually or through a pump connected
to the CDI System 550’s pump interface port.
(7) System map. Includes the labels for the different modes (setup, calibration,
standby, and operate) and the label for the operate mode display choice (nu-
meric, tabular, or graphic).
(8) Soft keys. Software-driven function keys. Their purpose can vary from screen
to screen.
(9) Navigation/input keys. Include the + (Plus), - (Minus), √ (OK), X (Cancel),
and (left-, right-, up- and down-arrow) keys.
(10) Message bar. The area that displays current system status and alarms (above
the parameter display window).
(11) Parameter display window. Contains mode-specic data or information dis-
plays.
(12) System mode select key. Pressing this key activates the system map.
(13) Operate mode toggle key. You press this key during operate mode to switch
among the three types of displays — numeric, tabular, and graphic.

introductionchapter 1 1-9
The next gure shows the side panel of the monitor.
(14) Arterial and/or venous blood parameter module (BPM) cable-heads.
Modules for monitoring pH, PCO2, PO2, potassium and temperature.
Caution
Do not stare directly into the light generated by the BPM LED.
(15) H/S (Hematocrit/Saturation) Probe. Module for measuring continuous oxy-
gen saturation, hematocrit, and hemoglobin.
(16) Cable-head ports. Secures the cable-heads to the monitor when the monitor
is not in use, protecting the cable-head optics.
(17) H/S probe holder. Secures the CDI H/S Probe to the monitor when the moni-
tor is not in use, protecting the CDI H/S Probe optics.
(18) Hematocrit/saturation optical reference color chip. Allows connection of
the CDI H/S Probe to the optical reference color chip. When the monitor is
powered on, the system automatically performs a self-check.
5000109
(16)
(16)
(15)
(18)
(17)
(14)

introductionchapter 11-10
This gure shows the back panel of the monitor.
(19) Data output port. Allows serial transmission of blood parameter values to an
external computer or data acquisition device. This port is a low voltage com-
munication port and is congured for data transmission. Application of voltages
greater than 5 Volts will damage the monitor.
(20) Pump interface port. Allows the input of blood ow data from a Terumo Sys-
tem 1/CDI Interface Module (Terumo), Sarns 8000 Communications Module
(Terumo), Sarns Centrifugal Pump (Terumo), BioConsole® 550/560 (Medtron-
ic), S5/C5 (LivaNova/Sorin/Stöckert), HL 20/Rotaow Console (Maquet/Jostra),
NEO System (Terumo).
(21) Protective cap for pump interface port. Reduces the risk of ESD interference
when the pump interface port is not in use.
(22) Calibrator cable port. The receptacle for attaching the Terumo CDI Model 540
Calibrator.
(23) System power switch. Turns the power to the monitor on or off. When the
monitor is turned off, the most recent calibration values and setup parameters
are saved in memory. After you turn the monitor back on, these values are
automatically recalled.
Note: To turn off the system completely, you must turn off the power switch. If the
power switch is left on and the cord unplugged, the battery will power the system (and
will be discharging).
Note: If you turn the monitor off, wait at least 5 seconds before powering monitor
back on.
(24) Battery charge indicator. When illuminated, indicates that the battery is being
charged by AC power. While the monitor is connected to AC power, this green
light shall be on steadily.
(29)
(19)
(20)
(22)
(23, 24)
(25, 26)
(27)
(28)
(31)
(30)
5000110
(32)
(21)

introductionchapter 1 1-11
(25) Power cord connector. The receptacle for the power cord (when connected to
an AC power supply).
(26) Power cord. The CDI System 550 hospital grade AC power cord.
(27) Fuse holder. Contains two fuses.
(28) Cable guide. Excess cable can be wrapped here for convenient storage when
not in use or during transport of the monitor.
(29) Handle. Allows the monitor to be carried or steadied during placement.
(30) Monitor bracket. Allows easy mounting (and dismounting) of the monitor to
the monitor pole clamp tray.
(31) Printer cover. Protects the printer and paper from spills.
(32) Ground equalization stud. This stud is used to reduce differences of electrical
potential between bodies of medical electrical devices and conductive parts of
other objects.
Calibrator
The CDI Model 540 Calibrator is designed for automatic calibration of the CDI Sys-
tem 550 Monitor and CDI Shunt Sensors, utilizing tonometered gases. The device is
designed so that two sensors can be calibrated at the same time.
Note: If only one CDI Shunt Sensor is to be calibrated, either calibrator pocket can be
used. Gas ow will be automatically shut off to the unused cable-head pocket.
(1) Calibrator cable. Connects the calibrator to the monitor. Once connected, the
calibrator receives its power from the monitor.
(2) Calibrator gas bottle receptacles. These hold the Gas A and Gas B bottles
properly, to ensure correct calibration.
(3) Calibrator pockets. Supports and aligns the sensor/cable-head assembly
during calibration.
AB
5400111
(2)
(3)
(1)
(4)
(5)

introductionchapter 11-12
(4) Calibrator mounting hook. Fits onto the monitor pole clamp for optional
mounting on the CDI Model CDI517 Pole Clamp.
(5) Calibrator cable guide. Allows wrapping of the calibrator cable when not in
use.
Calibration gases
The two-point tonometered calibration of the CDI Shunt Sensors requires the use of
precision mixtures of CO2and O2gas in order to expose the sensors to well-dened
pH, PCO2, and PO2values. The set of gas bottles shall provide enough gas for ap-
proximately 80 individual sensor calibration procedures.
Gas A (Terumo CDI Model CDI506): Gas B (Terumo CDI Model CDI507):
CO2: 7.5 +/- 0.1% CO2: 2.8 +/- 0.1%
O2: 27.5 +/- 0.1% O2: 4.0 +/- 0.1%
N2: Balance N2: Balance
Warning
• The contents of the gas bottles are under pressure. Protect them from
sunlight, and do not expose them to temperatures exceeding 50°C
(122°F). Do not pierce or burn them, even after use. Do not spray the
contents of the gas bottles on a naked ame or any incandescent
material.
Caution
• Check the expiration date on the gas bottles before use. Use of the
calibration gas bottles after expiration may result in inaccurate calibration.
Terumo CDI Shunt Sensor
The CDI Shunt Sensors contain the K+, PO2, PCO2, and pH uorescent microsen-
sors, as well as the thermistor contact site for
temperature measurement. The sensors are
single use, non-toxic, and non-pyrogenic.
The heparin-coated, sterile CDI Shunt Sen-
sors, Model CDI510H, are intended for place-
ment into shunt lines, purge lines, sampling
lines, shunt bypass lines, or any similar line
that has blood ow. A minimum ow require-
ment of 35 ml/min is necessary for proper
measurement.
The lter/sparger found on one end of the
sensor ensures a sterile barrier when the
sensor is placed into the calibrator.
The sparger on the lter is located inside the
sensor. Don’t remove this lter/sparger until
you are ready to place the sensor into the
circuit.
5100113
Filter/sparger
Shunt Sensor

introductionchapter 1 1-13
A transparent optical interface material found on the back side of the CDI Model
CDI510H Shunt Sensors provides a means of
5100113a
Optical
Interface
Thermal
well
Optical
Interface
consistent optical connection between the
sensor and the beroptic cable connector.
This material reduces the risk of measure-
ment errors caused by moisture trapped
between the microsensors and the cable-
heads. A thermal well on each sensor allows
the thermal transfer from the circuit to the
thermistor cap located on each cable-head.
Each sensor contains a buffered calibration
solution. This solution stabilizes the micro-
sensors during storage. It also reacts with
the tonometered gases during calibration to establish predictable pH, PCO2, and PO2
values. This buffer solution works in conjunction with the calibration gases during
post-calibration checks (which are described in the section “Verifying calibration” in
Chapter 5).
Each CDI Shunt Sensor is intended for a single use. Aseptic technique must be used
when adding the CDI Shunt Sensor to the circuit. Luer caps and a sterile lter/sparg-
er assembly are provided on the sterile assemblies at each end of the shunt sensor to
protect the blood pathway from contamination prior to insertion into the circuit.
The CDI Shunt Sensor remains sterile as long as the package is unopened and
undamaged. Each shunt sensor is individually packaged in a foil pouch and has a
recommended shelf life indicated by the lot number expiration date printed on each
package. For additional information, refer to shunt sensor instructions for use.
Warning
• Products treated with the heparin treatment should not be used on
patients with heparin sensitivity.
• Maintain adequate levels of anticoagulation during extracorporeal
circulation by monitoring activated clotting time (ACT) or another
appropriate measurement. Use of a heparin treated device does not
substitute for adequate anticoagulation levels.
• Store CDI Shunt Sensors between 0°C (32°F) and 35°C (94°F). Freezing
of the CDI Shunt Sensor, or storage at temperatures outside the stated
range, can result in inaccurate performance.
• Do not reuse CDI Shunt Sensors. Used CDI Shunt Sensors are
contaminated and cannot be resterilized. Resterilization damages the
microsensors.
• Shunt Sensors are sterile, heparin-coated, non-toxic, non-pyrogenic,
single use devices and for use in cardiopulmonary bypass procedures
for up to 6 hours.
• Use of certain intravascular dyes during cardiovascular surgery such
as: Indocyanine green (Cardiogreen) and Methylene Blue may cause
inaccuracies in displayed values. Independent external blood gas and
blood chemistry analysis is required for accurate determination of all
measured parameters needed to guide therapeutic decisions.

introductionchapter 11-14
• Elevated levels of blood substances including irregular cell
morphologies, protein levels, plasma free hemoglobin and bilirubin
may interfere with blood measurements. Independent external
blood gas and blood chemistry analysis is required for accurate
determination of all measured parameters needed to guide therapeutic
decisions.
• Independent external blood gas and blood chemistry analysis is
required for accurate determination of all measured parameters needed
to guide therapeutic decisions whenever intravascular dyes are
administered or when dyshemoglobins or elevated bilirubin levels are
present.
• Use caution when administering novel pharmacological agents when
the user is unfamiliar with the potential effect of such agents on the
CDI sensors.
• Do not attempt in vivo recalibration expecting to re-align values
affected by interference due to intravascular dyes or pharmacological
agents; the interference may be prolonged resulting in continuing
inaccuracies.
Caution
• Do not use a CDI Shunt Sensor after the lot number expiration date printed
on the package label. Using a CDI Shunt Sensor after its lot number
expiration date can result in inaccurate performance.
• Do not use a CDI Shunt Sensor if the foil pouch it is packaged in has been
damaged. A damaged foil pouch can result in inaccurate performance.
• This product contains Germall II in the calibration uid. A potential byproduct
of Germall II may be formaldehyde. Exposure may cause adverse reactions
in patients with formaldehyde sensitivity.
The Shunt Bypass Line
The shunt bypass line is a tubing pack modication designed to allow connection of
the CDI Shunt Sensor when an “in-line” application is desired. Two opposing Y-con-
nectors allow a small fraction of the total blood ow to pass through the sensor while
minimizing any additional ow resistance. The shunt bypass line is recommended
when continuous venous side monitoring is desired and/or when a continuous shunt/
purge line is not available on the arterial side. The lines can be supplied as sterile
individual assemblies for incorporation into the
circuit at the time of use, or by a tubing pack
supplier as a modication to an existing tube
pack. Three tubing sizes are supported: 1/2",
3/8" and 1/4".

introductionchapter 1 1-15
Warning
• The CDI System 550 is not intended for use in situations in which
there is no ow of blood through the CDI Shunt Sensor. A minimum
blood ow of 35 ml/min is recommended to maintain measurement
performance of the shunt sensor. Flows below the minimum may
result in a slower time response. To maintain the minimum blood
ow through the sensor, keep total blood ow in the shunt bypass
line above 1.5 L/min for 1/2 inch tubing, 0.6 L/min for 3/8 inch tubing,
and 0.2 L/min for 1/4 inch tubing. Restoration of minimum blood
ow through the shunt line after an interruption will restore optimal
performance of the system.
• Use aseptic technique when inserting the shunt bypass line into the
extracorporeal circuit to ensure that the blood contact surfaces remain
sterile.
• For all shunt bypass line applications: Use an arterial lter distal to the
shunt bypass line when utilizing the shunt bypass line on the arterial
side of the circuit.This protects against the introduction of air into the
blood circulation.
Caution
• For single sterile shunt bypass line assemblies. Do not use the shunt
bypass line after the date printed on the package label. Use beyond the
date may result in inaccurate performance.
• The shunt bypass lines, which are supplied sterile, will remain so as long as
the package is unopened and undamaged.
• Secure all connections on the shunt bypass line with stay straps.
Terumo CDI Hematocrit/Saturation Cuvette
The CDI Hematocrit/Saturation (H/S) Cuvette is a ow-through device inserted directly
into the extracorporeal circuit. The CDI H/S Cuvette is for a single use only. It is sup-
plied sterile and individually packaged, for incorporation into the circuit at the time of
use, or can be supplied non-sterile to tubing pack manufacturers for pre-connection.
The CDI H/S Cuvette contains an optical window that provides a means of consistent
optical connection between the CDI H/S Probe and the CDI H/S Cuvette. A magnet
placed in the CDI H/S Cuvette provides verication of the correct connection between
the CDI H/S Probe and the CDI H/S Cuvette.