CDI 550 Operators Manual Rev D

Table of contents Chapter 1

Introduction

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

Chapter 2

Quick Start

Setup... 2-1 Calibration... 2-1 Installation... 2-3 Operation... 2-4 Conclusion of case... 2-5

Chapter 3

Setting Up the Hardware

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

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Table of contents Chapter 4

Choosing System Settings

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 5

Calibrating Sensors

Setting up and starting calibration... 5-1 Concluding calibration... 5-8 Verifying calibration... 5-9

Chapter 6

Installing Disposables

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

Chapter 7

Monitoring a Patient

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

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Table of contents Chapter 8

Concluding a Case

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 9

Troubleshooting

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

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

Appendix A

List of components

Appendix B

System Specifications

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

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Table of contents Appendix B

System Specifications

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

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

Appendix D

Symbols Glossary

Appendix E

Warranty and Service

Warranties... E-1 Limitations of Remedies... E-1 Service... E-2 Returned Goods Policy... E-2

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Appendix F

Patent Information

Appendix G

Software License

Appendix H

Glossary

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 parameters: „„ 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 ( HCO3 ) 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, hematocrit, 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

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Operator Profile This device is typically operated by a perfusionist and is not left unattended. A perfusionist usually possesses a degree with various levels of experience and perfusionspecific 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 certified and/or licensed to practice. In other countries, 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 floor 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 understand 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 understand all the material in this manual. Once you’re familiar with the contents of the manual, you can use it as needed for reference. To help you find 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 specifications (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 glossary of terms.

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If, upon reading this manual, you find that you need clarification or additional information, you can direct questions to your local Terumo Cardiovascular Systems representative, or to:

Terumo Cardiovascular Systems 6200 Jackson Road, Ann Arbor, MI 48103 USA Phone: (800) 521-2818 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 fluorescence technology to measure blood gases, pH, and potassium. In addition, it uses an optical reflectance technology to measure oxygen saturation, hematocrit, and hemoglobin. Optical fluorescent 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 fluorescent 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 microsensors. The microsensors are composed of fluorescent chemicals that emit light in response to the stimulating pulses. The intensity of the emitted light depends upon the concentrations of potassium, oxygen, carbon dioxide and hydrogen ions coming into contact with the microsensors. The light emitted by the fluorescent microsensors is returned to the cable-heads and measured by a light detector. The output signal of the detector is converted by the microprocessor to numerical data, which is displayed on the monitor’s screen.

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Optical reflectance 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 reflections 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 fluid. 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

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•

Possible explosion hazard. Do not use the CDI System 550 Monitor in the presence of flammable 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.

•

Do not modify this equipment without written authorization from the manufacturer.

•

Equipment connected to the monitor’s serial port shall meet IEC 606011 current leakage specifications. 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 fiberoptic 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 deficiency, 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 flow through the extracorporeal circuit. To perform accurately, the H/S Cuvette requires blood flow rates shown in the following table: H/S Cuvette Size 1/2" 3/8" 1/4"

Min Flow 1.0 LPM 0.5 LPM 0.2 LPM

Max Flow 7.0 LPM 4.0 LPM 1.5 LPM

The Terumo CDI Shunt Sensor requires a minimum of 35 ml/min. Restoration of blood flow 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.

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•

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.

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•

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 (isofluorane) - 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.

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 Saturation (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 Operator’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 figure shows the front panel of the monitor (with ḊO2 enabled). Note: The screens in this manual reflect a particular configuration 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. (11)

(10)

(1)

(2)

(4)

(8)

9-25-18 °C

pH-stat

D02

331

calibration

(5)

(12)

(3)

(7)

(9)

(6)

(13)

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(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. Calculated 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 oxygen saturation (%), oxygen delivery (ml/min or ml/min/m²), and oxygen consumption (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 SO² values are distinguished by a “calc” label. (6)

Flow values. The pump flow 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 (numeric, 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-specific data or information displays. (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.

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The next figure shows the side panel of the monitor. (16)

(18) (17)

(16)

(14)

(15)

5000109

(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 oxygen 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 monitor 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.

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(29)

(21)

(31)

(19) (20) (22) (23, 24) (25, 26)

(32)

(27)

(28)

5000110

(30)

This figure 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 communication port and is configured for data transmission. Application of voltages greater than 5 Volts will damage the monitor. (20) Pump interface port. Allows the input of blood flow data from a Terumo System 1/CDI Interface Module (Terumo), Sarns 8000 Communications Module (Terumo), Sarns Centrifugal Pump (Terumo), BioConsole® 550/560 (Medtronic), S5/C5 (LivaNova/Sorin/Stöckert), HL 20/Rotaflow 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. 1-10

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(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.

A B

(2)

(4)

(3) 5400111

(1)

(5)

Calibrator The CDI Model 540 Calibrator is designed for automatic calibration of the CDI System 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 flow 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.

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(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 CO2 and O2 gas in order to expose the sensors to well-defined pH, PCO2, and PO2 values. The set of gas bottles shall provide enough gas for approximately 80 individual sensor calibration procedures.

Gas A (Terumo CDI Model CDI506): CO2: 7.5 +/- 0.1% O2: 27.5 +/- 0.1% N2: Balance

Gas B (Terumo CDI Model CDI507): CO2: 2.8 +/- 0.1% O2: 4.0 +/- 0.1% 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 flame 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 fluorescent microsensors, 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 Sensors, Model CDI510H, are intended for placement into shunt lines, purge lines, sampling lines, shunt bypass lines, or any similar line that has blood flow. A minimum flow requirement of 35 ml/min is necessary for proper measurement. The filter/sparger found on one end of the sensor ensures a sterile barrier when the sensor is placed into the calibrator. The sparger on the filter is located inside the sensor. Don’t remove this filter/sparger until you are ready to place the sensor into the circuit.

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Filter/sparger 5100113

Shunt Sensor

A transparent optical interface material found on the back side of the CDI Model CDI510H Shunt Sensors provides a means of consistent optical connection between the sensor and the fiberoptic cable connector. Optical Interface This material reduces the risk of measurement errors caused by moisture trapped between the microsensors and the cableheads. A thermal well on each sensor allows Thermal well the thermal transfer from the circuit to the thermistor cap located on each cable-head. Each sensor contains a buffered calibration 5100113a Optical solution. This solution stabilizes the microInterface 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 filter/sparger 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. introduction

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•

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 fluid. 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 modification designed to allow connection of the CDI Shunt Sensor when an “in-line” application is desired. Two opposing Y-connectors allow a small fraction of the total blood flow to pass through the sensor while minimizing any additional flow 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 modification to an existing tube pack. Three tubing sizes are supported: 1/2", 3/8" and 1/4".

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Warning •

The CDI System 550 is not intended for use in situations in which there is no flow of blood through the CDI Shunt Sensor. A minimum blood flow 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 flow through the sensor, keep total blood flow 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 flow through the shunt line after an interruption will restore optimal performance of the system.

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Use aseptic technique when inserting the shunt bypass line into the extracorporeal circuit to ensure that the blood contact surfaces remain sterile.

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For all shunt bypass line applications: Use an arterial filter 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.

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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.

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The shunt bypass lines, which are supplied sterile, will remain so as long as the package is unopened and undamaged.

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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 flow-through device inserted directly into the extracorporeal circuit. The CDI H/S Cuvette is for a single use only. It is supplied 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 verification of the correct connection between the CDI H/S Probe and the CDI H/S Cuvette.

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