CDI 500 Operators Manual 2015

table of contents Chapter 1

Introduction

What is the CDI™ System 500? ... 1-1 Indications ... 1-1 Contraindications ... 1-1 Operator Pro¿le... 1-2 Training Requirements ... 1-2 How to use this manual ... 1-2 Conventions ... 1-3 How the CDI System 500 works ... 1-3 Before you begin ... 1-4 CDI System 500 components ... 1-7 Monitor ... 1-7 Calibrator ... 1-11 Calibration gases ... 1-12 TCVS CDI™ Shunt Sensor ... 1-12 The Shunt Bypass Line ... 1-14 TCVS CDI™ Hematocrit/Saturation Cuvette... 1-15 TCVS CDI™ Monitor Pole Clamp... 1-17 TCVS CDI™ Cable-head Bracket ... 1-17

Chapter 2

Quick Start: How to set up and use CDI System 500

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 con¿guration ... 3-4 Preparing the printer ... 3-6 Printer Style 1 ... 3-6 Printer Style 2 ... 3-7 Preparing the calibrator ... 3-8 Preparing the Cable-head Bracket ... 3-10

i

table of contents Chapter 4

Choosing System Settings

Selecting options on the setup screens ... 4-1 Setting printer options ... 4-2 Setting alerts ... 4-4 Choosing graphic displays... 4-5 Choosing general settings ... 4-8 Specifying values used in calculations ... 4-9 Setting parameters for communicating with an external device ... 4-11

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 500 Measurements ... 7-3 Choosing display modes ... 7-5 Setting the patient temperature mode ... 7-8 Entering the blood Àow rate ( ) ... 7-8 Recalibrating during a procedure ... 7-9 Operating on emergency battery power ... 7-11

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

ii

table of contents Chapter 9

Troubleshooting

Error messages and conditions ... 9-1 Monitor Start Up ... 9-1 Printer... 9-4 Calibration... 9-6 Operate Mode... 9-11 Laboratory comparison troubleshooting chart ... 9-15 Technical support and replacement procedures ... 9-18 Fuse replacement ... 9-18

Chapter 10

Routine Maintenance

Routine cleaning ... 10-1 Battery charging ... 10-2 Routine Maintenance Requiring Service ... 10-3 System Batteries... 10-3

Appendix A

List of System Components

Appendix B

System Speci¿cations

System operating ranges ...B-1 System display ranges ...B-1 Priming volumes...B-2 System accuracy limits ...B-2 Environmental and electrical speci¿cations ...B-3 Dimensions ...B-3 Electrical ...B-3 Environment...B-4 EMC Tables...B-5 Additional Warnings and Precautions . ...B-11 Unpacking and inspection ...B-11 Calculations ...B-11

iii

table of contents 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 Àow data from pumps ...C-14 Pump interfacing tips ...C-15 CDI Pump Interface Protocol...C-17

Appendix D

Symbols

Appendix E

Warranty and Service

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

iv

Appendix F

Patent Information

Appendix G

Software License

Appendix H

Glossary

What is the CDI™ System 500? The Terumo Cardiovascular Systems (TCVS) CDI™ Blood Parameter Monitoring (CDI System 500) 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 500’s easy-to-read screen. The CDI System 500 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 500 can calculate and display the following values: „ „ „ „

Base excess (BE) Bicarbonate (HCO3-) Oxygen saturation (SO2) [calculated when measured is not available] Oxygen consumption ( O2)

The CDI System 500 can display the blood parameters either at actual temperature or adjusted to 37°C. The CDI System 500 includes a built-in printer that can provide a printed copy of the displayed blood parameter values.

Indications The CDI System 500 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, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37°C. For documentation purposes, the system 500’s integral printer provides a hard copy of displayed parameters.

Contraindications None

.

introduction

1-1

Operator Profile This device is typically operated by a certi¿ed clinical perfusionist Rx Only quali¿ ed by professional credentialing and in some cases licensure that has undergone academic and clinical education to provide extracorporeal patient care services. Perfusion training programs are university based and are offered at the undergraduate level and at the postgraduate level to individuals who have obtained a bachelor’s degree in a related ¿eld. The perfusionist functions independently while under the direction of a physician.

Training Requirements Before you set up or operate the CDI System 500, 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 500 system training.

How to use this manual Before you set up or operate the CDI System 500, 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 ¿nd things quickly, here’s a description of the manual’s organization. „ Getting Started Chapter 1 introduces the CDI System 500 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 500 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 glossary of terms.

1-2

chapter 1

If, upon reading this manual, you ¿nd that you need clari¿cation 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 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 500. You must read these warnings before using the CDI System 500.

Caution • Cautions contain important information about the operation and maintenance of the CDI System 500. Read these carefully in order to avoid any problems. Note: Notes contain information that help with the operation of the CDI System 500.

How the CDI System 500 works The CDI System 500 is an AC-powered, microprocessor-based monitor. It uses an optical Àuorescence technology to measure blood gases, pH, and potassium. In addition, it uses an optical reÀectance technology to measure oxygen saturation, hematocrit, and hemoglobin. Optical Àuorescent measurement. Two cable assemblies (one venous and one arterial) connect the monitor to disposable CDI Shunt Sensors which are inserted into the extracorporeal circuit. The CDI Shunt Sensors contain Àuorescent microsensors, which are the heart of the CDI System 500 measurement system. Light emitting diodes (LEDs) in the cable-heads direct light pulses towards the microsensors. The microsensors are composed of Àuorescent 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 Àuorescent 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. Optical reÀectance 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 TCVS CDI™ H/S Cuvette, which is inserted into the extracorporeal circuit. The intensity of the resulting reÀections 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.

introduction

1-3

Before you begin You must read and understand all the information in this manual í the CDI™ Blood Parameter Monitoring System 500 Operator’s Manual í and the instructions for use that came with associated disposables before using the system. Pay special attention to the following important safety information: Warning • Possible explosion hazard. Do not use the CDI System 500 Monitor in the presence of Àammable anesthetics or other explosive gases.

1-4

chapter 1

•

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 insure that such interference will not occur, care must be taken in the selection of computer equipment or printers to be interfaced with the CDI 500 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 use products treated with the heparin treatment on patients with heparin sensitivity. Devices with heparin treated surfaces may cause an adverse reaction in patients with heparin sensitivity.

•

Equipment connected to the monitor’s serial port shall meet IEC 606011 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.

•

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.

•

If the lab-measured value is outside the operating range for a parameter, the user may not be able to adjust the CDI System 500 measured value to the lab-measured value. Accuracy has not been established for displayed values outside the operating range; therefore, displayed values outside the operating range should not be used for patient management. While this condition exists, continue patient management with another source (e.g., laboratory or point-of-care blood gas analyzer).

•

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.

•

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.

•

Blood conditions such as hemoglobinopathies, thalassemia and a 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 500 should only be used when there is blood Àow through the extracoporeal circuit. To perform accurately, the H/S Cuvette requires blood Àow 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 TCVS CDI™ Shunt Sensor requires a minimum of 35 cc/min. Restoration of blood Àow above the minimum through the CDI Shunt Sensor or the TCVS 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.

•

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.

•

A pH measurement greater that 9.0 or less than 6.8, or a sodium measurement greater than 160 or less than 120, can interfere in the accurate measurement of potassium by the CDI System 500.

•

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, 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 result in compromised system performance that does not meet the system accuracy limits found in appendix B.

introduction

1-5

•

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, 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 500 screen to indicate that the values are not accurate until an initial in-vivo calibration is performed.

•

The temperature measured by the shunt sensor is local to the sensor and does not reflect the actual patient arterial blood temperature. Do not use this measurement for patient management.

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.

•

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.

•

Do not use chemical solvents such as alcohol, ether, and acetone í or anesthetics such as Forane (isoÀuorane) í 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 Verify the accuracy of displayed values with another source (i.e. laboratory or point of care blood gas analyzer) before initiating treatment.

1-6

chapter 1

CDI System 500 components Monitor The next ¿gure shows the front panel of the monitor. Note: The screens in this manual reÀect 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. (11)

(10)

(1)

(2)

(8)

(4)

calibration

(5)

(12)

(3)

(7)

(9)

(6)

(13)

(1)

Arterial parameter values (highlighted in red). 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/1.

(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/1. 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.

introduction

1-7

(5)

Calculated values. Base Excess (meq/1), Bicarbonate (meq/1), arterial Oxygen Saturation (%), 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 Àow rate, used for calculating oxygen consumption, is entered either manually or through a pump connected to the CDI System 500’s pump interface port.

(7)

System map. Includes the labels for the different modes (setup, calibrate, 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 alerts (above the parameter display window). (11) Parameter display window. Contains mode-speci¿c 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.

1-8

chapter 1

The next ¿gure 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. (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.

introduction

1-9

This ¿gure shows the back panel of the monitor. (28)

(30) (19) (20) (21) (22, 23) (24, 25)

(31)

(26)

(27)

5000110

(29)

(19) Data output port. Allows serial transmission of blood parameter values to an external computer or data acquisition device. (20) Pump interface port. Allows the input of blood Àow data from a Terumo® Advanced Perfusion System 1, a TCVS Sarns™ Perfusion System 9000, a TCVS Sarns™ Modular Perfusion System 8000, a TCVS Sarns™ Centrifugal System, Stöckert1 SIII/SC, Jostra2 HL20, or a Medtronic Bio-Console®3 550, for use in the calculation of oxygen consumption. (21) Calibrator cable port. The receptacle for attaching the TCVS CDI™ Model 540 Calibrator. (22) 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. (23) Battery charge indicator. When lit, indicates that the battery is being charged by AC power. While the monitor is turned on and connected to AC power, this green light shall be on steadily. (24) Power cord connector. The receptacle for the power cord (when connected to an AC power supply). 1

Stöckert is a member of Sorin Biomedica.. Jostra is a registered trademark of Maquet GmbH and Company. 3 Bio-Console is a registered trademark of Medtronic, Inc. 2

1-10

chapter 1

(25) Power cord. The CDI System 500 is supplied with a hospital grade AC power cord. (26) Fuse holder. Contains two fuses. (27) Cable guide. Excess cable can be wrapped here for convenient storage when not in use or during transport of the monitor. (28) Handle. Allows the monitor to be carried or steadied during placement. (29) Monitor bracket. Allows easy mounting (and dismounting) of the monitor to the monitor pole clamp tray. (30) Printer cover. Protects the printer and paper from spills. (31) 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 500 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 Àow 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.

(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.

introduction

1-11

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-de¿ned pH, PCO2, and PO2 values. The set of gas bottles shall provide enough gas for approximately 80 individual sensor calibration procedures. Gas A (TCVS CDI™ Model CDI506): CO2: 7.5 +/- 0.1% O2: 27.5 +/- 0.1% N2: Balance

Gas B (TCVS 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 Àame 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.

TCVS CDI™ Shunt Sensor The CDI Shunt Sensors contain the K+, PO2, PCO2, and pH Àuorescent 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, vent lines, or any similar line that has blood Àow. A minimum Àow requirement 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.

1-12

chapter 1

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 Optical Interface sensor and the ¿beroptic cable connector. This material reduces the risk of measurement errors caused by moisture trapped between the microsensors and the cable-heads. A thermal well on Thermal well each sensor allows the thermal transfer from the circuit to the thermistor cap located on each cable-head. 5100113a

Optical Each sensor contains a buffered calibration soInterface lution. This solution stabilizes the microsensors 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/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

1-13

•

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.

•

Blood conditions such as hemoglobinopathies, thalassemia and a 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.

•

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 Àuid. 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-connectors allow a small fraction of the total blood Àow to pass through the sensor while minimizing any additional Àow resistance. The shunt bypass line is recommended when continuous venous side monitoring is desired and/or when a continuous shunt/ vent/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".

1-14

chapter 1

Warning •

The CDI System 500 is not intended for use in situations in which there is no Àow of blood through the CDI Shunt Sensor. A minimum blood Àow of 35 cc/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 Àow through the sensor, keep total blood Àow 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 Àow 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.

TCVS CDI™ Hematocrit/Saturation Cuvette The CDI Hematocrit/Saturation (H/S) Cuvette is a Àow-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 preconnection. 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. Note: When the CDI H/S Cuvette is inserted into the circuit, the optical window should be pointing down. This minimizes interference from intermittent air bubbles in the line. 5170116

Optical Window Magnets

introduction

1-15