HDI-PulseWave CR-2000 Operator's Manual Rev. G

Table of Contents

Table of Contents A Brief Message to the Users of the HDI/PulseWave™ CR-2000 Research CardioVascular Profiling System... i Symbols Used in this Manual and on the Product and Product Packaging ii

Introduction 1-1 CR-2000 Research System Description... 1-2 Indications... 1-2 Contraindications... 1-3 Intended Purpose of the CR-2000 Research System... 1-3 Basic Functions of the CR-2000 Research System... 1-4 Theory of Operation... 1-4 Component Descriptions... 1-11 Research CardioVascular Profiling Instrument... 1-12 Wrist Stabilizer... 1-12 Arterial PulseWave™ Sensor... 1-13 Sensor Holding and Positioning Device... 1-13 Three Adult Blood Pressure Cuffs... 1-13 Ink-Jet Printer... 1-14 Cords / Cables... 1-14 Safety Information... 1-16 Warnings... 1-16 Precautions... 1-17

Preliminary Procedures 2-1 Unpacking... 2-2 Shipping Carton Configuration... 2-3 Setting Up... 2-5 Connecting Cables / Hose / Cords to the CR-2000 Research Instrument... 2-6 Connecting the Power Cord and Data Cable to the Printer... 2-7 Remove Packing Material and Tape... 2-8 Loading Ink Cartridge... 2-8 Starting the CR-2000 Research Instrument and Printer... 2-10

Using the CR-2000 Research CardioVascular Profiling Instrument 3-1 Introductory Screens... 3-2 Display Screen “Hot Buttons”... 3-6 Error Beeping... 3-6 Updating Instrument Settings... 3-7 Check Pressure Calibration... 3-9

Blood Pressure Measurement 4-1 Research Subject Testing Environment... 4-2 Placing the Blood Pressure Cuff... 4-2 Measuring Blood Pressure... 4-4 Automatic Re-Inflation of Blood Pressure Cuff... 4-6

Creating and Storing Research Subject Records 5-1 Creating a Research Subject Record... 5-2

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Table of Contents Research Subject Information Screen...5-2 Storing a Research Subject’s Record...5-4

The CardioVascular Profile 6-1 Procedure for Performing a Research CardioVascular Profile...6-2 Wrist Stabilizer Placement...6-2 Placing the Arterial PulseWave™ Sensor...6-3 Measuring Blood Pressure and Recording Waveforms...6-5 Significance of Blood Pressure Waveform Data...6-6 How to Obtain an Acceptable Blood Pressure Waveform...6-6 Typical Blood Pressure Waveforms...6-9 Recording Data...6-13 Repeating a CardioVascular Profile on the Same Research Subject . . .6-13

Subject Records and Profile Reports 7-1 Reviewing Research CardioVascular Profile Reports...7-2 Information Provided on the Research CardioVascular Profile Report Screen...7-3 Printing a Research CardioVascular Profile Report...7-5 Example of Research CardioVascular Profile Reports...7-7 Transmitting Research CardioVascular Profile Report Data to a Personal Computer or Computer System...7-12 RS-232 Communication Specifications...7-13 Research Subject Profile Data Output Format...7-14 Cable Connection and Data Transmission Between CR-2000 Research System and an External Computer...7-15 Specific Instructions for Transmitting Profile Data from the CR-2000 Research CardioVascular Profiling Instrument to a Personal Computer...7-16

Appendices A-1 Appendix A: The Display Screens... A-2 Appendix B: Troubleshooting... A-21 Appendix C: Care and Maintenance... A-26 Appendix D: Fuse Replacement... A-29 Appendix E: Specifications of the CR-2000 Research CardioVascular Profiling System... A-32 Appendix F: Research Subject Height Conversion Table... A-35 Appendix G: Research Subject Data Limits... A-36 Appendix H: Limited Warranty... A-37 Appendix I: Registrations... A-39 Appendix J: Patents... A-40 Appendix K: Disclaimer - Product Changes... A-41 Appendix L: Copyright... A-42

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A Brief Message to the Users of the HDI/PulseWave™ CR-2000 Research CardioVascular Profiling System

A Brief Message to the Users of the HDI/PulseWave™ CR-2000 Research CardioVascular Profiling System Congratulations! You will be using one of the most advanced, user-friendly and non-invasive Research CardioVascular Profiling Systems available anywhere in the world. Our goal at Hypertension Diagnostics, Inc. is to provide you with an accurate and reproducible clinical research tool to investigate and evaluate human subjects in clinical research studies. We encourage you to contact us if you have any questions about the HDI/PulseWave™ CR-2000 Research CardioVascular Profiling System. Our telephone numbers are: Toll-Free in the U.S.A. 1-888-PULSEWAVE (1-888-7857392); Outside the U.S.A. Phone +1-651-687-9999; and TeleFax +1-651-6870485. We can also be contacted via Email at [email protected]. We look forward to hearing from you.

Note: HDI recommends that the user carefully read this Operator’s Manual in its entirety and that the user have a good understanding of how to use the CR-2000 Research System before actually starting to use it.

Caution: THE CR-2000 RESEARCH CARDIOVASCULAR PROFILING SYSTEM IS FOR “RESEARCH PURPOSES ONLY.” IT IS NOT INTENDED TO BE USED FOR THE SCREENING, DIAGNOSIS OR MONITORING OF PATIENTS.

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Symbols Used in this Manual and on the Product and Product Packaging

Symbols Used in this Manual and on the Product and Product Packaging CAUTION: Read instructions carefully CAUTION: Risk of electrical shock Keep Dry This side up Fragile Conformance to Council Directive (93/42/EEC) Medical Device On Off Fuse replacement location Ground Symbol EU Authorized Representative Use appropriate cuff size for limb circumference

Important Notes PLEASE CAREFULLY READ AND BE THOROUGHLY FAMILIAR WITH THE INSTRUCTIONS IN THIS MANUAL IN THEIR ENTIRETY, BEFORE ATTEMPTING TO USE THIS PRODUCT. YOUR ATTENTION IS DRAWN TO THE SAFETY INFORMATION AND PRECAUTIONS PRESENTED ON PAGES 1-17 TO 1-18 AND TO THE LIMITED WARRANTY DESCRIBED ON PAGES A-37 TO A-38.

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1. Introduction

1

CR-2000 Research System Description 1-2 Indications 1-2 Contraindications 1-3 Intended Purpose of the CR-2000 Research System 1-3 Basic Functions of the CR-2000 Research System 1-4 Theory of Operation 1-4 Component Descriptions 1-11 Research CardioVascular Profiling Instrument 1-12 Wrist Stabilizer 1-12 Arterial PulseWave™ Sensor 1-13 Sensor Holding and Positioning Device 1-13 Three Adult Blood Pressure Cuffs 1-13 Ink-Jet Printer 1-14 Cords / Cables 1-14 Safety Information 1-16 Warnings 1-16 Precautions 1-17

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Introduction CR-2000 Research System Description

CR-2000 Research System Description The HDI/PulseWave™ CR-2000 Research CardioVascular Profiling System is comprised of several components. The main component is the microprocessor computer. This computer is in an enclosure which includes a main electronics board, an electroluminescent touch-screen display, an oscillometric blood pressure module, an electrical power supply, and a resident set of proprietary, patented and licensed software programs. The enclosure has large rubber feet to protect connectors on the rear panel and a carrying handle which can be used as a stand to adjust the angle of the display screen. Also included with the CR-2000 Research System are an Arterial PulseWave™ Sensor, a Sensor Holding and Positioning Device, a Wrist Stabilizer, a Blood Pressure Cuff Hose, three Blood Pressure Cuffs (small, regular and large adult sizes), an Ink-Jet Printer and Black Ink Cartridge, and the required electrical power and data cables to set up and use the CR-2000 Research System. An electronic version of the Operator’s Manual and a manual for the Printer are also included with the equipment. A printed version of the Operator’s Manual is available upon request. More specific details about the equipment are provided in the Component Description Section.

Indications The HDI/PulseWave™ CR-2000 Research CardioVascular Profiling System is indicated for use in determining cardiovascular parameters in human subjects “For Research Purposes Only.” The CR-2000 Research System allows the Clinical Research Investigator to easily and quickly generate a Research CardioVascular Profile Report with several parameters of interest regarding human subjects engaged in clinical research trials. However, the use of the CR2000 Research System for the screening, diagnosis and monitoring of patients is strictly prohibited. The Report presents systolic, diastolic and mean arterial blood pressure values (determined by an oscillometric method), pulse pressure, pulse or heart rate, an estimate of stroke volume and cardiac output (using cardiac ejection time measured from the blood pressure waveform and an anthropometric-based calculation), the quanitation of both large and small artery elasticity indices (arterial compliance) based on a modified Windkessel model and employing a pulse contour analysis, and the determination by calculation of a value for systemic vascular resistance and total vascular impedance. In addition to presenting certain demographic data about the research subject, the Report also calculates and records the Body Surface Area (BSArea) in square meters and the Body Mass Index (BMI). Some, or all, of these hemodynamic parameters may be of value and interest as part of the clinical study protocol involving research trials with human subjects. The CR-2000 Research System is indicated for use with clinical research subjects of both genders at least ten (10) years of age or older. Subjects should be ambulatory and not have a diagnosis of heart failure, arrhythmia or cardiac valve abnormality (that is, aortic stenosis or mitral regurgitation). HDI/PulseWave™ CR-2000 Research CardioVascular Profiling System Revised DEC 2010

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Introduction CR-2000 Research System Description

Contraindications The use of the HDI/PulseWave™ CR-2000 Research CardioVascular Profiling System is contraindicated in the following circumstances: ■

Human subjects who weigh less than 50 lbs. (23 kg.) or more than 500 lbs. (227 kg.);

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The accuracy of the cardiovascular parameters cannot be assured with human subjects weighing more than about 330 lbs. (that is, about 150 kg.);

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With human subjects who are not ambulatory;

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With human subjects who have a diagnosis of heart failure, arrhythmia or cardiac valve abnormality (that is, aortic stenosis or mitral regurgitation);

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If movement at the monitoring location of the Arterial PulseWave™ Sensor on the subject’s wrist cannot be controlled;

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With subjects who have skin or vascular lesions at the sites where the Arterial PulseWave™ Sensor, the Sensor Holding and Positioning Device, the Wrist Stabilizer or restraint straps need to be positioned on the subject’s wrist; or

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With human research subjects who exhibit capillary fragility or excessive tendency to bruise.

Intended Purpose of the CR-2000 Research System The CR-2000 Research System is intended for use in clinical research applications only. It will enable a Clinical Research Investigator to easily and quickly obtain a variety of clinically important hemodynamic parameters from human subjects engaged in research trials and studies. It is not to be used for the screening, diagnosis or monitoring of patients under any circumstances.

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Introduction CR-2000 Research System Description

Basic Functions of the CR-2000 Research System The HDI/PulseWave™ CR-2000 Research CardioVascular Profiling System obtains upper-arm blood pressure values and waveform data by non-invasive methods, via the use of an oscillometric blood pressure module and via the application of specially designed equipment which includes an Arterial PulseWave™ Sensor within a Holding and Positioning Device. The embedded computer performs a “pulse contour analysis” of the calibrated, digitized blood pressure waveform data, and generates a Research CardioVascular Profile Report. The Clinical Researcher can view the Report parameters on the Instrument’s display and/or print a copy of the Report. The clinical research data collected and analyzed by the CR-2000 Research System are accurate and repeatable, and it can be used in determining important hemodynamic parameters relating to the structure, function and changes of a human subject’s cardiovascular system. The HDI/PulseWave™ CR-2000 Research CardioVascular Profiling System has been designed with a serial output port and the capability to allow the user to transmit Research CardioVascular Profile Report data to a personal computer or computer system external to the Instrument. When using the RS-232 Communications Port to transmit data, it is essential that the user connect it to an external computer which complies fully with a safety standard such as IEC 60950. Further, the user should verify that the entire CR-2000 Research System when connected to such an external computer still complies with safety concerns as presented in the IEC 60601-1-1 standard.

Theory of Operation The acquisition of calibrated radial artery blood pressure waveform data involves the coordinated use of a blood pressure cuff placed on the left upper-arm and a piezoelectric-based, direct contact, acoustical sensor placed over the right radial artery adjacent to the styloid process of the radius (by the wrist). The cuff systolic and diastolic pressures are utilized to calibrate the radial artery waveform data into units of pressure based on the median high and low value contained in a 30-second collection of blood pressure waveform data.

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Introduction CR-2000 Research System Description In addition to those hemodynamic parameters which are measured and/or calculated by the CR-2000 Research System, there are some data which are merely recorded and presented in the Profile Report. These include: the Research Subject Identification and Name, the date and time when the data were collected, and the age, gender, height and weight of the Research Subject. The Body Surface Area (BSArea) expressed in square meters is calculated via a formula shown later in this Section (see page 1-8), and the Body Mass Index (BMI) is calculated by dividing the Research Subject’s body weight (expressed in kilograms) by his/her height expressed in meters squared (that is, expressed as kg/m2). Another way of determining BMI is to take a Research Subject’s weight (expressed in pounds) divided by their height expressed in inches squared, and then multiply the resulting number by a units conversion factor of 703. In addition to showing the BSA and BMI values for the Research Subject on the Profile Report, the Relative Signal Strength in percent and the Serial Number of the CR-2000 Research Instrument are also printed.

Oscillometric Cuff Measurements Integral to the HDI/PulseWave™ CR-2000 Research CardioVascular Profiling System is an oscillometric blood pressure module that is utilized for cuff blood pressure measurements. The module performs blood pressure measurements based on a linear dynamic deflation method. The pressure in the cuff is initially inflated to approximately 180 mmHg if there is no preceding pressure reading (or to 50 mmHg above the previously determined systolic pressure). The pressure in the cuff is deflated at a set rate until it is well below diastolic pressure at which point the pressure in the cuff is released. A software algorithm internal to the module determines the systolic, mean and diastolic arterial pressure values as well as the pulse rate during the deflation phase. The first four values presented on the Research CardioVascular Profile Report, namely, systolic blood pressure, diastolic blood pressure, mean blood pressure and pulse rate are obtained by this oscillometric method. The pulse pressure is simply the difference in pressure expressed in millimeters of mercury between the systolic and diastolic values (that is, subtract diastolic pressure from systolic pressure to obtain pulse pressure).

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Introduction CR-2000 Research System Description

Waveform Acquisition and Analysis The Arterial PulseWave™ Sensor (the “Sensor”), used for obtaining high fidelity blood pressure waveforms, consists of a 0.5" diameter stainless steel canister with a 0.006" thick stainless steel diaphragm internally connected to a piezoelectric element and associated circuitry to amplify the waveform signal. The canister is attached to a manually adjustable shaft that is central to the Sensor Holding and Positioning Device (the “Holder”). The Holder is placed over the wrist and held in place with a hook-and-loop strap. The Holder allows the Sensor to be adjusted along the longitudinal axis of the radial artery as well as perpendicular to the artery in order to properly position the Sensor on the skin surface overlying the artery. In order to obtain acceptable blood pressure waveforms from the radial artery, the Sensor should be placed on the surface of the skin overlying the artery at the point of maximum pulsation. To optimize the quality of the signal, a degree of holddown pressure must be applied to the Sensor by gradually turning the Sensor knob in a clockwise direction. This brings the Sensor into close contact with the artery. The exact amount of hold-down pressure required is determined by observing and optimizing the relative signal strength shown on the display screen of the CR-2000 Research Instrument as well as by observing the qualitative shape of the blood pressure waveforms generated by the Sensor (see Section 6). The parameters presented in the Profile Report are derived from the analysis of the radial artery blood pressure waveforms obtained from the Sensor. These waveforms are calibrated to the oscillometrically-determined systolic and diastolic blood pressure cuff pressure values. The Research CardioVascular Profile Report summarizes the pulse contour analysis performed on a 30-second collection of the radial artery blood pressure waveforms. The results are based on the use of an electrical analog model (that is, a modified Windkessel model) which represents the vasculature as consisting of a capacitive compliance element (Large Artery Elasticity Index), an oscillatory or reflective compliance element (Small Artery Elasticity Index), an inductance and a resistance (Systemic Vascular Resistance), during the diastolic decay portion of the cardiac cycle.

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Introduction CR-2000 Research System Description The modified Windkessel model is represented as follows:

Definitions: P1 – Proximal Arterial Pressure P2 – Distal Arterial Pressure C1 – Large Artery Elasticity Index (Capacitive Arterial Compliance) C2 – Small Artery Elasticity Index (Oscillatory or Reflective Arterial Compliance) L – Inertance of the Blood R – Systemic Vascular Resistance Iin– Flow into the arterial system during systole Iin = 0 (or no flow) during diastole The non-forced or transient decay of the voltage in this model can be adjusted to match the varied diastolic decay shapes observed by appropriately selecting the values of model elements. The shape of this decay can then be represented as the solution to a third order differential equation of the Windkessel circuit model with six unknown ‘A’ parameters. The equation is as follows:

The actual analysis approach is to apply a non-linear curve fitting routine to match the shape of this third order equation to that of the diastolic decay. Mathematical relationships exist which relate the model values of C1 (Capacitive Arterial Compliance), C2 (Oscillatory or Reflective Arterial Compliance) and L (Inertance of the Blood) to the ‘A’ parameters and R (Systemic Vascular Resistance). The following equations show how the modified Windkessel model elements are related to the ‘A’ parameters and Systemic Vascular Resistance:

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Introduction CR-2000 Research System Description R is calculated independently as the Mean Arterial Pressure (expressed as mmHg) divided by the estimated Cardiac Output (expressed as Liters per minute) as follows:

A units conversion factor of 0.06 is multiplied by R in order to determine the arterial compliance values (expressed in units of ml/mmHg). The pulse contour analysis determines the mean pressure by integrating the area under each beat and then finding the average of all the beats included in the analysis. The mean pressure used above to determine Systemic Vascular Resistance, R, comes from the waveform analysis. To obtain the unit for R used in the Profile Report, a units conversion factor of 80 must be applied to MAP/CO. The Mean Arterial Blood Pressure value shown in the Profile Report is determined by the oscillometric method. The pulse contour analysis determines the pulse rate as the average pulse rate of the beats included in the analysis. The pulse rate, HR, that is used to determine estimated Cardiac Output comes from the waveform analysis. The pulse rate value that is shown on the Profile Report is determined by the oscillometric method. The estimated Stroke Volume and estimated Cardiac Output are based on an empirical formula derived from a multivariate analysis of subjects with normal left ventricular function as follows: SV = -6.6+0.25(ET - 35)-0.62HR + 40.4BSA - 0.51 Age (ml) CO = (SV . HR)/1000 (Liters/min) where ET = ejection time in milli-seconds BSA = body surface area (0.007184 . WT 0.425 . HT 0.725) WT = weight in kilograms HT = height in centimeters Age = age of the subject in years The estimated Cardiac Ejection Time value reported is determined from the radial artery waveform as the time period from the approximate beginning of systole to the approximate beginning of diastole.

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Introduction CR-2000 Research System Description The ‘A’ parameters are determined by a curve fitting approach and a proprietary selection procedure for determining the appropriate set of ‘A’ parameter values. Once the A2, A4 and A5 parameters are determined and R is calculated, the above equations can be used to determine C1, C2 and L. The values for C1 (Large Artery Elasticity Index) and C2 (Small Artery Elasticity Index) shown in the CardioVascular Profile Report are actually a weighted average of the individual beats used in the analysis. The value of Systemic Vascular Resistance shown in the Profile Report is expressed in units of dyne•sec•cm-5. A units conversion factor of 80 is multiplied by MAP(mmHg)/CO(Liters/min) to obtain R in units of dyne•sec•cm-5. L is in units of mmHg•sec2/ml and together with C1 and C2 is used to calculate the Total Vascular Impedance (TVI) which is the final value shown on the Report. The TVI is determined from the modified Windkessel model. Specifically, the Total Vascular Impedance is defined as the impedance calculated at the heart rate of the subject being measured. Thus the Total Vascular Impedance is calculated as the impedance function of the modified Windkessel model evaluated at the frequency of the measured heart rate and is calculated as follows:

Overview of Parameters in the Research CardioVascular Profile Report Since values for blood pressure are determined independently by the CR-2000 Research System using the (a) oscillometric method (reported in the Research CardioVascular Profile Report) and by (b) a waveform analysis approach (used to calculate Systemic Vascular Resistance and to estimate Cardiac Output), apparent discrepancies may occasionally arise. That is, by multiplying Pulse Rate times Stroke Volume to estimate Cardiac Output, or by dividing Mean Arterial Pressure by Cardiac Output to calculate Systemic Vascular Resistance, the results may yield slightly different values than those presented in the Research CardioVascular Profile Report. Therefore, the degree to which the oscillometric method and waveform analysis approach differ in determining these values will dictate the degree to which there is an apparent discrepancy in the values shown on the printed Profile Report.

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Introduction CR-2000 Research System Description Both the Large Artery or Capacitive Compliance value and the Small Artery or Oscillatory/Reflective Compliance value are expressed in traditional units of milliliters divided by millimeters of mercury (that is, a volume divided by a pressure). However, the actual values for these compliance values would then be shown in decimal fractions instead of whole numbers which are easier to remember and record. Therefore, the CR-2000 Research System has been programmed to present arterial elasticity indices in the Research CardioVascular Profile Report. The Large Artery Elasticity Index is simply the Capacitive Arterial Compliance in ml/mmHg multiplied by 10, and the Small Artery Elasticity Index is simply the Oscillatory or Reflective Arterial Compliance in ml/mmHg multiplied by 100. In order to avoid any confusion, the explanation of how these indices are derived is shown on the report.

Selected Clinical Research References During the past decade, there have been many scientific articles published in peerreviewed medical journals which have utilized the basic “pulse contour analysis” technology incorporated into the CR-2000 Research System. The user of the CR2000 Research System is encouraged to review and consider these articles in preparation for conducting their clinical research studies. A current bibliography of such articles involving the CR-2000 Research System technology is available from Hypertension Diagnostics, Inc.

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Introduction Component Descriptions

Component Descriptions B A

C

E

F D I

G

H J Figure 1-1. Components of the HDI/PulseWave™ CR-2000 Research CardioVascular Profiling System

Components of the HDI/PulseWave™ CR-2000 Research CardioVascular Profiling System A. The CardioVascular Profiling Instrument Enclosure B. Main Electrical Power Cord (Hospital Grade) C. Printer Electrical Power Cord (from CR-2000 System to Printer) D. Adjustable Handle / Stand E. Parallel Printer Data Cable F.

Ink-Jet Printer

G. Arterial PulseWave™ Sensor secured within a Sensor Holding and Positioning Device with Cable Assembly (connected to the CR-2000 Instrument) H. Wrist Stabilizer I.

Blood Pressure Cuff Hose

J.

Blood Pressure Cuffs (in three sizes: small, regular and large adult)

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Introduction Component Descriptions

Research CardioVascular Profiling Instrument The CR-2000 Research CardioVascular Profiling Instrument incorporates a touch sensitive screen, a microprocessor with preinstalled software, and an adjustable locking handle. It is fitted with a hospital-grade electrical power supply unit which automatically adjusts for worldwide voltages (the user needs only use the correct electrical power cord for his/her country). With the exception of the pump which inflates the blood pressure cuff, there are no moving parts in the instrument (not even a fan), therefore AIR VENTS MUST BE KEPT CLEAR TO DISSIPATE HEAT. The touch-sensitive screen and electroluminescent display exhibit clinical research information collected and calculated by the CR-2000 Research Instrument. User options are provided in text that is highlighted or framed on the screen which may be referred to as “hot buttons.” Internal to the CR-2000 Research Instrument is a single, small battery which maintains the clock (that is, date and time) when the unit is turned off. It is anticipated that this battery will operate for many years without replacement. However, when it does require replacement, such cannot be accomplished by the user. Only a factory or field technician authorized by Hypertension Diagnostics, Inc. may service the CR-2000 Research Instrument to replace the battery. The adjustable locking handle allows the monitor to be easily carried. The handle also serves as an adjustable stand for the CR-2000 Research Instrument, allowing the user to view the screen from one of several angles.

Wrist Stabilizer The Wrist Stabilizer is made of rigid plastic material shaped to conform to the contours of a human research subject's hand, wrist and forearm. It is positioned on the research subject using two hook-and-loop straps. The Wrist Stabilizer is designed to gently immobilize the wrist and to stabilize the radial artery such that it is readily accessible for placement of the Arterial PulseWave™ Sensor. The use of a Wrist Stabilizer is mandatory so as to minimize wrist movement during data collection and thereby improve the signal to noise ratio for optimal test results. Caution: The use of the CR-2000 Research System is contraindicated if the research subject is unable or unwilling to allow the user to place a Wrist Stabilizer on the subject’s wrist.

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Introduction Component Descriptions

Arterial PulseWave™ Sensor The Arterial PulseWave™ Sensor is fabricated using medical-grade stainless steel material. The Sensor canister is approximately 1/2 inch in diameter with a 0.006 inch thick diaphragm on the end that is positioned on the surface of a research subject's skin overlying the radial artery by the wrist. Internal to the Sensor, a piezoelectric element and associated circuitry are installed to collect and amplify the blood pressure waveform signal. The electrical current to power this circuitry as well as the transmission of the waveform signal from the Sensor to the CR-2000 Research Instrument is accommodated by a Sensor cable assembly integrated into the Sensor and connected to the CR-2000 Research Instrument with a metal connector.

Sensor Holding and Positioning Device The Arterial PulseWave™ Sensor is attached to the Sensor Holding and Positioning Device via a manually adjustable shaft which is central to the Device. Once the Wrist Stabilizer is positioned on a research subject, the Device, which has soft rubber feet, is carefully positioned on the wrist so as to be on either side of the radial artery. The Device is securely held in place by means of a hook-andloop strap placed around both the Wrist Stabilizer and the wrist. The Device allows the user to position the Sensor along the longitudinal axis of the radial artery as well as perpendicular to same. It is necessary to position the Arterial PulseWave™ Sensor on the area of the maximum radial artery pulsation. Typically, this is adjacent to the base of the research subject’s thumb in a location between the distal, lateral bony prominence of the radius bone (also known as the styloid process) and tendons medial to same. By carefully placing the Device and the attached Sensor, and by adjusting the hold-down pressure by rotating the knob on top of the Device, the user will be able to optimize the blood pressure waveforms generated from the subject's radial artery.

Three Adult Blood Pressure Cuffs Three adult sized blood pressure cuffs are supplied with the CR-2000 Research System. These are Calibrated ®V-Lok® cuffs with latex-free, silicone-free, neoprene-based inflation bags. Each cuff includes a short length of attached blood pressure hose with a metal luer lock connector. The three cuffs are color coded as follows: GREEN - Small adult sized cuff, fits limb circumferences from 7-1/8 to 10-1/4 inches (18 to 26 cm.) BLUE - Regular adult sized cuff, fits limb circumferences from 9-7/8 to 13-3/4 inches (25 to 35 cm.) RED - Large adult sized cuff, fits limb circumferences from 13 to 18-1/2 inches (33 to 47 cm.)

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Introduction Component Descriptions The user must observe the range indication markers on the inside of the cuffs supplied with the CR-2000 Research System to ensure that the correct size cuff is used on each subject. Details on cuff sizes and their accurate use are available in the Measuring Blood Pressure Section of this manual. Note: It is important to use the appropriate size blood pressure cuff. A cuff that is not the appropriate width for a subject’s arm circumference will cause an error in blood pressure measurement. Caution: No blood pressure cuff other than one of the three cuffs supplied with the CR-2000 Research CardioVascular Profiling System is acceptable for use with the Instrument. These supplied cuffs have been calibrated and tested to perform appropriately with the blood pressure module incorporated within the Instrument. Use of any other blood pressure cuff may yield inaccurate measurements.

Ink-Jet Printer An Ink-Jet Printer is included with the CR-2000 Research CardioVascular Profiling System. Use the printer to print Research CardioVascular Profile Reports only with a standard black ink cartridge and good quality paper. The printer power cord and data cable supplied with the CR-2000 Research System must be properly connected to the Instrument in order to print Profile Reports.

Cords / Cables Four (4) cords / cables and a blood pressure cuff hose must be connected to the CR-2000 Research Instrument before use. See the Setting Up Section for more details on the cords and cables used with the CR-2000 Research System. Two (2) electrical power cords are provided with the HDI/PulseWave™ CR-2000 Research CardioVascular Profiling System: 1. The Main Electrical Power Cord is approximately ten feet (366 cm.) long. This cord is hospital grade and connects into the three-prong connector on the rear panel of the CR-2000 Research System and to a U.S. standard, threeprong (grounded) electrical power outlet (or to an outlet in any country using the appropriate electrical power cord). This cord provides electrical power to both the CR-2000 Research Instrument and the Printer. 2. The Printer Electrical Power Cord connects to the rear panel of the CR-2000 Research Instrument in the small DC outlet identified as PRINTER POWER. The other end of the Printer Power Cord connects to the back of the Printer in the round power connector plug. The connectors on the Printer Electrical Power Cord are similar, and the user must be careful in making the correct connections. The end of the Cord which is colored black connects to the rear panel of the CR-2000 Research Instrument. The other end, which has a bright yellow color, connects to the Printer.

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Introduction Component Descriptions Two (2) other cables and a hose must be properly connected to the rear panel of the CR-2000 Research Instrument: 3. The Blood Pressure Cuff Hose is approximately ten feet (366 cm.) in length and connects to the rear panel of the CR-2000 Research Instrument at the metal luer lock connector identified as CUFF. The other end of the hose connects to the short length of hose on one of the three Blood Pressure Cuffs using the metal luer lock connector. 4. A Parallel Printer Data Cable connects the CR-2000 Research Instrument to the Printer. Both ends of the parallel printer cable have large flat connectors which must be matched to the appropriate connectors on the rear panel of both the CR-2000 Research Instrument and the Printer. 5. The Arterial PulseWave™ Sensor connects to the rear panel of the CR-2000 Research Instrument in the metal connector identified as SENSOR. At the other end, this cable is permanently attached to the Arterial PulseWave™ Sensor (which is attached to and assembled within the Sensor Holder).

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