SphygmoCor XCEL System v1 Operators Manual Ver 1.2 Rev 8.0 April 2012

Software Installation... 49 Preparing to Install SQL Server ... 50 Software Upgrade ... 62 Starting SphygmoCor XCEL software ... 63 System Settings ... 64 General Settings ... 65 PWV Settings ...66 PWA Settings ...68 Brachial BP Settings ... 69 SphygmoCor XCEL Device Status Indications ... 70 Creating and Managing Patient Records ... 72 To locate a patient record ... 72 To create a new patient record: ... 73 Editing an Existing Patient ... 73 Deleting a Patient ... 73 Troubleshooting ... 74 SphygmoCor XCEL Device... 74 Software Screens... 75 Capture Screen ... 75 The Tonometer fails to respond. ... 75 Error Codes...75 Maintenance ... 80 Database Manager ... 80 Backup a Database ... 80 Restore a Database ... 81 Basic System Care ... 82 Equipment Calibration ... 83 Cleaning Instructions ... 84 PWA Brachial Cuff Care ...85 Reference Information ... 86 Electromagnetic Compatibility (EMC) Warnings & Declarations ... 87 Technical Specifications ... 91 Physical and Environmental Specifications ... 91 Maximum Intended Design Life ... 91 Minimum Computer Requirements ... 92 Classification of SphygmoCor System ... 92 Standards ... 93 Explanation of Parameters/Indices ... 94 Warranty ... 96 Product Support ... 96 Safety Warnings ... 96 Medical Equipment Systems Compliance Warnings ... 96 General Safety Warnings ...97 USA Privacy Rule ... 97 Cybersecurity ... 97 Disposal ... 97 European Declaration of Conformity... 98

Copyright SphygmoCor® XCEL Pulse Wave Analysis Measurement Pulse Wave Velocity Measurement Copyright © 2012 AtCor Medical Pty. Ltd., Sydney Australia. All rights reserved. Under the copyright laws, this manual cannot be reproduced in any form without prior written permission of AtCor Medical Pty. Ltd. DCN: 101335 Manual Revision: 8.0 SphygmoCor® XCEL Software Version: 1.2 Head Office: AtCor Medical Pty Ltd West Ryde Corporate Centre Suite 11, 1059-1063 Victoria Rd. West Ryde NSW 2114 Sydney, Australia Telephone: + (61) 2 9874 8761 Facsimile: +(61) 2 9874 9022 Email: inquiry@atcormedical.com Web: www.atcormedical.com USA Office and US FDA Agent: AtCor Medical Inc One Pierce Place, Suite 255W-, Itasca, IL, 60143, USA Telephone: + (1) 630 228 8871 Facsimile: + (1) 630 228 8872 Email: atcorusa@atcormedical.com European Authorized Representative:

Advena Ltd Thorne Widgery House 33 Bridge Street Hereford HR4 9DQ United Kingdom Telephone: + (44) 845 094 3307 Facsimile: + (44) (0) 156 862 0078

Disclaimer This manual has been validated and reviewed for accuracy. The instructions and descriptions it contains are accurate for the AtCor Medical product models at the time of this manual’s production. However, succeeding models and manuals are subject to change without notice. AtCor Medical assumes no liability for damages incurred directly or indirectly from errors, omissions or discrepancies between the product and the manual. This Manual is produced on the assumption that the operator is an experienced user of the Windows XP/ Windows 7/ Windows 8 operating Systems. If the operator is not familiar with Windows operations, please refer to the Online Help of Windows or the Windows User Manual.

Trademarks “SphygmoCor®” is a registered trademark of AtCor Medical Pty Ltd. Millar, IBM, IBM PC, Microsoft, Windows and Excel are the registered trademarks of their respective holders.

Caution Federal (USA) law restricts this device to sale by or on the order of a physician

Medical Equipment CAN/CSA-C22.2 No. 601.1, UL 60601-1, CAN/CSA-C22.2 No. 60601-1 (2008), ANSI/AAMI ES60601-1 (2005), IEC 80601-2-30, CAN/CSA-C22.2 No. 80601-2-30 E310197 E465822

Introduction The SphygmoCor XCEL Central Blood Pressure Measurement System The SphygmoCor XCEL System is a non-invasive diagnostic tool for the clinical assessment of central blood pressure. The SphygmoCor XCEL System derives the central aortic pressure waveform from cuff pulsations recorded at the brachial artery. Analysis of the waveform provides key parameters including central systolic pressure, central pulse pressure and indices of arterial stiffness such as augmentation pressure and augmentation index. Increased central systolic pressure and augmentation index have been shown to be markers of cardiovascular risk.

The SphygmoCor XCEL Pulse Wave Velocity Measurement System The SphygmoCor XCEL System also measures the pulse wave velocity of the arterial pulse waveform travelling through the descending aorta to the femoral artery. The aortic pulse wave velocity is detected from carotid and femoral arterial pulses measured non-invasively and simultaneously. The carotid pulse is measured using the tonometer while the femoral pulse is measured through pulsations in a cuff placed around the thigh. Higher carotid to femoral pulse wave velocity indicates a stiffer aorta, which is an indicator of target organ damage.

Indications for Use The SphygmoCor® XCEL System provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. These measurements are provided non-invasively through the use of a Brachial cuff. It is to be used on those patients where information related to ascending aortic blood pressure is desired but the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits. Additionally, the SphygmoCor® XCEL System automatically measures Systolic blood pressure and Diastolic blood pressure. The SphygmoCor® XCEL Pulse Wave Velocity (PWV) option is intended to obtain PWV measurements. The PWV option is used on adult patients only.

Intended Patient Population The SphygmoCor® XCEL System is intended to be used on adult patients only. Do not use on neonates. Safety and effectiveness in children under the age of 18 years of age and neonates have not been established.

Intended Environment The SphygmoCor® XCEL System is intended to be used in a Clinical or Research environment. The SphygmoCor XCEL System is intended to be used temporarily as a cardiovascular diagnostic tool. It is not intended to be used as a continuous monitoring device in hospital or emergency vehicle, and is not applicable to be classified as a defibrillation-proof applied part. The SphygmoCor XCEL system is not intended for use during patient transport outside of a healthcare facility.

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Contraindications •

The SphygmoCor XCEL System should not be used for patients with erratic, accelerated or mechanically controlled irregular heart rhythms, including patients with arrhythmias.

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Do not use the SphygmoCor XCEL System on patients with carotid or aortic valve stenosis.

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The device should not be used on patients with peripheral artery disease PAD or leg artery disease since an applied cuff pressure on the leg of these subjects may be harmful.

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On hypotensive patients, the device should be used with caution.

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The system is not applicable in generalised constriction or localized spasm of muscular conduit arteries such as seen immediately after hypothermic cardiopulmonary bypass surgery or accompanying Raynaud's phenomena or intense cold.

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Any interpretations made from the SphygmoCor XCEL System measurements should be made in conjunction with all other available medical history and diagnostic test information about a patient.

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Do not use the cuff over a wound as this may cause further injury.

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Do not place the cuff on any limb being used for intravenous access or where an arterio-venous (A- V) shunt is present, or any area where circulation is compromised or has potential to be compromised and could result in injury to the patient

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It is advisable for patients with mastectomy not to perform measurement with the cuff on the side of mastectomy as it may cause harmful injury to the patient.

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The user need to check that application of the cuff do not result in prolonged impairment of patient blood circulation

Warnings •

Do not use mobile/cellular phones or other transmitting devices within 10 meters (30 feet) of the SphygmoCor XCEL System.

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Use only with the tonometer, cuffs and air hose supplied by AtCor Medical. Different tonometers, hoses and cuffs have not been validated with SphygmoCor XCEL and measurements with non validated components may not be accurate,

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Do not use the Tonometer on moist or wet skin.

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Do not put objects on top of the SphygmoCor XCEL device that can obstruct access to the Stop Button.

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Continuous CUFF pressure due to connection tubing kinking, result in continuous disruption blood flow may cause harmful injury to the patient.

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Too frequent cuff PWA measurements can cause injury to the patient due to blood flow interference

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Do not modify this equipment without authorisation of the manufacturer.

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Temperature of tonometer and cuff may rise above 41 degree Celsius if operating device at maximum operating ambient temperature.

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To disconnect from the supply mains, the power adaptor needs to be unplugged from the mains socket. Ensure the device is positioned such that the power adaptor plug (supply mains side) is not obstructed during use Page 7

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Note: additional warnings printed on the SphygmoCor XCEL device and at the end of the Manual.

SphygmoCor XCEL PWA Quick Start Guide This Quick Start Guide is based on default software options for SphygmoCor XCEL. Changing from default settings may result in different menu options. 1. Software Installation Note: Make sure that the SphygmoCor XCEL device is NOT connected during the software installation. Refer to section Software Installation on Page 49 for instructions to install the XCEL software. 2. Hardware Installation a) Connect the power supply to the SphygmoCor XCEL device and plug in the power supply into a mains socket. WARNING: Do not connect any power supply to the SphygmoCor XCEL device other than the one provided by AtCor. b) Connect the SphygmoCor XCEL device to your PC using the USB cable. c) Connect the brachial cuff to the SphygmoCor XCEL device. d) Switch on the SphygmoCor XCEL device. e) Fit the cuff to the patient f)

Start the SphygmoCor XCEL software by double-clicking on the SphygmoCor XCEL software icon on the desktop.

3. Creating a Patient Record a) Click New.

b) Enter all mandatory data, indicated by the * symbol next to the field. c) Click Save. 4. Recording a PWA Measurement Note: Minimize the patient's limb movement while capturing data. Movement may prevent the capture from being completed or reduce the quality of the measurement. a) Select PWA (this is only necessary if you also have a license for PWV).

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b) Select the patient (search for the record if necessary)

c) Click Start. The cuff is inflated, as indicated by the bar on the right of the screen, to measure patient’s brachial systolic pressure (SYS), diastolic pressure (DIA) and pulse pressure (PP) which will be displayed.

Note: If the multiple brachial BP assessments option is selected in the Brachial BP setting, the displayed brachial SYS, DIA and PP will be the average values of the successfully completed assessments.

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Five seconds after the cuff deflation, the PWA measurement starts automatically Note: When using the multiple brachial BP assessments option, there may be occasions where not all Brachial BP assessments were performed successfully. On these occasions, the user either can start the PWA measurement manually by clicking the Capture button or start a new multiple Brachial BP assessment by clicking the Start button.

The cuff is inflated and the capture screen is displayed, showing the captured cuff waveform.

The cuff can be deflated at any time by either (a) pressing the STOP button on the screen (b) turning off or disconnecting power from the SphygmoCor XCEL device. The cuff can be removed at any time, even if it is inflated. Note: SphygmoCor XCEL inflates the cuff before each reading, then deflates the cuff. d) After 5 seconds the recorded cuff waveform will be automatically captured and a report screen will be displayed, showing central aortic pressure waveform and parameters. Refer to the Using the Guidance Bars section on page 21 for explanation of the bars in the capture screen. Note: If the report screen does not display after 20 seconds of recorded brachial cuff pulses, click the Capture button to produce a report.

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Refer to Reviewing the PWA Report section on page 23 for an explanation of the report screen displayed parameters. e) Click Print to print patient report (Clinical or Patient Summary report), (i) Click Repeat to repeat the measurement on the same subject, or (ii) Click Delete to delete the report.

SphygmoCor XCEL PWV Quick Start Guide This Quick Start Guide is based on default software options for SphygmoCor XCEL. Changing from default settings may result in different menu options. 1. Software Installation Note: Make sure that the SphygmoCor XCEL device is NOT connected during the software installation. Refer to Software Installation section on Page 49 for instructions to install the XCEL software. 2. Hardware Setup a) Connect the power supply to the SphygmoCor XCEL device and plug in the power supply into a mains socket. WARNING: Do not connect any power supply to the SphygmoCor XCEL device other than the one provided by AtCor. b) Connect the SphygmoCor XCEL device to your PC using the USB cable. c) Switch on the SphygmoCor XCEL device. d) Fit the cuff on the patient’s upper thigh. e) Start the SphygmoCor XCEL software.

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3. Creating a Patient Record a) Click New.

b) Enter all mandatory data, indicated by the * symbol next to the field. Click Save. Note: Before creating a new patient entry, check whether the patient already exists in the database. Separate patient entries cannot be merged. 4. Recording PWV Measurement Note: Minimize the patient's limb movement while capturing data. Movement may prevent the capture from being completed or reduce quality of the measurement. a) Go to setup screen. b) Select Mode - PWV.

c) Select the patient’s record. d) Enter on the right-hand side of your PC screen distance information. Enter Sternal Notch to Cuff (top edge)measurement, and Carotid to Sternal Notch measurement in mm.

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Note: Femoral to cuff value is set to 200mm by default. To improve the accuracy of the PWV reading, measure the distance from the top edge of the cuff to the femoral artery (near the groin) and enter the value instead of the default. Refer to PWV Settings section on page 66 for details on distance measurements e) Click Capture. f)

Measure carotid signal using the tonometer. When the signal quality is valid (the signal turn to green), the femoral cuff inflates automatically.

The cuff can be deflated at any time by either (a) pressing the STOP button on the screen (b) turning off or disconnecting power from the SphygmoCor XCEL device. The cuff can be removed at any time, even if it is inflated. Note: SphygmoCor XCEL inflates the cuff before each reading, then deflates the cuff. g) After 10 seconds of simultaneous valid carotid tonometer signal and femoral cuff signal, A report screen will appear showing both signals and calculated pulse wave velocity (PWV) and pulse transit time.

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Refer to Reviewing the PWV Report section on page 41 for understanding of the parameters displayed in the report screen. Note: If the report screen didn’t appear for 20 seconds of continuous simultaneous recording of carotid and thigh pulses, click the Capture button to produce a report.

h) Click Print to print patient report (Clinical or Patient Summary report), (i) Click Repeat to repeat the measurement on the same subject, or (ii) Click Delete to delete the report.

Recording a PWA Measurement Components and Accessories for PWA SphygmoCor XCEL device – the SphygmoCor microprocessor-controlled module for data capture and analysis. Refer to SphygmoCor XCEL Device Status Indications for an explanation of the panel indicators.

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Brachial cuff – a pneumatic cuff with a tube connection to the SphygmoCor XCEL device Part numbers: 1-00889 - Cuff PWA Adult Large 31-40cm 1-00890 - Cuff PWA Adult 23-33cm 1-00891 - Cuff PWA Adult Extra Large 38-50cm

Cuff Hose- 1.5m cuff hose with connectors at both ends. Part number: 1-00865 - Cuff Hose 1.5m

Power supply – an AC power adaptor for the SphygmoCor XCEL device. Always use the power supply provided by AtCor Medical Part number: 1-00877 - Medical Power Adaptor (Meanwell – PN MES30B-4R6B)

USB cable (2m) - connects the SphygmoCor XCEL device to a PC or laptop. Part number: 1-00858 - USB Cable 2m

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Tray (optional) – provides storage of cuffs, as well as a mounting platform for the SphygmoCor XCEL device (The storage tray is an optional component supplied by AtCor Medical). Part number: 1-00896 - EM4 Storage Tray

Connect Components Warning: Do not connect any power supply to the SphygmoCor XCEL device other than the power supply provided by AtCor Medical. 1. Connect the power supply to the SphygmoCor XCEL device and plug the power supply into an AC power outlet. 2. Connect the SphygmoCor XCEL device to the PC using the USB cable. 3. Connect the brachial cuff to the SphygmoCor XCEL device. 4. Power on the SphygmoCor XCEL device. Note: Avoid compression or restriction of the connection tubing

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Start a Standard Workflow Measurement Note: The patient's limb movement should be minimized while capturing data as movement may prevent the capture from being completed or reduce the quality of the measurement. The Standard Workflow option is set in the PWA Workflow category of General Settings. 1. Select PWA (this is only necessary if you also have a license for PWV).

2. Select the patient (by searching Patient ID, Name or Date of Birth, if necessary). If the patient does not exist in the database, create a new patient record by clicking New and entering the patient details. Mandatory fields are indicated by *.

3. To determine the patient’s SphygmoCor reference age, an estimate of the arterial age of the patient, enter the height of the patient in the height box.

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4. Click Start. The cuff is inflated, as indicated by the bar on the right of the screen, to measure brachial systolic and diastolic pressure.

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Brachial Systolic Pressure (SYS), Brachial Pulse Pressure (PP) and Brachial Diastolic Pressure (DIA) are displayed. If multiple Brachial blood pressure measurements are selected to calibrate the waveform, the Brachial BP measurement will be repeated and average values for brachial SYS, PP and DIA will be displayed.

After determining the Brachial Systolic and Diastolic pressure, the cuff will deflate. Five seconds later, the cuff will reinflate and automatically capture the PWA waveform. Note: During PWA waveform capture, the cuff can be deflated by either (a) pressing the STOP button on the screen (b) turning off or disconnecting power from the SphygmoCor XCEL device. The cuff can be removed at any time, even if it is inflated. The Capture screen displays the brachial waveform being collected from the cuff. The colour of the waveform along with vertical bar on the side becomes green when the waveform is consistent for capture. When the waveform colour and the side bar become green, the waveform will be automatically captured and the software will advance to the report screen. The waveform may also be captured manually by clicking the capture button at the bottom of the screen.

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5. If the Auto Capture feature is disabled, waveforms are captured by clicking the Capture button when it is enabled. The Capture button is enabled when the software detects a sufficient number of pulses to produce a valid report. Note: For best results, click the Capture button when the waveform colour and corresponding vertical bar are green, as shown in the following screen shot.

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A re eport screen is then displayed, showiing central aortic pressurre waveform m and parame eters for reviiew.

Refe er to Review wing the PWA A Report for a detailed exxplanation off this report and the Cen ntral presssure and arterial stiffneess measuress. 6. Clickk Print to print patient reeport. (Cliniccal or Patientt Summary re eport may bee selected. The T patient repo ort may not be b available in some cou untries). 7. Clickk Repeat to repeat r the measurement m t on the sam me subject 8. Clickk Delete to delete d the reeport

Autom matic verssus Manua al Wavefo orm Captu ure Waveform capture can be perfo ormed eitherr automaticaally or manuaally. •

If Au uto Capture is enabled (d default settin ng), the softw ware will auttomatically ccapture the waveform w wheen all of the q quality param meters are met. m Alternattively, the keeyboard spacce bar can be e pressed at any time to overrride the Autto Capture feeature and capture the waveform. w

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If Au uto Capture is disabled, data d capturee can be com mpleted by manually presssing the spacebar on the computer keeyboard whe en the Captu ure button is enabled, ind dicating enou ugh pulses have been orded to prod duce a valid report. reco

Using the Guida ance Barss When preparing to ccapture waveeforms, the SphygmoCorr XCEL System m provides ffeedback thaat will help m the brachial cuff are co onsistent eno ough to provvide an accurrate central determine if the wavveforms from P) measurem ment. blood prressure (CBP

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