Operators Manual
112 Pages
Preview
Page 1
Contents Introduction ... 7 The SphygmoCor XCEL Central Blood Pressure Measurement System ... 7 The SphygmoCor XCEL Pulse Wave Velocity Measurement System ... 7 Indications for Use ... 7 Intended Patient Population... 7 Intended Environment ... 7 Contraindications ... 8 Warnings ... 8 SphygmoCor XCEL PWA Quick Start Guide ... 9 SphygmoCor XCEL PWV Quick Start Guide ... 13 Recording a PWA Measurement ... 17 Components and Accessories for PWA ... 17 Connect Components ... 19 Start a Measurement ... 20 Automatic versus Manual Waveform Capture ... 24 Using the Guidance Bars ... 24 Reviewing the PWA Report ... 25 Deleting Reports ... 26 Repeat the measurement ... 27 Print the report ... 27 Quality Control Report (QC) ... 27 PWA Report Types ... 28 Clinical ... 28 Detailed ... 32 Reference Range ... 36 Wave Reflection ... 39 Viewing PWA Reports ... 41 Analysis of Multiple PWA Reports for the Same Patient ... 41 Techniques for Obtaining Quality PWA Measurements ... 42 Control Conditions ... 42 Cuff Placement ... 42 Recording a PWV Measurement ... 43 Components and Accessories for PWV ... 43 Connect Components ... 45 Start the Measurement ... 45 Reviewing the PWV Report ... 49 Deleting Reports ... 50 Repeat the Measurement ... 50 Return to Patient List ... 50 Viewing Multiple Reports with the Analysis Screen ... 51 Viewing PWV Reports ... 51 Printing PWV Reports ... 51 Printed PWV Report Example ... 52 Automatic versus Manual Waveform Capture ... 53 Using the Guidance Bars ... 53 Techniques for Obtaining Quality PWV Measurements ... 54 Fitting the femoral cuff ... 54 Control Conditions ... 56 Tonometer Technique ... 56 System Installation and Setup ... 57 Unpacking ... 57 Software Download ... 57
Software Installation ... 58 Standard Installation ... 58 Custom Installation ... 62 Uninstallation and Repair ... 65 Uninstallation ... 65 Repair ... 67 Deleting or Importing SphygmoCor CvMS Database ... 69 Deleting SphygmoCor CvMS Database ... 69 Starting SphygmoCor XCEL software ... 69 System Settings ... 71 General Settings ... 72 PWV Settings ... 77 PWA Settings ... 78 Brachial BP Settings ... 80 SphygmoCor XCEL Device Status Indications ... 81 Creating and Managing Patient Records ... 82 To locate a patient record ... 82 To create a new patient record: ... 83 Editing an Existing Patient ... 83 Deleting a Patient ... 84 Troubleshooting ... 86 SphygmoCor XCEL Device ... 86 Software Screens ... 86 Capture Screen ... 87 The Tonometer fails to respond. ... 87 Error Codes ... 87 Maintenance ... 92 Database Manager ... 92 Backup a Database ... 93 Restore a Database ... 94 Basic System Care ... 94 Equipment Calibration ... 95 Cleaning Instructions ... 96 PWA Brachial Cuff Care ... 98 Reference Information ... 98 Electromagnetic Compatibility (EMC) Warnings & Declarations ... 99 Technical Specifications ... 101 Physical and Environmental Specifications ... 101 Maximum Intended Design Life ... 101 Recommended Minimum Computer Requirements ... 102 Classification of SphygmoCor System ... 102 Standards ... 103 Explanation of Parameters/Indices ... 104 Warranty ... 106 Product Support ... 106 Safety Warnings ... 106 Medical Equipment Systems Compliance Warnings ... 106 General Safety Warnings ... 107 USA Privacy Rule ... 107 Cybersecurity ... 107 Disposal ... 107 Appendix ... 109 Installing SphygmoCor XCEL in a Networked Configuration ... 109 Preparation ... 110 Installing Microsoft SQL Server and AtCor Database on the Server... 110
Installing SphygmoCor XCEL on each Client ... 111 Connecting to network database using SphygmoCor XCEL ... 111 Installing Recommended Fonts on Different Versions of Windows ... 112 Windows 7 and Windows 8... 112 Windows 10 ... 112
Copyright SphygmoCor® XCEL Pulse Wave Analysis Measurement Pulse Wave Velocity Measurement Copyright © 2022 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: 101838 Manual Revision: 13.0 SphygmoCor® XCEL Software Version: 1.3 Patents: http://atcormedical.com/about/intellectual-property/ Head Office: AtCor Medical Pty Ltd Suite 301, 55 Lime St Sydney NSW 2000 Australia Telephone: + (61) 2 9874 8761 Email: inquiry@atcormedical.com Web: www.atcormedical.com USA Office and US FDA Agent: AtCor Medical, Inc. (USA) 184 Shuman Blvd Suite 515 Naperville, IL 60563 USA Telephone: + (1) 630 228 8875 Email: atcorusa@atcormedical.com European Authorised Representative:
Advena Ltd Tower Business Centre 2nd Flr. Tower Street Swatar, BKR 4013 Malta Telephone: +44 (0) 1926 800 153
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 Windows 7, 8 or 10 Operating Systems. If the operator is not familiar with the Windows environment, please refer to the Windows User Manual or Windows Online Help.
Trademarks “SphygmoCor®” is a registered trademark of AtCor Medical Pty Ltd. Millar, IBM, IBM PC, Microsoft, Windows, Excel and InstallShield 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
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.
Page 7
Contraindications •
The SphygmoCor XCEL System should not be used for patients with erratic, accelerated or mechanically controlled irregular heart rhythms, including patients with arrhythmias.
•
Do not use the SphygmoCor XCEL System on patients with carotid or aortic valve stenosis.
•
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.
•
On hypotensive patients, the device should be used with caution.
•
The system is not applicable in generalised constriction or localised spasm of muscular conduit arteries such as seen immediately after hypothermic cardiopulmonary bypass surgery or accompanying Raynaud's phenomena or intense cold.
•
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.
•
Do not use the cuff over a wound as this may cause further injury.
•
Do not place the cuff on any limb being used for intravenous access or where an arterio-venous (AV) shunt is present, or any area where circulation is compromised or has potential to be compromised and could result in injury to the patient
•
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.
•
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.
•
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 nonvalidated components may not be accurate,
•
Do not use the Tonometer on moist or wet skin.
•
Do not put objects on top of the SphygmoCor XCEL device that can obstruct access to the Stop Button.
•
Continuous CUFF pressure due to connection tubing kinking, result in continuous disruption blood flow may cause harmful injury to the patient.
•
Too frequent cuff PWA measurements can cause injury to the patient due to blood flow interference
•
Do not modify this equipment without authorisation of the manufacturer.
•
Temperature of tonometer and cuff may rise above 41 degree Celsius if operating device at maximum operating ambient temperature.
•
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 8
•
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 Download The SphygmoCor XCEL software installation media can be downloaded from the AtCor Medical website. 1. 2. 3. 4. 5.
Open atcormedical.com in your web browser. Navigate to the Customer Support section. Create an account. You will now have access to the XCEL Software, User Manual and Inservice videos. To download the required files, right click on each file and select ‘Save link as’. Save the files to your local drive. 6. To open the XCEL Software zip file, right click on the zip file and extract all files to your PC. Software Installation on Page 57 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. Note: If the following error (Code=3251) appears after starting the SphygmoCor XCEL software, refer to Installing Recommended Fonts on Different Versions of Windows section in the Appendix.
Page 9
3. Creating a Patient Record a) Click New to add a new patient record, or go to b if it is the first patient record.
b) Enter all mandatory data, indicated by the * symbol next to the field. Note: Before creating a new patient entry, check whether the patient already exists in the database. Separate patient entries cannot be merged. c) Click Save. 4. Recording a PWA Measurement Note: Minimise the patient's limb movement while capturing data. Movement may prevent the capture from being completed or may reduce the quality of the measurement. a) Select PWA (this is only necessary if you also have a license for PWV).
Page 10
b) Select the patient (search for the record if necessary)
c) Click Start. The cuff is inflated to measure patient’s brachial systolic pressure (SYS), diastolic pressure (DIA) and pulse pressure (PP) which will be displayed. During a BP assessment, the pressure is shown both with a bar, and a numerical value on the right side of the screen.
Note: If the multiple brachial BP assessments option is selected in the Brachial BP setting, the last displayed brachial SYS, DIA and PP will be the average values of the successfully completed assessments. Five seconds after the cuff deflation, the PWA measurement starts automatically.
Page 11
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 can either start the PWA measurement manually by clicking the Capture button or can 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 clicking the Cancel button on the screen, manually pressing the Stop button on top of the SphygmoCor XCEL device or turning off the SphygmoCor XCEL device. 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 the central aortic pressure waveform and parameters. Refer to the Using the Guidance Bars section on page 24 for explanation of the bars in the capture screen.
Page 12
Note: If the report screen does not display after 20 seconds of recorded brachial cuff pulses, click the Capture button to produce a report.
Refer to Reviewing the PWA Report section on page 25 for an explanation of the report screen displayed parameters. e) Click Print for a single-page summary report or click Print Patient Report for a multi-page patient report. The patient report may not be available in some regions. f)
Click Repeat to repeat the measurement on the same subject.
g) 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 Download The SphygmoCor XCEL software installation media can be downloaded from the AtCor Medical website. Page 13
7. Open atcormedical.com in your web browser. 8. Navigate to the Customer Support section. 9. Create an account. 10. You will now have access to the XCEL Software, User Manual and Inservice videos. 11. To download the required files, right click on each file and select ‘Save link as’. Save the files to your local drive. 12. To open the XCEL Software zip file, right click on the zip file and extract all files to your PC. Software Installation section on Page 57 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. 3. Creating a Patient Record a) Click New.
b) Enter all mandatory data, indicated by the * symbol next to the field. Note: Before creating a new patient entry, check whether the patient already exists in the database. Separate patient entries cannot be merged. c) Click Save. 4. Recording a PWV Measurement Note: Minimise 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 the setup screen.
Page 14
b) Select Mode - PWV.
c) Select the patient’s record. d) Enter the distance in millimetres from the patient’s carotid artery to their sternal notch (Carotid to Sternal Notch) and also the distance from their sternal notch to the top edge of the femoral cuff (Sternal Notch to Cuff).
Note: The femoral to cuff distance 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 use this value instead of the default. Refer to PWV Settings section on page 77 for details on distance measurements. e) Click Capture. f)
The cuff will be inflated to capture femoral waveform, and the carotid signal should be measured using the tonometer. When both signals are of “good” quality, both signals turn green and a PWV report is produced.
Page 15
The cuff can be deflated at any time by clicking the Cancel button on the screen, manually depressing the Stop button on top of the SphygmoCor XCEL device or by turning off the SphygmoCor XCEL device. 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 the calculated pulse wave velocity (PWV) and pulse transit time. Refer to Reviewing the PWV Report section on page 49 for an explanation of the parameters displayed in the report screen. Note: If the report screen does not appear for over 20 seconds of continuous simultaneous recording of carotid and femoral pulses, click the Capture button to produce a report.
Page 16
h) Click Print for a single-page report or Print Patient Report for a multi-page patient report. The patient report may not be available in some regions. i)
Click Repeat to repeat the measurement on the same subject.
j)
Click Delete to delete the report.
Recording a PWA Measurement Components and Accessories for PWA SphygmoCor XCEL device – the SphygmoCor microprocessorcontrolled module for data capture and analysis. Refer to SphygmoCor XCEL Device Status Indications for an explanation of the panel indicators.
Page 17
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: 1-011910877 - Medical Power Adaptor (Mean Well – PN GSM36B15-R7B) USB cable (2m) - connects the SphygmoCor XCEL device to a PC or laptop. Part number: 1-00858 - USB Cable 2m
Page 18
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.
Page 19
Start a Measurement Note: The patient's limb movement should be minimised while capturing data as movement may prevent the capture from being completed or may reduce the quality of the measurement. 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 entry box.
Page 20
4. Click Start. The cuff is inflated on the right of the screen, to measure brachial systolic and diastolic pressure. During a BP assessment, the pressure is shown both with a bar, and a numerical value on the right side of the screen.
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.
Page 21