Ambulo 2400 Users Guide

Ambulo 2400 ABPM System Configure the Ambulo 2400 for Each Patient The Ambulo 2400 must be programmed for each patient using the software. This should only take a few minutes. Connect the Ambulo 2400 to your PC using the included USB cable. Open the Hypertension Diagnostics Suite software. Using the Software Configuration menu, ensure that the COM port setting for the Ambulo 2400 matches the setup on your PC. See the User’s Guide for further information. Select an existing or create a new patient - including all relevant information. Click on the ‘Configure Device’ button. Select the ‘One Click Programming’ button if a Default Monitoring Plan has been defined. Alternatively, select ‘Configure Device Parameters’. As shown on the right, this will allow for entry of all measurement parameters, including monitoring periods and frequencies. Once ready, send this data to the device by clicking on the ‘Send Data to ABPM Device’ button. Configuration is now complete. You may disconnect the USB cable and begin patient set-up. The Ambulo 2400 will restart into PAUSE mode and should display the correct time. Press and hold the button for 5 seconds to change the device mode from PAUSE to AUTOMATIC. Once in AUTOMATIC mode, the device may display a countdown in addition to the time.

Quick Start Guide

Ambulo 2400 ABPM System Patient Set-up Select an appropriate-sized cuff, depending upon the size of the patient’s non-dominant arm. Each cuff is labeled with range markers to indicate the min and max circumference that can be accommodated by that cuff. Place the cuff on the patient’s non-dominant arm such that the artery indicator rests on the brachial artery. Do not tighten the cuff too firmly; allow a finger’s worth of slack between the cuff and the arm. The Ambulo 2400 can be worn in four distinct configurations, depending upon patient comfort and anticipated activity:

EasyWear™ Cuff

Shoulder Strap

Belt Clip

Asleep (Standard Cuff)

Quick Start Guide

Ambulo 2400 ABPM System Obtaining Measurements and Reporting Connect the Ambulo 2400 to your PC using the USB cable. Run the software. From the Main Menu, click the ‘Download Data from Device’ icon to obtain the data measurements from the ABPM unit. Review the Table, Graphical, Actigraphy, Histogram, Statistical, Comparison and Report views as needed. Enter any appropriate observations and analyses which should be included as part of the patient chart notes. This can be done from the Browse Patients icon, after selecting the patient and clicking the ‘Edit’ button. Print an ABPM data report by selecting the ‘Report View’ function. The format of the report can be determined in the Software Configuration menu. If you have any problems or need further information, please refer to the detailed instructions in the User’s Guide. You can obtain service and support by contacting your Customer Service Representative indicated in this document.

Quick Start Guide

Ambulo™ 2400 ABPM System User’s Guide

Copyright Notice © 2008-2009 - Tiba Medical, Inc. All Rights Reserved NO-WARRANTY – This technical information is being furnished to you AS-IS, and Tiba Medical makes no warranty as to its accuracy or use. Any use of the technical documentation or the information contained therein is at the risk of the user. Documentation may include technical or other inaccuracies or typographical errors. Tiba Medical reserves the right to make changes without prior notice. No part of this publication may be copied without the express written permission of Tiba Medical.

Trademarks Tiba Medical, Ambulo, Ambulo 2400, and EasyWear are trademarks of Tiba Medical, Inc. Windows®, Windows XP®, and Windows Vista ® are registered trademarks of Microsoft Corporation. Adobe and Acrobat are trademarks of Adobe Systems Incorporated. Other product names mentioned in this manual may be trademarks of their respective companies and are hereby acknowledged. Printed in the United States of America

Part Number: 810-0001-01

Product License This product and its accompanying software are subject to Tiba Medical’s End User License Agreement. By using this product and its accompanying software, you agree to the terms and conditions specified therein.

Additional Notices Portions of this product include software and components that are copyrighted by their respective owners including: AVR Libc Package Copyright © 1999-2007 The Regents of the University of California. All rights reserved. KISS FFT Package Copyright © 2003-2004 Mark Borgerding. All rights reserved. LPCUSB USB Device Driver for LPC Microcontrollers Copyright © 2006 Bertrik Sikken ([email protected]) All rights reserved. SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS AND CONTRIBUTORS "AS IS" AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING (BUT NOT LIMITED TO) THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE DISCLAIMED. IN NO EVENT SHALL THE COPYRIGHT OWNER OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION), HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY; WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE); ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.

Cautions, Notes and Other Symbols The following symbols are used throughout this User’s Guide to provide cautions, notes and warnings.

A CAUTION indicates a potential for inaccurate measurements, property damage or injury. CAUTION

A NOTE indicates important information that helps you make better use of your system. NOTE

The following explains the symbols indicated on the Ambulo 2400 device label:

! IPX1

Attention, consult accompanying documentation including this User’s Guide. Indicates the device has been tested for safety from vertically dripping water. Specifically, it indicates DRIP-PROOF, a higher than ORDINARY level of protection from drips, leaks, and spills. Safety classification of Type BF Applied Part Defibrillation Proof. The device or its applied parts have conductive contact with the patient for medium or long-term. Tested for safety by the Canadian Standards Association according to applicable US and Canadian standards and requirements. The CE Mark indicates conformance to the European Medical Device Directive.

Declaration of Conformity We,

Tiba Medical, Inc. 2701 NW Vaughn Street, Suite 470 Portland, Oregon 97210 USA

Declare and certify that the product described below is in conformity with the applicable provisions of Council Directive 93/42/EEC concerning medical devices. Ambulo 2400 Ambulatory Blood Pressure Monitoring System The product has been verified as conforming via the procedure relating to the Declaration of Conformity as set out in Annex II, excluding Section 4, of the European Directive.

____________________________ President

October, 1, 2008_______________ Date

Certification Registration No.: 409736 MR2

EC REP

EMERGO EUROPE Molenstraat 15 2513 BH, The Hague The Netherlands

0297

Contents INTRODUCTION ... 1 OVERVIEW ... 1 INDICATIONS FOR USE ... 1 THE ABPM PROCEDURE ... 1 THE AMBULO 2400 SYSTEM ... 1 FEATURES ... 2 AMBULO 2400 SYSTEM OVERVIEW... 4 SYSTEM COMPONENTS ... 4 ABPM DEVICE AT A GLANCE ... 5 LCD PANEL ... 5 AIR SOCKET ... 6 START/STOP BUTTON ... 7 INSERTING & REPLACING BATTERIES IN THE DEVICE ... 7 USB INTERFACE ... 10 SOFTWARE INSTALLATION ... 11 SOFTWARE REQUIREMENTS ... 11 INSTALLING THE SOFTWARE ... 11 REMOVING THE SOFTWARE ... 12 UPGRADING THE SOFTWARE ... 12 INSTALLING USB DRIVERS ... 13 SOFTWARE OPERATION... 15 STARTING THE PROGRAM ... 15 ENTERING PATIENT INFORMATION ... 16 Creating a New Patient... 16 Selecting a Patient ... 18 Editing Information on an Existing Patient ... 18 Deleting a Patient ... 18 Configuring Device... 19 Sequence Plan Example ... 26 Defining the Default Measurement Plan & One-Click Programming ... 28 Communication Port Setup ... 28 GETTING & VIEWING DATA MEASUREMENTS ... 30 Selecting a Study ... 31 Deleting a Study... 31 Viewing Complete Measurements ... 31 Adding Medication Information... 31 Software Configuration Menu... 32 TABLE VIEW ... 33 Excluding a Measurement Row... 34 Page i

Re-including a Measurement Row ... 34 Setting Asleep / Awake Time ... 34 Range Limits ... 35 Editing the Range Limits... 35 Adding Comments to Individual Measurements... 35 Other Table View Options... 35 GRAPHICAL VIEW ... 35 Graphing the BP Hourly Mean... 36 Bar Display Option ... 36 Diagram or Hide Pulse and MAP Measurements... 37 Scaling Up / Scaling Down / Scrolling ... 37 ACTIGRAPHY VIEW... 37 Changing the Asleep / Awake Cycle... 39 HISTOGRAM VIEW ... 39 STATISTICS VIEW... 40 COMPARISON VIEW ... 41 REPORT VIEW ... 43 Concise vs. Detailed Reports ... 44 Report Editor ... 44 Auto Summary... 44 ADDITIONAL OPERATIONS ... 44 Setting Institutional Information... 44 Performing Diagnostics ... 45 Import / Export of Patient Data ... 46 New / Open Database ... 47 User Management... 47 Changing a Password ... 48 Database Backup ... 48 Getting Help... 48 About the Software... 49 Closing the Program... 49 PERFORMING AN ABPM PROCEDURE ... 50 CONFIGURING THE ABPM DEVICE ... 50 PATIENT HOOK-UP ... 51 DOWNLOADING AND REVIEWING DATA MEASUREMENTS ... 55 CARE & MAINTENANCE ... 57 GENERAL CARE & MAINTENANCE ... 57 ELECTROMAGNETIC COMPATIBILITY (EMC)... 58 DEVICE CALIBRATION ... 58 TROUBLESHOOTING ... 62 POWER-ON ISSUES... 62 COMMUNICATION ERRORS ... 62 ABPM DEVICE NOT FUNCTIONING... 63 Page ii

ERROR & DIAGNOSTIC CODES ... 64 SPECIFICATIONS ... 66 SPARE PARTS, ACCESSORIES & SERVICE ... 69 GUIDANCE & MANUFACTURER’S DECLARATIONS ... 70 ELECTROMAGNETIC EMISSION ... 70 ELECTROMAGNETIC IMMUNITY ... 70 SEPARATION DISTANCE ... 73 ROHS & WEEE STATEMENT ... 74 RECYCLING POLICY ... 74 PRODUCT WARRANTY INFORMATION ... 75 WARRANTY TERMS & CONDITIONS... 75 WARRANTY REPLACEMENT COVERAGE ... 75 LIMITATIONS ... 75 CUSTOMER RIGHTS ... 76 OUTSIDE THE UNITED STATES ... 76 HOW TO OBTAIN SERVICE ... 76 EXTENDED COVERAGE ... 76 SOFTWARE LICENSE AGREEMENT ... 77 DEFINITIONS... 77 TITLE ... 77 COPYRIGHT... 77 LICENSE ... 78 Use of the Software ... 78 Restrictions ... 78 Trial ... 78 Import/Export Restrictions... 78 Term... 79 Termination... 79 U.S. Government End Users ... 79 European Community End Users... 79 Feedback... 79 Indemnification ... 80 LIMITED WARRANTY AND LIMITATION OF REMEDIES ... 80 LIMITATION OF LIABILITY ... 81 GENERAL... 82 Force Majeure ... 82 Governing Law... 82 No Agency ... 82

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Introduction Overview The Ambulo 2400 is a compact, non-invasive Ambulatory Blood Pressure Monitoring (ABPM) system. ABPM technology involves the use of an automatic, non-invasive device to measure blood pressure over an extended period of time – typically 24 hours. The ABPM procedure is an essential tool for physicians, clinical researchers, and other healthcare professionals to analyze a patient’s blood pressure as it relates to his/her circadian rhythm. This process offers insight into diagnostic factors as they relate to the spectrum of activity within everyday life.

Indications for Use The Ambulo 2400 Ambulatory Blood Pressure Monitor is designed to measure systolic and diastolic blood pressure and pulse rate of adults who are eighteen (18) years and older using the oscillometric method on a cuffed arm.

The ABPM Procedure Blood pressure naturally fluctuates throughout a full day according to various factors, including: sleep patterns, medication, diet, exercise, and stress. The science of ambulatory blood pressure monitoring has evolved from the problems associated with the inherent variability of a person’s blood pressure over time. Traditionally, the belief was that one average blood pressure reading was adequate for obtaining the information necessary for sound diagnosis and treatment. More recently-published literature, however, indicates that multiple blood pressure readings over an extended period of time often reveal unaccounted-for discrepancies that are simply unavailable and unacknowledged within a single measurement.

The Ambulo 2400 System The Ambulo 2400 ABPM system is lightweight, quiet, comfortable, and does not interfere with daily activities. It is easily configured and individually-fitted for each patient by a physician or nurse. The 24-hour measurements for systolic and diastolic blood pressure, the mean arterial pressure, and the pulse rate are automatically obtained without medical supervision, and later downloaded to a computer for analysis and interpretation. Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard for Electronics or Automated Sphygmomanometer (ANSI/AAMI SP10-2002). Page 1

Features • • • • • •

Precision: Utilizes a fast and highly-accurate Oscillometric algorithm based on patented digital signal-processing techniques. Actigraphy: Automatic categorization of asleep/awake cycles based on patented technology reduces cumbersome reliance on diaries. Ease of Use: Sophisticated and intuitive software interface for easy programming, data download, and report generation. Form Factor: Sleek, modern design that is compact, durable, and easy to use. EasyWear™ Options: Unit can be integrated onto the blood pressure cuff, clipped onto a belt, or strapped around the shoulder. Validation: Validated according to the AAMI SP-10 protocol and in accordance with the British Hypertension Society’s protocol.

Results of the ABPM procedure must be evaluated and interpreted by a trained and licensed healthcare practitioner. CAUTION

CAUTION

CAUTION

NOTE

The Ambulo 2400 system is designed for adults over the age of 18 years old. The performance and accuracy of the Ambulo 2400 has not been validated in children. The Ambulo 2400 system should NOT be used for measurement of blood pressure in neonates. The Ambulo 2400 system may not provide accurate results in patients who have arrhythmias such as atrial or ventricular premature beats or atrial fibrillation.

Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method, within the limits prescribed by the American National Standard, Manual, electronic, or automated sphygmomanometers. Page 2

NOTE

The efficacy and accuracy of the Ambulo 2400 system has been validated according to a number of standards, including AAMI SP-10:2002. Please contact your Customer Service Representative to obtain a copy and for details regarding the findings of such testing, as well as the accuracy claims of the system vs. that of trained observers.

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Ambulo 2400 System Overview System Components You system will include a number of components that are essential to carrying out successful ABPM procedures on a wide variety of patients. While exact configurations will vary depending upon what options you have chosen and where you purchased the system, it will generally include the following:

A

B

C

H

I

D

G

J Item A B C D E F G H I J K L

Quantity 1 1 1 1 1 1 1 1 2 1 1 1

Part Number 010-2400-01 008-0007-01 810-0001-01 008-0006-01 008-0005-01 008-0008-01 008-0009-01 008-0007-01 501-0002-01 008-0003-01 008-0002-01 008-0001-01

K

L

Description Ambulo 2400 ABPM Device Carrying Pouch with Belt Clip User’s Guide Extension Hose EasyWear™ Cuff USB Cable CD-ROM Software Shoulder Strap Rechargeable NiMH Batteries Large Adult Cuff Regular Adult Cuff Small Adult Cuff Page 4

In addition, you may have received a carrying case, disposable cuffs and/or Patient Information Sheets/Patient Diary Forms with your ABPM system. Please review the contents of your system to ensure that you have received all materials.

ABPM Device at a Glance

Air Socket

LCD Button

USB

Battery Door

LCD Panel

During initial power-up, all available segments of the LCD will be turned on to verify correct functionality of the display. Please note that not all available segments on the LCD are relevant to this device at any given time, and that they may be activated during different operations.

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Depending upon the mode of operation, the LCD panel will show any of the following items: • •

Current time. If the system is paused and not taking any measurements, the LCD will display PAUSE. If the system is in a measurement cycle, the LCD will display the current time and, depending upon how the device has been configured, the time remaining until the next measurement. If the system is in the process of taking a pressure measurement, the LCD may display the current pressure level (in mmHg) during the inflation/deflation cycle. If the system has completed the measurement, the LCD may display the results of the current measurement – including systolic and diastolic pressure alternating with the pulse rate, as indicated via the BPM segment – for a few seconds. Error messages, if any.

• • •

•

NOTE

Depending upon user configuration via the software, the LCD may NOT display any or all of the following: a) time remaining to next measurement, b) current pressure level, and/or c) results of a recent blood pressure measurement.

LCD Display PAUSE

Description Device is paused Indicates Beats per Minute (Pulse) AM (12:00 AM – 11:59 AM) PM (12:00 PM – 11:59 PM) Low battery

indicates that the Ambulo 2400’s batteries are low and need to be replaced/recharged. This indicator may only come on during cuff inflation, and immediately disappear afterwards. This action indicates that the Ambulo 2400 device has sufficient standby power, but not enough power to inflate/deflate the cuff. Once battery condition becomes extremely low, the LCD display will indicate “Lo Bat” and the device will be inoperative until the batteries have been replaced.

Air Socket The air socket is used for inflation of the blood pressure cuff. When using the device directly on the EasyWear cuff, connect the air socket to the mating hose of the cuff. If the device is not placed directly on the Page 6

EasyWear cuff, use the extension hose to connect the air socket and the blood pressure cuff. To attach, simply connect the hose to the air socket. To detach, pull away the hose from the air socket.

Start/Stop Button Press this button once to manually trigger a measurement. This function may be disabled via the software. During a measurement, whether triggered manually or automatically, press this button to immediately stop the measurement in progress and deflate the cuff. Press and hold the button for three seconds to put it in pause mode. In this mode, the LCD will alternate between displaying the current time and PAUSE. This function is necessary if the patient does not want measurements taken automatically. This could be the case if the 24-hour measurement period is complete, or if there is a need for a rest (e.g., bathing or changing clothes). If the device is in pause mode, press and hold the button for three seconds to return to automatic mode. Depending upon how the device is configured, the screen will alternate between showing the current time and the time remaining until the next measurement. In order to reset the Ambulo 2400 to go through its full-scale baseline measurement mode – from maximum pressure set all the way down to 45mmHg – press and release the button three consecutive times. The LCD display should then display “Hi <max pressure>,” where <max pressure> is the maximum pressure set on the device. This would be used in cases where wide fluctuations from the previously obtained values for systolic or diastolic are anticipated, such as after heavy exercise.

NOTE

Depending upon user configuration via the software, the button may be disabled. If this is the case, the user will not have control over manually-triggering a measurement. The user will still be able to stop a measurement in progress by pressing the button.

Inserting & Replacing Batteries in the Device To insert batteries, slide open the battery door on the back of the device. This is accomplished by pressing down firmly on the studded section of the door and firmly pushing away from the device. The correct battery polarity is indicated inside of the casing. To replace the cover once the batteries are inserted, slide it Page 7

along the side-rails until the tab on the top of the door clicks shut inside its housing. Once powered, the device will beep and the LCD will briefly indicate the current firmware version of the device followed by the current time of day. The device will then continue operating in its last known configuration.

When replacing the batteries, please remember the following important directions:

CAUTION

Install the batteries exactly as instructed in the diagram. Incorrect installation of the batteries with the wrong polarity may damage your ABPM device and may void your warranty.

Only use NiMH AA batteries; any other batteries may damage your ABPM device and may void your warranty. CAUTION

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For best results, only use fully-charged NiMH (Nickel-Metal Hydride) rechargeable batteries with the device. NOTE

The rechargeable NiMH batteries shipped with the device must be fully charged before use. NOTE

Do not mix different types of batteries – such as Alkaline disposables, NiMH and NiCD rechargeable batteries. CAUTION

CAUTION

It is recommended that new batteries be used with each new 24-hour ABPM procedure. Low battery power may prevent measurements from being taken over the full 24-hour period, and may cause errors in communication with the device.

CAUTION

When replacing the batteries, an internal battery preserves the internal real time clock for 10 minutes. After this time, the date and time information will be cleared and must be reset.

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