ABPM 6100 Operators Manual Rev B

Welch Allyn Ambulatory Blood Pressure Operator’s Manual

TABLE OF CONTENTS 1.

OVERVIEW ...2 1.1. 1.2.

2.

ABOUT THIS MANUAL ...2 SAFETY AND EFFECTIVENESS WARNINGS ...3

ABPM 6100 MONITOR ...5 2.1. INTRODUCTION ...5 2.1.1. Checklist ...6 2.1.2. About this Section...6 2.2. OPERATION ...6 2.2.1. At-a-Glance...7 2.2.2. Batteries...8 2.2.3. Controls ...8 2.2.4. The LCD Display...9 2.3. PROGRAMMING ...9 2.3.1. The Study... 10 2.3.2. Connecting the ABPM 6100 Monitor to the PC ... 10 2.3.3. Configuring the Serial Port... 10 2.3.4. Writing Parameters to the Unit ... 10 2.3.5. Self-Test ... 11 2.3.6. Date and Time ... 11 2.3.7. Options Defined... 11 2.4. INTERFACE ... 12 2.4.1. Preliminary Directive ... 12 2.4.2. Prior to Hook-up ... 12 2.4.3. Sizing ... 12 2.4.4. Cuff Placement ... 13 2.4.5. Office Readings ... 14 2.4.6. Regular Runs... 14 2.4.7. Disconnecting the ABPM 6100... 15 2.5. DATA ... 15 2.5.1. Reading Data from the Unit ... 15 2.6. MAINTENANCE AND CLEANING ... 16 2.6.1. Maintenance... 16 2.6.2. Cleaning... 16 2.6.3. Calibration Check ... 16 2.7. SPECIFICATIONS... 17 2.8. TROUBLESHOOTING AND ERROR CODES ... 18 2.8.1. Error Codes... 18 2.8.2. Troubleshooting... 19

3.

QUIETTRAK, ABPM... 20 3.1. INTRODUCTION ... 20 3.1.1. Checklist ... 21 3.1.2. About this Chapter... 22 3.2. OPERATION ... 22 3.2.1. At-a-Glance... 22 3.2.2. Batteries... 23 ii

Welch Allyn Ambulatory Blood Pressure Operator’s Manual

3.2.3. Controls ... 24 3.3. PROGRAMMING ... 24 3.3.1. Concepts ... 24 3.3.2. Self-Test ... 25 3.3.3. Date & Time... 25 3.3.4. Flowcharts ... 25 3.3.5. Options Defined... 30 3.3.6. Setting the Parameters... 31 3.4. INTERFACE ... 33 3.4.1. Preliminary Directive ... 33 3.4.2. Prior to Hook-up ... 33 3.4.3. Sizing ... 33 3.4.4. Placement... 34 3.4.5. Office Runs... 39 3.4.6. Regular Runs... 39 3.4.7. Disconnecting the QuietTrak, ABPM... 40 3.5. DATA ... 40 3.5.1. Report ... 40 3.5.2. Printing... 41 3.6. MAINTENANCE ... 42 3.6.1. Calibration... 42 3.6.2. Cleaning... 44 3.7. SPECIFICATIONS... 44 3.8. TROUBLESHOOTING AND ERROR MESSAGES ... 45 3.8.1. Error Messages ... 46 3.8.2. Special Messages... 47 3.8.3. Error Codes... 47 3.8.4. Troubleshooting Guide ... 48 4.

ABPM 6100 SOFTWARE ... 50 4.1. INTRODUCTION ... 50 4.1.1. File Overview... 50 4.1.2. ABPM 6100 Software Productivity Wizard... 50 4.1.3. The ABPM 6100 Software Window... 51 4.1.4. Getting Help with the ABPM 6100 Software ... 51 4.2. BEFORE THE STUDY - GETTING FAMILIAR WITH THE ABPM 6100 SOFTWARE 51 4.2.1. Creating a Practitioner File Cabinet... 51 4.2.2. The Patient Information View ... 52 4.2.3. The Study Specifics/Parameters View... 52 4.2.4. The Study Graph View ... 52 4.2.5. The Report... 52 4.2.6. The ABPM 6100 Software Toolbar Buttons ... 53 4.3. GETTING STARTED... 53 4.3.1. Setting Up Communications with the Unit ... 53 4.3.2. Programming the Unit for Patient Hookup... 53 4.3.3. Preparing the Unit... 54 4.3.4. Writing Parameters from an Existing Study... 54 4.3.5. Creating a New Patient Folder ... 54 4.3.6. Creating a New Patient Study ... 54 4.3.7. Reading Parameters from the Unit... 55 4.3.8. Erasing Data in the Unit... 55 4.3.9. Disconnecting the Unit ... 55 iii

Welch Allyn Ambulatory Blood Pressure Operator’s Manual

4.3.10. Closing a Practitioner File Cabinet ... 55 4.3.11. Closing the ABPM 6100 Software ... 55 4.4. AFTER THE STUDY ... 56 4.4.1. Unit Setup For Data Retrieval ... 56 4.4.2. Software Setup for Data Retrieval... 56 4.4.3. Reading Data from the Unit ... 56 4.4.4. Viewing Study BP Data... 56 4.4.5. Adding Comments to the BP Data ... 57 4.4.6. Rejecting and Accepting BP Data Readings ... 57 4.4.7. Viewing Accepted and Rejected BP Data... 57 4.4.8. Viewing Hourly Averages ... 57 4.4.9. Viewing Summary Statistics ... 58 4.4.10. Viewing Graphs... 58 4.4.11. The Accepted Data Graph... 59 4.4.12. The Hourly Averages Graph ... 59 4.5. REPORTS ... 60 4.5.1. The One Page Summary Report ... 60 4.5.2. Configuring a Custom Report ... 60 4.5.3. Configuring the Report Header... 61 4.5.4. Setting a Report as Default ... 61 4.5.5. Printing a Report... 61 4.6. EDITING INFORMATION IN THE ABPM 6100 SOFTWARE ... 62 4.6.1. Editing Patient Information ... 62 4.6.2. Editing Study Specific Patient Information ... 63 4.6.3. Editing Parameters... 63 4.6.4. Editing Display Periods/Limits ... 64 4.6.5. Editing the On Screen Graph Settings ... 65 4.6.6. Editing Speed Comments ... 65 4.7. CONFIGURING THE SOFTWARE... 66 4.7.1. Double Click to Edit ... 66 4.7.2. Configuring Colors... 66 4.7.3. Enabling the Productivity Wizard... 67 4.7.4. Right Click Menus ... 67 4.7.5. Importing Files... 67 4.7.6. Exporting Files... 68 4.7.7. Deleting Files... 68 4.8. SPECIFICATIONS... 68 4.8.1. System Requirements ... 68 5.

SERVICE AND WARRANTY ... 70 5.1. 5.2. 5.3.

WELCH ALLYN SERVICE CENTERS... 70 LICENSE AGREEMENT ... 71 WARRANTY INFORMATION ... 71

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Welch Allyn Ambulatory Blood Pressure Operator’s Manual

1.

Overview

The purpose of this chapter is to provide an overview of information that you will need to safely and effectively use the ABPM 6100 monitor, QuietTrak monitor, Tenso24, Welch Allyn ABPM, and the ABPM 6100 software. If you are using the ABPM 6100 Monitor, follow the instructions for the ABPM 6100 monitor. If you are using the QuietTrak, Welch Allyn ABPM, or Tenso24 monitor, follow the instructions for the QuietTrak, ABPM monitor. Information about the ABPM 6100 Software is available in the ABPM 6100 Software chapter of this manual. Make sure that you familiarize yourself with all of the safety precautions listed in this chapter before attempting to use either device or the software. In addition, this chapter features an About this Manual section explaining how to best utilize this manual to become familiar with each monitor, the software, and ambulatory blood pressure monitoring.

1.1. About this Manual This manual is designed to help you become familiar with the ABPM 6100 monitor, QuietTrak, ABPM unit, and the ABPM 6100 software. In addition to this manual, the ABPM 6100 software comes equipped with a comprehensive (English language only) online help system that contains information about every aspect of the ABPM 6100 software. The online help system may be accessed from the software at any point by pressing the F1 key, using the Help menu, or clicking any of the Help buttons throughout the software. The Welch Allyn Ambulatory Blood Pressure Monitoring Guide is designed to provide easy access to information about each monitor and the software. This Overview chapter provides information that is not specific to either monitor or the software. Chapters following the Overview chapter provide more detailed information about using a specific monitor or the ABPM 6100 software. You will not need to review a chapter that does not pertain to the monitor that you have. For example, if you are using only the ABPM 6100 monitor with the ABPM 6100 software, you will not need to read the QuietTrak, ABPM chapter. Here is a brief breakdown of the chapters in this manual: Chapter 1: Overview The Overview chapter (this chapter) provides general information intended to familiarize you with ambulatory blood pressure monitoring and with this manual. You should review Chapter 1 regardless of whether you will be using the ABPM 6100 monitor or the QuietTrak, ABPM. Chapter 2: ABPM 6100 Monitor The ABPM 6100 Monitor chapter provides information that is specific to the ABPM 6100 unit. This chapter explains how to program the unit using the ABPM 6100 software, perform a study using the unit, and read the study data back into the ABPM 6100 software. Since the ABPM 6100 unit works in close conjunction with the ABPM 6100 software, it is important to familiarize yourself with the material in Chapter 4 as well as Chapter 3 in order to use the ABPM 6100 monitor. Chapter 3: QuietTrak, ABPM The QuietTrak, ABPM chapter provides information that is specific to the QuietTrak, Welch Allyn ABPM, and Tenso24 units. Each of these units falls under the heading of QuietTrak, ABPM. This chapter explains how to program the unit, perform a study using the unit, and interpret the data after the study has been performed. If you plan to utilize the ABPM 6100 software to view, interpret, and report the data acquired using the QuietTrak, ABPM unit, you should also familiarize yourself with the material in Chapter 4. Note that if you are using a QuietTrak ABPM unit, the ABPM 6100 software is only compatible with your unit if your QuietTrak units has internal monitor software revision 4.2 or higher. Chapter 4: ABPM 6100 Software The ABPM 6100 Software chapter provides information that is specific to the ABPM 6100 software. The ABPM 6100 software may be used in conjunction with the ABPM 6100 unit and the QuietTrak, ABPM unit. When using the ABPM 6100 monitor, the ABPM 6100 software is necessary in order to write parameters to the unit before a study and view data after a study. Regardless of which monitor is being used, the ABPM 6100 software offers analysis and reporting tools to make the most of the ambulatory blood pressure monitoring process. 2

Welch Allyn Ambulatory Blood Pressure Operator’s Manual

Chapter 4 explains how to most effectively use the ABPM 6100 software. Chapter 5: Service and Warranty The Service and Warranty chapter provides useful reference information for the ABPM 6100 and QuietTrak, ABPM monitors and the ABPM 6100 software. Refer to this section if you are having any problems with either monitor or the software. The Service and Warranty section also contains a list of terms that you may reference, as well as an Accessories list.

1.2. Safety and Effectiveness Warnings Make sure that you are familiar with all Safety and Effectiveness considerations before using the ABPM 6100 monitor, QuietTrak, ABPM, or ABPM 6100 software.

PROPER USE OF THE ABPM 6100 AND QUIETTRAK, ABPM MONITORS: • • • •

The ABPM 6100 and QuietTrak, ABPM monitors are intended for use by a trained medical practitioner. Interpretation of blood pressure measurements should always be performed by a physician. The reliability of all the monitors and the software depend upon conformance with the operation and maintenance instructions in this manual. The ABPM 6100 and QuietTrak, ABPM monitors are designed for use with patients with normal sinus rhythms. Measurement accuracy for the ABPM 6100 and QuietTrak, ABPM monitors may be affected by position of the subject, physical conditions, movement, and use outside of the operating instructions contained in this manual.

IMPORTANT WARNINGS The following warnings apply to the ABPM 6100 and QuietTrak Ambulatory Blood Pressure Monitors. • DO NOT use the ABPM 6100 monitor or the QuietTrak, ABPM in the presence of flammable anesthetics due to risk of explosion. • DO NOT immerse the ABPM 6100 monitor or QuietTrak, ABPM in any fluid, place any fluid on the monitor, or attempt to clean either monitor with liquid detergents or cleaning agents. If any of these instances occurs, return the unit to an authorized Welch Allyn Service Center. The QuietTrak, ABPM may be wiped down with a damp cloth and mild soap. The ABPM 6100 may be cleaned with a damp cloth only. • DO NOT remove the ABPM 6100 or QuietTrak, ABPM covers. Neither unit contains any serviceable parts. • DO NOT use the monitor if it has failed any diagnostic self-test. • DO NOT use the unit if it displays a pressure greater than zero when no cuff is attached. This could lead to inaccurate measurements. • DO NOT attach the cuff to a limb being used for intravenous infusions. This may cause the infusion to be blocked and cause the patient harm. • DO NOT substitute any component for those supplied by Welch Allyn. • DO NOT attempt to repair the unit yourself. Repairs should be performed only by authorized Welch Allyn Service Centers • DO NOT attach the cuff to a patient while the PC Serial Connector is attached to the unit. • CAUTION: The ABPM 6100 and QuietTrak monitors are not intended for use on pregnant women or neonates. • CAUTION: The ABPM 6100, ABPM, and QuietTrak units may not yield accurate blood pressure measurements for patients experiencing moderate to severe arrhythmias. • CAUTION: Check to ensure that the operation of the unit does not result in prolonged impairment of the patient’s circulation. Instruct the patient to manually remove the cuff if it fails to deflate within three minutes. • CAUTION: Avoid compression or restriction of pressure tubes. 3

Welch Allyn Ambulatory Blood Pressure Operator’s Manual •

CAUTION: The QuietTrak, ABPM is not defibrillator protected; the ABPM 6100 is defibrillator protected. The ABPM 6100 has no specific precautions during defibrillation, and defibrillation has no effect on the ABPM 6100 monitor

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Welch Allyn Ambulatory Blood Pressure Operator’s Manual

2.

ABPM 6100 Monitor

2.1. Introduction Thank you for choosing the Welch Allyn ABPM 6100 Ambulatory Blood Pressure Monitor. This instrument comprises a synthesis of technological excellence with user-friendly design features. ABPM 6100 will add a whole new dimension to your clinical diagnostic capabilities by providing an effective means to monitor blood pressure in an outpatient context. Since the unit is small, lightweight, and inconspicuous, patients participate in around-the-clock monitoring with minimal disruption to normal daily cycles. Using the ABPM 6100 monitor to gather blood pressure data greatly reduces the margin of error in tests for pathological hypertension. ABPM 6100 helps reduce chances of unnecessary or inappropriate treatment, lowering overall costs for patients who genuinely qualify for hypertension therapy. The ABPM 6100 Unit is worn by the patient in a belt or shoulder strap and is connected to a cuff, which is wrapped around the non-dominant arm. ABPM 6100 inflates the cuff at pre-programmed intervals throughout the day and measures blood pressure using the oscillometric method, which senses the cessation of pressure waves in the artery when occluded by pressure in the cuff. Heart rate can also be measured using the frequency of pressure waves. Blood pressure measurements made by the ABPM 6100 are equivalent to those made by a trained observer using the cuff/stethoscope auscultation method within the limits prescribed by the American National Standard, Electronic or Automated Sphygmomanometers. To get the most out of the ABPM 6100, you should read this section of the manual thoroughly. You will also need to read and understand the ABPM 6100 Software section of this manual to properly interface the ABPM 6100 monitor with the ABPM 6100 software. To get started, you will need to read these sections first: § Operation § Programming § Interface To gain a sound working knowledge of your new ABPM 6100, use the Terms section in the Appendix of this manual.

!

If Luer lock connectors are used in the construction of the tubing, there is a possibility that they might be inadvertently connected to intravascular fluid systems. Care needs to be taken to avoid any connection to intravascular fluid systems, thus allowing air to be pumped into a blood vessel.

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Welch Allyn Ambulatory Blood Pressure Operator’s Manual

2.1.1. Checklist Check to make sure that the ABPM 6100 package contains the following:

ABPM 6100 Monitor

Adult Plus Size Cuff

PC Interface Cable

Belt and Shoulder Strap

Warranty Card

Patient Diary and Cuff Anchors

Not Pictured: • 4 AA Batteries • ABPM 6100 Software and Operator’s Manual CD • ABPM 6100 Quick Start Guide • Monitor Pouch

!

CAUTION: Substitution of a component different from that supplied might result in measurement error.

Remember to fill out your warranty registration card and send it to Welch Allyn as soon as possible. Report any damaged or missing components to your authorized Welch Allyn representative.

2.1.2. About this Section This section contains information specific to the ABPM 6100 monitor. Also read the Overview, ABPM 6100 Software, and Service and Warranty Information sections of this manual. The Service and Warranty Information contains accessory listings, service centers, and other helpful information.

2.2. Operation This section provides a brief overview of the ABPM 6100 unit, how to load the batteries, and the unit controls.

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Welch Allyn Ambulatory Blood Pressure Operator’s Manual

2.2.1. At-a-Glance

The ABPM 6100 features a simple design. One Start/Stop button functions as the primary control. The LCD (liquid crystal display) displays easy-to-read information. The ABPM 6100 software allows you to program the unit before the study and retrieve data after the study. A single air hose connector allows you to connect the cuff to the unit.

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Welch Allyn Ambulatory Blood Pressure Operator’s Manual

On the back of the ABPM 6100 monitor, a label lists the model and serial number of the unit. The first four digits of the serial number correspond to the year that the unit was manufactured. The battery compartment is on the back of the unit.

The connector on the bottom of the unit allows you to connect the unit to a PC using the PC Interface Cable.

2.2.2. Batteries The ABPM 6100 monitor requires 2 AA batteries. Batteries are installed into the ABPM 6100 unit in the battery bay located at the back of the unit. If rechargeable batteries are used, please refer to the manufacturer’s guidelines for safe use and adequate maintenance. When batteries are properly loaded and first installed, the unit will display the following: • Incrementing dashes for 2 seconds. • Two sets of numbers, the first set of three being the Software Version • Battery voltage displayed for 2 seconds (prior to the voltage, the letter “b” will present) • Three quick audible beeps. • The number of BP readings (if any) in memory along with a flashing printer symbol for 3 seconds (the number of readings may not be displayed if the batteries were removed before the unit was turned off) • One long audible beep. • Displays flashing time for 20 seconds (after 20 seconds the units turns itself off and goes into Sleep Mode to conserve battery life) At this point the unit will be ready to upload a BP Study. When the unit is turned on subsequently, the unit will display the following: • Three quick audible beeps. • The number of BP readings (if any) in memory along with a flashing printer symbol for 3 seconds. • One long audible beep. • Displays flashing time for 20 seconds (after 20 seconds the units turns itself off and goes into Sleep Mode to conserve battery life)

2.2.3. Controls

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Welch Allyn Ambulatory Blood Pressure Operator’s Manual

Start/Stop Button LCD

The Start/Stop button allows you to perform the following functions: • Turn the unit On when it is Off. • Put the unit into Study Mode and take a reading when the unit is in Normal Mode. The time will flash on the LCD when the unit is in Normal Mode. • Turn the unit Off from Normal or Study mode when the button is pressed and held until the unit beeps five times (approximately five seconds) • Initiate a reading when the unit is in Study Mode. • Abort a reading and deflate the cuff if pressed when the unit is taking a reading.

2.2.4. The LCD Display The LCD displays the following information depending upon the state that the unit is in: • The time is displayed whenever the unit is in Normal Mode and ready for an action. • A sun symbol is displayed whenever the unit is in Study Mode. • A clock is displayed whenever the unit is in Study Mode. • A battery symbol is displayed whenever the battery voltage is low and the batteries need to be replaced.

! •

Care needs to be taken to avoid removing the batteries from the unit for any length greater than 15 minutes. Even though the battery level may be too low to actuate the pumps, there will be enough charge to maintain the internal clock and patient readings for many months.

A printer symbol indicates that the unit contains readings in the memory.

2.3. Programming The ABPM 6100 monitor utilizes and requires the ABPM 6100 software to configure the parameters for a Study. The study parameters are uploaded to the ABPM 6100 monitor using the PC Interface Cable. This section explains how to upload a study to the unit. Before uploading the Study, you must create a Study in the ABPM 6100 software. See the ABPM 6100 Software section of this manual for instructions on creating a Study.

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Welch Allyn Ambulatory Blood Pressure Operator’s Manual

2.3.1. The Study The ABPM 6100 software allows you to prepare a study and upload that Study to the ABPM 6100 monitor. The Study contains parameters and data that comprise the BP measurement plan that the ABPM 6100 monitor will use. See the ABPM 6100 Software chapter of this manual for instruction on creating a Study.

2.3.2. Connecting the ABPM 6100 Monitor to the PC Before you will be able to upload the Study to the ABPM 6100 monitor, you will need to connect the monitor to the PC. This is done using the PC Interface Cable that came with your ABPM 6100 monitor. One end of the cable contains a small plug that inserts into the jack at the bottom of the unit. The other end of the cable contains a larger (nine-pin) adaptor that plugs into the serial communications port on the back of your PC. To connect the cable to the PC, simply insert the nine-pin adaptor into the serial port and fully tighten the screws to secure the connection. The cable may remain attached to the PC even when the unit is not connected. Next, plug the smaller (stereo jack) end of the cable into the port at the bottom of the unit.

2.3.3. Configuring the Serial Port Once you have attached the ABPM 6100 monitor to the PC using the PC Interface Cable, you will need to configure the serial port using the ABPM 6100 software. To do this, open the ABPM 6100 software and select Options from the Tools menu, and click the number of the serial port that you have plugged the PC Interface Cable into. If you do not know the number of the serial port, click a serial port to select it and click the Test button. If the unit is connected properly to the serial port that you have connected, the software will read and display the serial number of the unit connected. If the ABPM 6100 software is unable to read the serial number, click another serial port to select it and click the Test button again. Once you have selected the appropriate serial port, click the OK button to close the Options dialog box.

2.3.4. Writing Parameters to the Unit Once the Study that you wish to use has been created using the ABPM 6100 software, you may write the Study parameters to the ABPM 6100 monitor. Before writing the Study parameters to the unit, make sure that the following three items are true: • • •

The ABPM 6100 monitor contains fresh batteries. The ABPM 6100 Software displays the Study that you wish to upload to the unit. The PC Interface Cable connects the ABPM 6100 unit to the PC.

Note: If the ABPM 6100 Software contains an existing Study with BP Data from which you wish to use the parameters, you may do so by selecting the existing study. With the above criteria satisfied, use the following instructions to upload the Study parameters to the ABPM 6100 monitor: 1. 2. 3.

Check to make sure that the Study you wish to use parameters from is selected in the ABPM 6100 software. From the View menu, select Study Specifics/Parameters and examine the parameters to make sure they are the parameters that you wish to write to the unit. If you are sure that you wish to write the parameters to the unit, select Write Parameters to the Unit from the Communicate menu. Note: If the ABPM 6100 unit contains data when you attempt to write parameters to it, the ABPM 6100 software will display a message alerting you that there is data in the unit. If you wish to erase the Data in the unit, click Yes. If the data in the unit has not yet been read into an ABPM 6100 Software study, read the data into a study before erasing it.

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Welch Allyn Ambulatory Blood Pressure Operator’s Manual

4.

If the parameters are successfully written to the ABPM 6100 unit, the unit LCD will enter Sleep Mode to conserve battery power until you are ready to begin the study. You may “wake” the unit at any time by pressing the Start/Stop button once.

2.3.5. Self-Test The ABPM 6100 monitor performs a number of self-tests at power up and during normal operation. If the unit fails any of these diagnostic self-tests, an error message will be displayed on the LCD screen. These self-tests occur “behind the scenes” and will not display any message unless an error is detected. See the Troubleshooting and Error Codes section of this chapter for an explanation of any Error Codes that you receive.

2.3.6. Date and Time The Date and Time used by the monitor will be read from the internal clock in your PC. The internal date and time will be updated to match the internal PC clock whenever parameters are written from the ABPM 6100 software to the ABPM 6100 unit.

2.3.7. Options Defined The ABPM 6100 software allows you to configure a variety of parameters that will be written to the ABPM 6100 unit. This section defines the unit parameters that you can use the ABPM 6100 software to define.

• • •

•

Maximum Inflation Pressure: Allows you to select the maximum pressure that the unit will inflate the cuff to. Pressures may be selected from 160 to 270 mmHg at 10 mmHg intervals. Deflation Rate: Allows you to select Normal (10 mmHg per second) or Slow cuff deflation (5 mmHg per second) for the study. Start Button On: Allows you to enable and disable the ABPM 6100 monitor’s Start button. If the Start button is disabled for a study, manual readings will still be able to be initiated using the Start button for 30 minutes after the parameters have been written to the unit and the unit is woken from Sleep Mode. The Start Button will also be available to manually cancel a reading regardless of how this parameter is configured. Display On: Allows you to enable or disable the LCD display for the Study. 11

Welch Allyn Ambulatory Blood Pressure Operator’s Manual

• • •

Note: Viewing readings in progress may affect the patient’s blood pressure. Time Periods: Allows you to configure the number of time periods for the Study by choosing 1, 2, 3, or 4. Start and End Times and Intervals will appear for each Time Period. Start Time: Allows you to select the Start Time for the selected period. If a period exists before the selected period, the Start Time will determine the end of the previous period. Minute Interval: Allows you to select the interval in minutes between blood pressure readings. You may select 5, 10, 15, 20, 30, 60, 120, or MAN (for manually initiated readings only). Note that for time intervals of 10 minutes or greater, that the system is designed to add up to +/- 5-minute variance at each interval. This is to eliminate potential variations resulting from the patient anticipating the exact time of the next reading.

Selecting each of the above parameters and writing them to the unit will provide the ABPM 6100 monitor with all of the parameters necessary for the study.

2.4. Interface This section describes how to connect the ABPM 6100 monitor to the patient for monitoring sessions.

2.4.1. Preliminary Directive Advise the patient to: • Wear a loose fitting blouse or shirt. • Avoid wearing long sleeved sweaters or dresses during monitoring period. • Avoid swimming, showering, or bathing during monitoring. • Avoid operating heavy equipment or power tools, as vibrations may functionally disrupt the monitor.

2.4.2. Prior to Hook-up Before hooking the ABPM 6100 unit up to the patient, make sure you have performed the following tasks: • • • • •

Be sure the patient name and ID are on the diary and logged separately to avoid confusion with other patient data. Make sure that the ABPM 6100 monitor contains new or charged batteries. For new studies, make sure that all old data has been downloaded to the ABPM 6100 software and the ABPM 6100 monitor’s memory has been cleared out. Make sure that the proper Study parameters have been written from the ABPM 6100 software to the unit. Seat the patient comfortably. If the patient has long sleeves, have the patient remove his or her shirt. Ask the patient which is the non-dominant arm. You will place the cuff on this arm.

2.4.3. Sizing Since correct cuff sizing is vital to the accuracy of monitoring data, make sure that you read this section carefully and understand all of the information contained herein before sizing the cuff to the patient.

USING THE CUFF RANGE MARKS Each cuff has two range marks. To size using the range marks, wrap the cuff around the patient’s non-dominant arm. If the edge of the cuff falls within the range marks, the cuff is the correct size for the patient. If the cuff edge does not fall within the range marks, try a different size cuff.

USING THE SIZING TABLE To use the sizing table, find the circumference of the patient’s upper arm and refer to this cuff sizing chart. Cuff Size Pediatric Cuff Small Adult Cuff

Arm Circumference 16.0 – 21.8 cm (6.3” – 8.6”) 21.1 – 26.6 cm (8.3” – 10.5”) 12

Welch Allyn Ambulatory Blood Pressure Operator’s Manual

Adult Cuff Adult Plus Cuff Large Adult Cuff

25.4 – 34.3 cm (10.0” – 13.5”) 27.0 – 42.0 cm (10.6” – 16.5”) 34.3 – 48.2 cm (13.5” – 19.0”)

2.4.4. Cuff Placement Proper cuff placement is very important to achieve accurate blood pressure measurements. Follow these instructions to ensure the cuff is accurately placed on the patient. 1.

Wrap the cuff snugly around the patient’s non-dominant arm as shown below, making sure that the air hose leading from the cuff is not crimped or damaged. The cuff may be worn over a thin shirt without compromising the readings.

2.

Attach an adhesive cuff anchor to the clear tab on the cuff, and fasten the cuff anchor to the patient.

Note: Make sure that the parameters have been written to the ABPM 6100 monitor before proceeding. The monitor should be in sleep mode. 3.

Attach the tubing from the ABPM 6100 monitor to the cuff tubing and insert the ABPM 6100 monitor into the monitor pouch. Attach the pouch to the shoulder strap or the belt, depending upon which is more comfortable to the patient. Be sure to allow enough slack for the patient to move comfortably. 13

Welch Allyn Ambulatory Blood Pressure Operator’s Manual

2.4.5. Office Readings Once the ABPM 6100 monitor has been properly attached to the patient and the PC interface cable has been removed from the unit, it is important and necessary to perform office readings in order to make sure that the unit is functioning properly and does not cause discomfort to the patient. The ABPM 6100 monitor will not begin regular runs until at least one manually initiated reading has been taken. Follow these instructions to perform an Office Reading: 1. If the unit is in Sleep Mode (no display on the LCD), press the Start/Stop button to “wake” the unit. 2. Press the Start/Stop button again to initiate a manual reading. This will cause the cuff to inflate and a reading to be taken. 3. Record the readings that are taken in the office as office readings into the patient diary, so that information can be taken into account in the analysis of the study. This is also a good opportunity to instruct the patient about the use of the patient diary. If the Start button is disabled when the parameters are written to the unit (thus disallowing initiation of manual readings), the ABPM 6100 monitor still allows you to manually initiate measurement for up to 30 minutes after parameters have been written to the unit and the unit has been “woken” from Sleep Mode. This allows you to initiate manual office readings even if you do not wish the patient to be able to initiate readings.

2.4.6. Regular Runs Once at least one manual office reading has been taken, regular readings will initiate based upon the interval configured for the first time period.

BEFORE THE PATIENT LEAVES Make sure of the following before the patient leaves the office: • The belt or shoulder strap and pouch are positioned comfortably. • The Start/Stop button is accessible to the patient. (Even if the Start button is disabled in the Study Parameters, the Start/Stop button will still allow the patient to cancel a reading.) • The ABPM 6100 monitor is concealed according to the patient’s wishes. • Remember the patient’s comfort and ability to perform normal tasks can significantly impact the relevance of monitoring data. • If the display is on, briefly review with the patient how to read the data. • Explain to the patient the kind of information required in the Patient Diary. • If the Start button is enabled, explain to the patient that he or she has the option to initiate readings using the Start/Stop button.

OTHER INSTRUCTIONS FOR PATIENTS The patient should also be advised of the following: • Pressing the Start/Stop button during a reading will cancel that reading and deflate the cuff regardless of whether the Start button is set to On or Off in the Study Parameters. • Advise the patient to undress carefully at bedtime, using caution not to disconnect the hose from the monitor. • Placing a pillow over the monitor during sleep will reduce any electrostatic hum from the ABPM 6100 unit. • All data is stored internally after deactivation.

PATIENT DO’S AND DON’TS: Finally, familiarize the patient with the following list of do’s and don’ts: Do: • Record time, symptom/mood and activity/position in the patient diary. • Activate a reading (if the Start/Stop button is activated) at the first sign of symptoms. • Remain motionless during readings. 14

Welch Allyn Ambulatory Blood Pressure Operator’s Manual • • Don’t: • • • •

Keep vehicle driving & travel to a minimum. Bring diary upon return. Remove the cuff. Get the monitor wet. Use power tools or heavy equipment during a reading. Remove the batteries from the unit

2.4.7. Disconnecting the ABPM 6100 When the patient returns, you may assist them in disconnecting the monitor by following these instructions: 1. Assist the patient with disconnecting the cuff. 2. Remove belt, strap, and pouch and set aside for cleaning later. 3. Review the patient’s diary. Clarify any information that is unclear or possibly in error. Ask about possible omissions. 4. Instruct the patient that they are free to go. 5. Press and hold the Start/Stop button to turn the unit off (the unit will beep five times before turning off). This will conserve the battery power until you are ready to read the data from the ABPM 6100 monitor into the ABPM 6100 software.

2.5. Data After the ABPM 6100 monitor is disconnected from the patient, you will need to reconnect the monitor to the PC in order to read data from the unit. To reattach the monitor to the PC, simply locate the monitor (smaller) end of the PC Interface Cable and insert it into the communications port located at the bottom of the unit (the PC end of the PC Interface Cable should still be attached to the PC). See the Connecting the ABPM 6100 to the PC section of this chapter for more information.

2.5.1. Reading Data from the Unit Whenever data is contained in the unit, it can be read from the unit into the ABPM 6100 software. The ABPM 6100 software will then allow you to view the data and configure reports. See the ABPM 6100 Software chapter for more information. To read data from the unit: 1. 2. 3.

4. 5.

Make sure that the ABPM 6100 monitor is properly connected to the PC. Open the ABPM 6100 software. Select the Patient Study that you wish to read data into by clicking the representative date under the appropriate patient name. If no Patient Study has been created yet, create a Patient Study by following the instructions in the Creating a New Patient Study section of the ABPM 6100 Software chapter. From the Communicate menu, select Read Data from Unit. (Make sure that you select Read Data from Unit rather than Read Parameters from Unit.) Within a few seconds, the data will be retrieved from the unit. If the Patient ID in the Unit does not match the Patient ID in the ABPM 6100 Software Patient Study, a message will appear stating, “Patient ID in unit and study do not agree. Use ID in unit?” Select Yes to use the Patient ID currently stored in the unit; select No to use the Patient ID in the ABPM 6100 software.

The data from the unit will now be stored in the ABPM 6100 software. If you receive an error message when you try to read data from the unit, make sure the PC Interface Cable is properly attached to both the monitor and the PC and repeat the Read Data from Unit command. See the ABPM 6100 Software chapter of this manual for instructions on using the software and the data handling and reporting options it offers.

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Welch Allyn Ambulatory Blood Pressure Operator’s Manual

2.6. Maintenance and Cleaning Preventative maintenance should be routinely performed to ensure the safe and efficient operation of the ABPM 6100 monitor. In addition, the monitor should be cleaned after each use.

2.6.1. Maintenance The following inspections of the ABPM 6100 unit should be performed on a regular basis: • • • •

The PC connection cable should be inspected for any cracks, exposed wires or other damage. The monitor itself should be visibly inspected for any signs of damage. Pneumatic tubing should be inspected for any cracks, fraying, or kinks. Do not remove any covers or break the warranty seal while inspecting the unit.

If any signs of damage are detected, do not use the ABPM 6100 monitor. It should be sent to an authorized Welch Allyn service center. See the Service and Warranty section of this manual for a list of authorized Welch Allyn service centers.

2.6.2. Cleaning CLEANING THE ABPM 6100 UNIT The ABPM 6100 unit should be cleaned after every use. Use a soft, damp cloth to remove any dirt and dust from the unit. IMPORTANT: The ABPM 6100 cannot be sterilized. DO NOT immerse the monitor in any fluid or use liquid detergents, cleaning agents, or solvents to clean it. If the unit is immersed in any liquid, do not use the unit again. The unit should be sent to an authorized Welch Allyn service center.

DISINFECTING THE CUFF A mild disinfectant solution should be used on the cuff. Do not remove the nylon bladder inside of the cuff during this process.

2.6.3. Calibration Check Welch Allyn recommends that the calibration of the ABPM 6100 monitor be verified annually using the following procedure: 1.

2.

3. 4.

5.

6.

With the ABPM 6100 unit already powered up, remove one of the AA batteries from the battery compartment. Then immediately replace the battery back in its proper orientation, which will result in the unit to start the power up cycle. While the LCD is displaying dashes, press and hold down the Start/Stop button. The unit will display the software version, the battery voltage, followed by a click as the valves are closed. When the process is finished, a pressure value will be displayed on the LCD and the unit is ready to have the calibration checked. Disconnect the ABPM 6100 monitor cuff assembly from the unit Attach the appropriate end of ABPM 6100 Y-connector (Welch Allyn Part #6100-25) to the monitor. Attach a cuff to the appropriate end of the Y-connector, and wrap around a suitably sized can or bottle. This acts as the reservoir for the unit. Connect the third leg of the Y-connector to a high quality, known pressure standard1. Refer to the calibration figure in the Calibration section of the QuietTrak, ABPM chapter for a sketch of the test set up. Pressurize gauge to 250 mmHg and compare against pressure standard (see Note below). If the unit does not meet the required calibration, unit needs to be returned to Welch Allyn for calibration or repair. Bleed pressure down no faster than 10 mmHg per second, stopping to check the pressure at 250, 200, 150, 100, and 50 mmHg 16

Welch Allyn Ambulatory Blood Pressure Operator’s Manual

7.

When finished, remove one of the AA batteries from the battery compartment. Then immediately replace the battery back in its proper orientation, which will cause the unit to start the power up cycle.

Note: Your ability to measure the accuracy of the ABPM 6100 depends upon the sensitivity of the pressure standard you use for the calibration procedure. • •

If using a manometer (mercury column or aneroid gauge) rated at ± 3.0 mm Hg, you will be able to determine the accuracy of the unit being tested to within ± 6.0 mm Hg. If using a device (e.g., digital pressure standard) rated at ± 1.0 mm Hg, you will be able to determine the accuracy of the unit being tested to within ± 4.0 mm Hg.

1

Welch Allyn recommends using the most sensitive pressure standard possible when performing calibration checks. A Setra Pressure Meter 2270-01, which is calibrated for ± 0.1 mm Hg, works well for this application.

2.7. Specifications This section provides the unit specifications for the ABPM 6100 ambulatory blood pressure monitor. Power Requirements: • Two “AA” alkaline batteries or high capacity rechargeable batteries (NiMH). Dimensions: • 124 x 70 x 33 mm (approximate). Weight: • 270g (including batteries, approximate). Operating Ambients: 17