Mortara Ambulo 2400 User Manual
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Mortara Ambulo 2400 User Manual

Ambulatory blood pressure monitor
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REF 9515-182-50-ENG Rev K1
Manufactured by Mortara Instrument, Inc., Milwaukee, Wisconsin U.S.A.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Ambulo 2400
AMBULATORY BLOOD PRESSURE MONITOR
USER MANUAL

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Summary of Contents for Mortara Ambulo 2400

  • Page 1 REF 9515-182-50-ENG Rev K1 Ambulo 2400 AMBULATORY BLOOD PRESSURE MONITOR USER MANUAL Manufactured by Mortara Instrument, Inc., Milwaukee, Wisconsin U.S.A. CAUTION: Federal law restricts this device to sale by or on the order of a physician.
  • Page 2 7865 N. 86th Street Milwaukee, Wisconsin 53224 This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc. Ambulo, and EasyWear are trademarks of Mortara Instrument, Inc.
  • Page 3 TECHNICAL SUPPORT AND SERVICE Headquarters Sales Support/ Supplies & Accessories Mortara Instrument, Inc. 7865 North 86th Street Mortara Instrument, Inc. Milwaukee, WI 53224 7865 North 86th Street U.S.A. Milwaukee, WI 53224 Tel: 414.354.1600 U.S.A. Tel: 800.231.7437 Tel: 414.354.1600 Fax: 414.354.4760 Fax: 414.354.4760...
  • Page 4 Failure to do so may cause undue failure and possible health hazards. Equipment Identification Mortara Instrument, Inc. equipment is identified by a serial and reference number on the back of the device. Care should be taken so that these numbers are not defaced.

  • Page 5: Warranty Information

    Product/s returned to Mortara’s principal place or any other place as specifically designated by Mortara or an authorized distributor or representative of Mortara, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Mortara is limited and that Mortara does not function as an insurer. A purchaser of a Product/s, by its acceptance and purchase thereof, acknowledges and agrees that Mortara is not liable for loss, harm, or damage due directly or indirectly to an occurrence or consequence there from relating to the Product/s.
  • Page 6 PRODUCT/S FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT/S TO THE EXTENT THAT THE DEFECT IS NOTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL MORTARA BE LIABLE FOR INCIDENTAL, SPECIAL, OR...
  • Page 7 Inflation Pressure” above 300mmHg is entered the system will automatically enter the value of 300mmHg. Further, if a “Top Inflation Pressure” above 285mmHg is entered and sent to an AMBULO 2400 device the HDS software returned an error message. If the AMBULO 2400 device is then disconnected from the system running the HDS software, the device displays an error “SE 18”...
  • Page 8 • NIBP cuffs and hoses supplied with the Ambulo 2400 do NOT contain any Latex. If the patient develops an allergic reaction or rashes, immediately remove the cuff. •...
  • Page 9 USER SAFETY INFORMATION • Do not operate the device in conjunction with or in close proximity to other devices such as high frequency surgical instruments, defibrillators, imaging systems, or other diagnostic or therapeutic devices. Simultaneous operation may damage the device or lead to erroneous results. •...
  • Page 10 EQUIPMENT SYMBOLS AND MARKINGS Symbol Delineation Attention, consult accompanying documents. Indicates device has been tested for safety from vertically dripping water; specifically, it indicates DRIP PROOF, a higher than ordinary level of IPX1 protection from drips, leaks, and spills. Defibrillator-proof type BF applied part. Tested for safety by the Canadian Standards Association according to applicable U.S.
  • Page 11 Check the device for any visible damage. • Inspect cuffs, bladders, and tubes for any visible damage. If you notice anything that requires repair, do not use the equipment. Contact Mortara Technical Service for any necessary repairs. Cleaning the Cuffs Orbit Cuffs Orbit cuffs may be cleaned with a mild disinfectant spray.
  • Page 12 GENERAL CARE Do not use excessive drying techniques such as forced heat. Refer to additional Instructions for Use provided with the cuffs. After removal for washing, the bladders can be rolled and carefully placed back in place. Ensure that the bladder is properly put back in place and is flat without kinks.
  • Page 13 Operation of the equipment beyond its specified ranges, or beyond normal physiological conditions of human subjects, may cause inaccurate results. The use of accessories, transducers, and cables other than those specified by Mortara Instrument may result in increased emissions or decreased immunity of the equipment.
  • Page 14 ELECTROMAGNETIC COMPATIBILITY (EMC) Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment. Emissions Test Compliance Compliance Level...
  • Page 15 ELECTROMAGNETIC COMPATIBILITY (EMC) Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or the user of the equipment should ensure that it is used in such an environment. IEC 60601 Test Compliance Emissions Test...
  • Page 16 ELECTROMAGNETIC COMPATIBILITY (EMC) Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Equipment The equipment is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the equipment can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the equipment as recommended in the table below, according to the maximum output power of the communications equipment.

  • Page 17: Table Of Contents

    TABLE OF CONTENTS INTRODUCTION SECTION 1 Manual Purpose ................................1 Audience ..................................1 Intended Use .................................. 1 Indications for Use................................. 1 Contraindications ................................1 Clinical Validation ................................. 2 Pediatric Features ................................2 System Description ................................ 2 Figure 1-1, Device Overview ............................3 Specifications ................................
  • Page 18 ELECTROMAGNETIC COMPATIBILITY (EMC) PERFORMING AN ABPM PROCEDURE SECTION 6 Performing an ABPM Procedure ..........................36 Downloading and Reviewing Data Measurements ...................... 40 TROUBLESHOOTING AND MAINTENANCE APPENDIX A Troubleshooting ................................41 Maintenance ................................42 Check Calibration of the ABPM Device ........................42 ERROR AND DIAGNOSTIC CODES APPENDIX B Error and Diagnostic Codes ............................

  • Page 19: Introduction Section

    Indications for Use The Ambulo 2400 Ambulatory Blood Pressure Monitor is indicated for use in adult & pediatric patient populations; it is not indicated for use with neonates. The Ambulo 2400 Ambulatory Blood Pressure Monitor is designed to measure systolic and diastolic blood pressure and pulse rate of adults and pediatric patients, using the oscillometric method on a cuffed arm.

  • Page 20: Clinical Validation

    K5 Korotkoff sounds on 55 subjects and the K4 Korotkoff sound on 30 subjects. The results of the study indicate that the Ambulo 2400 meets the highest standards of both the global ISO 81060-2 as well as the stringent requirements of the British Hypertension Society’s protocols ensuring that the system performs equally well in all blood pressure ranges.

  • Page 21: Device Overview

    SECTION 1 Device Overview Figure 1-1 A. Air socket B. LCD panel C. Start/Stop button D. USB interface E. Battery door...

  • Page 22: Software Operation Section

    SECTION 1 LCD Panel During initial power-up, all available segments of the LCD will be turned on to verify correct functionality of the display. Not all available segments on the LCD are relevant to this device at any given time, and they may be activated during different operations.

  • Page 23: Viewing Data Measurements Section

    In order to reset the Ambulo 2400 to go through its full-scale baseline measurement mode–from initial top pressure set all the way down to 45 mmHg (50 mmHg in firmware versions 1.48 and beyond)–press and release the button three consecutive times.

  • Page 24: Specifications

    SECTION 1 Specifications FEATURE SPECIFICATION Dimensions 4.7 x 2.7 x 1.2" (119 x 68 x 32 mm) Weight 9.0 oz (253 g) (with batteries) Measurement Principle Patented oscillometric technique with linear deflation. Systolic: 60 to 280 mmHg Measurement Ranges Diastolic: 40 to 160 mmHg Pulse Rate: 30 to 180 bpm...

  • Page 25: Accessories

    Description 6901-023-01 CUFF BP AMBULO SMALL ADULT 18–27 CM 6901-023-02 CUFF BP AMBULO ADULT 25–35 CM 6901-023-03 CUFF AMBULO ADULT PLUS 33–40 CM 6901-023-04 CUFF AMBULO LARGE ADULT 39–46 CM Contact your dealer or go to www.mortara.com for more information.
  • Page 26 SECTION 1...

  • Page 27: Equipment Preparation Section

    EQUIPMENT PREPARATION SECTION 2 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 EasyWear cuff, use the extension hose to connect the air socket and the blood pressure cuff.

  • Page 28: Usb Interface

    -based personal computer. To do this, connect the ABPM to the PC using the provided USB cable. The Ambulo 2400 system has been successfully tested with both USB 2.0 and USB 1.1-based systems. CAUTION: Do not attach the ABPM device to a patient when it is connected to a PC via the USB cable.

  • Page 29: Software Installation Section

    SOFTWARE INSTALLATION SECTION 3 Software Requirements The computer must meet the minimum hardware requirements to successfully install the ABPM software: Operating System Windows 7 (any version) Windows 8.1 64-bit NOTE: Requirement for signed USB drivers must be turned off for Windows 8.1 Memory (RAM) 256 MB Disk Space...

  • Page 30: Installing Usb Drivers

    This warning may be disregarded. If this warning appears, select “Install this driver software anyway”. NOTE: The Ambulo 2400 USB driver is unsigned. To successfully install the Ambulo 2400 USB driver on certain Windows operating systems such as Windows 8.1, it is necessary to temporarily disable the driver signature enforcement of Windows prior to successful installation.

  • Page 31: Starting The Program

    Use the Download Data from Device icon to automatically extract measurements from the Ambulo 2400 (device must be connected to the PC via the USB cable), and add the information to a patient’s records. Use the Import/Export icon to export/import patients and studies to/from external files.

  • Page 32: Software Configuration Menu

    SECTION 4 Software Configuration Menu With Software Configuration, users can control display options within the software. To access the Software Configuration menu, click the Software Configuration icon, or select the option from the Tools menu at any time. • Device Management COM Port Setting •...

  • Page 33: Browse Patients

    SECTION 4 Optional fields can be printed on the report if data is entered: • Middle Name • Primary Physician • Interpreting Physician • Notes – Any relevant notes on the patient or the procedure, including the physician’s interpretation of the results, may be entered here before, during, or after the procedure.

  • Page 34: Configuring Device

    SECTION 4 To delete a patient and all corresponding measurements, select the desired patient and then select Delete from the Edit drop-down menu. To delete an entire folder, right click the desired folder and select Delete Folder; to delete all the patients within a folder but not the folder itself, select Delete All Patients.
  • Page 35 SECTION 4 • Start Time – Dictates when the measurement period will begin, and is limited by the start time of the following period. Note that the start times for the four periods must be consecutive. • Frequency – Pertains to how often a measurement is taken within the set period times. •...
  • Page 36 SECTION 4 Sequential Plans The Sequential Plans tab further expands the dialog to include a listing of measurements and periods. This screen provides options for configuring measurements to occur at specified intervals following an initiating trigger rather than occurring at predetermined times of day. Initial top pressure is a single study-wide setting which applies to all measurements.
  • Page 37 SECTION 4 • Result Duration – Controls the number of seconds for which the results are displayed. Choose a value from the drop-down menu or type the desired value in the space available. If Result is not part of the Display setting, results are not displayed and the value for Result Duration has no effect.
  • Page 38 SECTION 4 Sequence Plan Example A sample sequence plan is installed with the software. It is located in the application’s installation directory and is named SequenceSample.xml. This sequence plan may be loaded into the Device Configuration window by using Load Plan. The right hand side of the screen displays a sample sequence plan where the initial period is configured to enable the buzzer and all button...

  • Page 39: Getting Data Measurements

    SECTION 4 Getting Data Measurements To download measurement data from the device, it must be connected to a PC (via USB cable) hosting the ABPM software and the software must be running. Click the Download Data from the Device icon on the Main menu or use Download Data from the Patient View toolbar.

  • Page 40: Additional Operations

    Mortara Technical Support for assistance. WARNING: Ensusre AMBULO 2400 has fresh AA batteries before running the diagnostics program. NOTE: Do not connect the ABPM device to USB without batteries installed. While the ABPM device may turn on solely on USB-supplied power, it will not operate reliably in this manner and needs batteries to properly function including during device configuration, data download or testing.
  • Page 41 The location searched on the computer can be configured in system properties located in the software configuration window. NOTE: This function is mainly used in combination with the Mortara Web Upload 3.0 product. See Web Upload 3.0 User Manual for more details.
  • Page 42 SECTION 4 New/Open Database At any point, it is possible to create an entirely new database or open a previously created database for storing patient information. This may be done for several reasons, including: • Keeping information for different physicians or clinics, or information from one year to another, separate from each other.
  • Page 43 This information might be necessary if you ever need to obtain technical support from your Mortara Technical Support representative. Use the available link to access an electronic version of the End User License Agreement.
  • Page 44 SECTION 4...
  • Page 45 If a single measurement appears to be invalid or erroneous, it can be excluded so that it does not skew the overall results. While the Ambulo 2400 has built-in capabilities to detect and reject certain motion artifacts, it is possible to get outlier measurements –...
  • Page 46 SECTION 5 In addition to hourly increments, the Awake/Asleep times can be changed to more specific figures. To edit the minutes, highlight them with the cursor and manually enter the values. Switching to another view (i.e., Table View) will automatically save and apply these values to the measurement data. Range Limits Range limits are numbers that can target specific sets of data by changing the color of the numbers presented on the table.

  • Page 47: Graphical View

    SECTION 5 Graphical View Graphical View is used to view selected data measurement ranges as plotted within an X & Y-axis diagram. Prior to selecting Graphical View on the menu toolbar, a patient name must be selected in the Patient View. If there are multiple studies for a patient, ensure that the appropriate study is selected.

  • Page 48: Actigraphy View

    The device will collect actigraphy data along with blood pressure readings. NOTE: Not all models of the Ambulo 2400 include the actigraphy option. If actigraphy data exists along with the patient’s measurements, it can be viewed by clicking Actigraphy View in the menu toolbar.

  • Page 49: Histogram View

    SECTION 5 Histogram View Use the Histogram tab to view the selected data range in a bar graph. This graph represents the distribution of the systolic, diastolic and pulse measurements as a percentage of the total measurements, and is divided into four distinct data sets: Systolic (Awake), Systolic (Asleep), Diastolic (Awake), and Diastolic (Asleep).

  • Page 50: Comparison View

    SECTION 5 The percentages of measurements exceeding certain limits—referred to as “blood pressure load” in clinical terminology—are provided for Overall, Awake, and Asleep measurements (these limits may be changed in the Table View, on the left-hand-side of the window). Statistics View also includes a measure of the mean difference in blood pressure and pulse rate between Awake and Asleep measurements—the average drop in pressure that the body exhibits between these two states—as expressed in mmHg and in percentages.
  • Page 51 SECTION 5 Concise vs. Detailed Reports When printing a report, select either a concise or detailed report. The concise report consists of the patient data, the statistical overview, and the diagnostic summary with any notes written by the interpreting physician. The format of this report cannot be altered.
  • Page 52 SECTION 5...
  • Page 53 CAUTION: Results of the ABPM procedure must be evaluated and interpreted by a trained and licensed healthcare practitioner. CAUTION: The Ambulo 2400 should NOT be used for measurement of blood pressure in neonates. CAUTION: The Ambulo 2400 may not provide accurate results in patients who have arrhythmias...

  • Page 54: Performing An Abpm Procedure

    SECTION 6 Start/Stop Button Press the Start/Stop button once to manually trigger a measurement. This function may be disabled via the software. During a measurement, whether triggered manually or automatically, press the Start/Stop button to immediately stop the measurement in progress and deflate the cuff. Press and hold the Start/Stop button for five seconds to put it in PAUSE mode.
  • Page 55 SECTION 6 Patient Hook-up Ideally, the patient should wear a loose-fitting, short-sleeved shirt or blouse for this procedure. Thick sweaters and dresses may complicate the hook-up of the device. Review the ABPM procedure with the patient, including the various parts and functions of the device which they will be wearing.
  • Page 56 SECTION 6 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) If using the EasyWear cuff, the cuff can be further secured on the patient’s arm using the snap and an ECG electrode.
  • Page 57 SECTION 6 Plug the device in to the air hose. The device can be clipped onto a belt or worn via the shoulder strap, depending upon which is more comfortable for the patient. With the shoulder strap, the device can be worn on the opposite side as the cuffed arm or the same side as the cuffed arm (depending on patient preference and comfort).

  • Page 58: Downloading And Reviewing Data Measurements

    SECTION 6 11. Before the patient leaves, carefully review all the information on the Patient Instruction Sheet. Specifically point out to the patient the position of the Start/Stop button, and ask them to PAUSE measurements when not wearing the device, or at the completion of the 24-hour procedure. Pausing is accomplished by holding down the Start/Stop button for five seconds.

  • Page 59: Troubleshooting And Maintenance

    USB cable and press the Start/Stop button to initiate a manual measurement. If the device still fails to take measurements, note any errors displayed on the LCD and refer to the Error and Diagnostic Codes section in this manual. Contact Mortara Technical Service for further assistance.

  • Page 60: Maintenance

    Ensure the batteries are in the correct polarity. • The device should power-on when the batteries are inserted correctly. Close the battery cover. The calibration check requires the following components: • Ambulo 2400 device • Sphygmomanometer or NIBP simulator • Y-connector air hose •...
  • Page 61 You can close this screen and continue using the Ambulo 2400. NOTE: If you determine and confirm that the Ambulo 2400’s pressure sensor requires calibration, please contact Mortara Technical Support or your Mortara representative to arrange for calibration service. This will require that you send the device to an authorized Service Center for calibration.
  • Page 62 APPENDIX A...

  • Page 63: Error And Diagnostic Codes

    ERROR AND DIAGNOSTIC CODES APPENDIX B The device can display a variety of error and diagnostic codes during or after measurements. Use this table to identify the source of error and the recommended solution. Code Description Cause & Suggested Solutions Err AP Could not determine the Mean Arterial Set initial top pressure to a higher value and/or...
  • Page 64 Overpressure Pressure exceeded threshold 0 (295 mmHg) for any duration Er 167 Calibration error Device has been incorrectly calibrated. Please recalibrate or contact Mortara Technical Service. Er 168 Calibration error Pressure sensor not calibrated, contact technical support Er 171 Device error Safety processor fault;...
  • Page 65 APPENDIX B Code Description Cause & Suggested Solutions HE 1 Device error Device error in retrieving device information, contact technical support HE 2 Device error Device error in saving data to device, contact technical support HE 16 Device error Data memory area reports incorrect length, contact technical support HE 17 Device error...
  • Page 66 The most common such occurrence is “SE 81” which means the date/time have been lost after the batteries have been removed for longer than 10 minutes. Pressing the Start/Stop button generally allows the user to continue past such soft errors. If an error condition persists, contact Mortara Technical Service.

  • Page 67: Patient Instruction And Diary

    PATIENT INSTRUCTION AND DIARY APPENDIX C Patient Instruction Your physician has recommended a 24-hour Ambulatory Blood Pressure Monitoring (ABPM) procedure for you. This is a relatively straight-forward procedure that measures your blood pressure over specific intervals during the day and night. ABPM may be done to get a more accurate measurement of your average blood pressure, or because you have different readings in the doctor’s office than at home, or for other reasons.
  • Page 68 APPENDIX C Typically, the monitor will take a reading every 15 minutes during the day, and every 30 minutes at night. While a reading is being taken, the cuff will inflate and squeeze your arm firmly, just as the blood pressure cuffs used in the office or in stores do.

  • Page 69: Patient Diary

    APPENDIX C Patient Diary Patient Name: Date: Physician: Nurse: Clinic Phone: After Hours: Day Intervals: Night Intervals: Start Time: Stop Time: Asleep Time: Awake Time: Time Notes Time Notes...
  • Page 70 APPENDIX C...

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