Norav Medical NBP One Operation Manual
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Norav Medical NBP One Operation Manual

24-hour ambulatory bp monitoring system
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OPERATION MANUAL
NBP One
24-Hour Ambulatory BP Monitoring System

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Summary of Contents for Norav Medical NBP One

  • Page 1 OPERATION MANUAL NBP One 24-Hour Ambulatory BP Monitoring System...

  • Page 2: Changes

    CAUTION: US Federal law restricts this device to sale by or on the order of a licensed practitioner Copyright Information All content in this manual is the proprietary information of Norav Medical and is provided solely for purposes of operation, maintenance or service of the NBP One ABPM system. This manual and the NBP One ABPM system described in it are protected under copyright law under which they may not be copied, in whole or in part, without written consent of Norav Medical.

  • Page 3: Table Of Contents

    MANAGING PATIENT STUDIES ..........................25 ..............................25 XPORTING A ATIENT TUDY ..............................25 MAILING A ATIENT TUDY EVENT CODES ................................26 MAINTAINING AND CLEANING THE NBP ONE ......................27 ............................ 27 AINTENANCE AND EPAIRS FTER ............................ 28 ALIBRATION ERIFICATION ROCEDURE LIMITED WARRANTY ..............................29 TECHNICAL ASSISTANCE............................

  • Page 4: Introduction To Ambulatory Blood Pressure Monitoring

    NBP One User Manual Introduction to Ambulatory Blood Pressure Monitoring Ambulatory blood pressure monitoring (ABPM) is an accepted clinical tool for collecting multiple blood pressure measurements. ABPM data is intended to better assist clinicians with the diagnosis and management of hypertension by providing data related to: blood pressure variability, estimation of true blood pressure, overnight changes in blood pressure, blood pressure load, sleep blood pressure dipping, and morning surge in blood pressure.

  • Page 5: Symbols Used In Labeling

    Introduction to Ambulatory Blood Pressure Monitoring Symbols Used in Labeling Symbol Description Standard/Source General Warning Sign ISO 7010-W001 Batch Code ISO 7000-2492 Caution ISO 7000-0434A Refer to Instruction Manual ISO 7010-M002 Authorized representative in the European Community ISO 15223-1 Industry Consult Instructions for Use ISO 7000-1641 This product meets the requirements of the applicable...
  • Page 6 NBP One User Manual Fragile, handle with care ISO 7000-0621 Shipping and storage humidity should be kept between 15% to ISO 7000-2620 Shipping and storage temperature should be kept between ISO 7000-0632 -20˚ C to 70˚C This product and its shipping container should be kept dry...

  • Page 7: Overview

    Device Operation The NBP One monitor is worn by the patient on a waist belt and is connected to a cuff around the non- dominant upper arm. The cuff is inflated automatically at intervals which can be programmed during setup. Blood pressure is measured by the oscillometric method which senses pressure waves in the artery when occluded by pressure in the cuff.

  • Page 8: Products And Accessories

    NBP-ONE-CUFF-1-01 ABPM Cuff, Size 4 (42cm-55cm) NBP-ONE-CUFF-1-04 Biocompatibility and Applied Parts The ABPM cuff is the only Applied Part (AP) of the NBP One system. All AP have been evaluated for biocompatibility in conjunction with the applicable standards. Norav Medical...

  • Page 9: Specifications

    Overview Specifications Method of Blood Pressure Range Systolic: 40-260 mmHg Diastolic: 25-200 mmHg Heart Rate Range 40-200 bpm Maximum Inflate 280 mmHg Pressure Accuracy Heart Rate accurate within +/-2% or +/-3 bpm, whichever is greater. Blood Pressure results meet or exceed ANSI/AAMI/ISO 81060-2:2013 standards for non- invasive accuracy: ±5 mmHg mean error &...

  • Page 10: Safety And Effectiveness Considerations

    Safety and Effectiveness Considerations The following safety and effectiveness issues are to be considered prior to the usage of the NBP One monitor. NOTE: This device is defibrillator protected No precautions specific to the NBP One are required during defibrillation, and defibrillation discharge has no effect on the NBP One.

  • Page 11: Warnings

    EMISSIONS or decreased IMMUNITY of ME EQUIPMENT or ME SYSTEM. WARNING: The NBP One may be interfered with by other equipment even if the other equipment complies with CISPR Emission Requirements. WARNING: Performance can be affected by extremes of temperature, humidity and altitude.

  • Page 12: Cautions

    Norav Medical. CAUTION: The NBP One does not contain any user serviceable internal parts and should only be repaired by an authorized Norav Medical service representative. Do not service the product while in use.

  • Page 13: Contraindications

    Contraindications The NBP One ABPM system should be used in conjunction with all other available medical histories and diagnostic test information about the patient. The following are reasons to withhold use of the NBP One ABPM system from a patient: CONTRAINDICATION: Do not use on patients with erratic, accelerated or mechanically controlled irregular heart rhythms, including patients with arrhythmias.

  • Page 14: Nbp One At A Glance

    NBP One User Manual NBP One At a Glance Device Figure 1: NBP One device Start/Stop Button To Power On: Press the Start/Stop button. To Power Off: When not taking a reading, press and HOLD the Start/Stop button until you hear 8 beeps (approx. 5 seconds), then release.

  • Page 15: Setting Up The Nbp One System

    Indicates the number of readings in memory. Setting Up The NBP One System Setting up the NBP One System involves powering the NBP One, installing NEMS Software on a personal computer (PC), and connecting the NBP One to the PC.

  • Page 16: Connecting The Nbp One To The Pc

    Communicating with the NBP One To successfully complete an ambulatory blood pressure (ABP) study: Connect the NBP One to the PC then program the study in the NEMS application from your PC. When the patient returns you will again use the NEMS application on your computer to retrieve the collected data.

  • Page 17: Conducting An Ambulatory Blood Pressure Study

    Fitting a Patient with the NBP One and ABPM Cuff After you have successfully programmed the NBP One using NEMS software, you may begin fitting the patient with the monitor and a blood pressure cuff. Cuffs may be used on either arm.
  • Page 18 Connect the BP hose to the device and the cuff Connect the BP hose to the NBP One monitor and to the cuff by pushing the fittings together until it is locked into place. The hose can be released by pulling the female fitting away from the male connection. Drape the hose over the patient’s shoulder, behind the neck and across to the opposite side of the body.

  • Page 19: Preparing And Educating The Patient

    The cuff will inflate and complete the BP measurement. The cuff will then be fully deflated. The clock icon should appear on the display of the NBP One indicating that the study is in progress. If problems occur, review the setup and fitting of the system.

  • Page 20: Finishing The Study

    If you wish to finish the study before the patient returns, instruct the patient to turn off the monitor by holding down the Start/Stop button for five (5) seconds. The NBP One will beep five (5) times and the display will turn off.

  • Page 21: Reviewing And Editing An Abp Study

    Reviewing and Editing an ABP Study Reviewing and Editing an ABP Study Each study in a patient file contains data that is displayed in the ABPM review screen. Return to Study Toolbar: Print, Export, Study Physician record list Report, email comments information Thresholds...
  • Page 22 NBP One User Manual Dia vs Sys (AASI Graph) The AASI Graph plots the diastolic on systolic BP values for each measurement captured in the study. Additionally, this tab lists the calculated AASI value, diastolic as a function of systolic, systolic as a function of diastolic, the correlation coefficient of the linear regression equation, and the coordinate of the average systolic and diastolic.
  • Page 23 Reviewing and Editing an ABP Study Bar Chart In this graph the following values of the test series will be displayed graphically as a function of time in a bar diagram: • Systolic values. Diastolic values. • The Heart Rate graph is represented by the red line. Figure 10: Bar Chart graph Pie Chart There is represented the Values Above Limit information.

  • Page 24: Reviewing An Ambulatory Blood Pressure Study

    NBP One User Manual Reviewing an Ambulatory Blood Pressure Study In the ABP Data view, you can review an ABP study for accuracy and context. Wrong measurements could be omitted from the analysis of the ABP study displayed in the BP Graphs and other views, but these readings can be printed in the report.

  • Page 25: Creating Reports

    Creating Reports Creating Reports Configuring and Customizing the Report To document a study and its findings, you can create a customized report which can include one or many of the following preconfigured report formats: • Patient Information. • BP Graph. •...

  • Page 26: Event Codes

    NOTE: Codes do not automatically indicate that a reading is invalid; they serve only as guides to help you review the data. Event Code Definitions Code Description in NBP One Software Solution or Response Weak or no oscillometric signal Check position and tightness of the cuff.

  • Page 27: Maintaining And Cleaning The Nbp One

    NBP One The NBP One monitor cannot be sterilized. DO NOT immerse the monitor in any fluid, or attempt to clean with any liquid detergents, cleaning agents, or solvents. You may use a soft, damp cloth to remove dirt and dust from the monitor.

  • Page 28: Calibration Verification Procedure

    Calibration Verification Procedure It is recommended that you check the accuracy of the NBP One once every two years. If needed, an authorized service center may recalibrate the pressure transducers in the monitor. To verify calibration, the NBP One must first be placed into the proper mode.

  • Page 29: Limited Warranty

    Norav Medical will repair any component(s) or part(s) that it finds to be defective during the period of this limited warranty. Should a defect become apparent, the original purchaser should notify Norav Medical of the suspected defect.

  • Page 30: Radio Frequency Compliance Requirements

    WARNING: The NBP One should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the NBP One should be observed to verify normal operation in the configuration in which it will be used.

  • Page 31: Electromagnetic Compatibility System Requirements

    The NBP One is intended for use in a Home Healthcare Environment within the electromagnetic environment specified below. The customer or the user of the NBP One should assure that it is used in such an environment. This equipment has been tested and found to comply with the limits for medical devices to IEC60601-1-2: 2014.
  • Page 32 NBP One User Manual Surge IEC 61000-4-5 Power Frequency 30A/m Power Frequency magnetic fields should be at All device (50Hz) magnetic field levels characteristic of a typical location in a input and IEC 61000-4-8 Home Healthcare Environment or domestic output...
  • Page 33 Electromagnetic Compatibility System Requirements For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

  • Page 34: Product Disposal

    Battery Disposal The Norav Medical NBP One contains a small lithium ion battery on a Printed Circuit (PC) board that contain materials which may be hazardous to human health. The battery cannot be easily removed and therefore the NBP One must be disposed of in an environmentally responsible way or returned to Norav Medical.

  • Page 35: References

    References References Pickering TG, Shimbo, D, Haas D. Ambulatory Blood-Pressure Monitoring. New England Journal of Medicine 2006; 354(22): 2368-2374. Marchiando RJ, Elston MP. Automated Ambulatory Blood Pressure Monitoring: Clinical Utility in the Family Practice Setting. American Family Physician 2003; 67(11): 2343-2350. White WB.

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