24-Hour Ambulatory BP Monitoring System

Changes This manual is identified as Part number: NV-54/NBP-ONE. An updated version may be available for download from the Norav Medical website. Should you notice errors or omissions in this manual, please notify us at: Norav Medical 601 N. Congress Ave. Suite 105, Delray Beach FL 33445, USA. Tel: +1 (561) 274-4242 Email: [email protected] This manual is for the NBP One, Ambulatory Blood Pressure Monitor (ABPM) System. 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...

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. In-clinic and home blood pressure measurements cannot provide the same depth of information that a 24-hour study provides. Several studies have shown that...

Introduction to Ambulatory Blood Pressure Monitoring Symbols Used in Labeling Symbol General Warning Sign Batch Code Refer to Instruction Manual Authorized representative in the European Community This product meets the requirements of the applicable Directives Disposal in compliance with WEEE Directive Serial Number CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician Cuff index line must fall within range markings Arrow should be placed over artery Symbol indicating limb circumference Index line Not made with natural rubber latex Reference Number This...

NBP One User Manual Fragile, handle with care Shipping and storage humidity should be kept between 15% to 95% Shipping and storage temperature should be kept between -20˚ C to 70˚C This product and its shipping container should be kept dry Norav Medical

Overview Indications for Use The NBP One System is a non-invasive oscillometric ambulatory blood pressure monitor that is intended to be used with NEMS Software for the recording and displaying of up to 250 measurements of systolic and diastolic blood pressure and heart rate. It is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure an adult and pediatric (> 3yrs.) patient’s systolic and diastolic blood pressures over an extended period of time. The system is only for measurement, recording, and display to assist a licensed physician in making a diagnosis....

Products and Accessories The NBP One System should contain the following items. If you are missing any item, please contact Norav Medical immediately (see Limited Warranty for contact information). NBP One ABPM System (Included Accessories) Item Description NBP One ABP Monitor NBP One Software Installation Media USB Cable ABP Monitor Belt ABP Monitor Shoulder Strap ABP Monitor Pouch ABPM Cuff, Size 2 (26cm-34cm) ABPM Cuff, Size 3 (32cm-44cm) ABPM Air Hose NBP One ABPM Optional Accessories Item Description Part Number ABPM Cuff Size 1 (18-26 cm) ABPM Cuff, Size 4 (42cm-55cm) Biocompatibility and...

Specifications Method of Measurement

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. • The monitor is intended for use following consultation and instruction by a physician. The reliability of the device is dependent upon conformance with the operation and service instructions, as detailed in this manual. This device has been designed for use on patients...

Warnings The general warning sign indicates a potentially hazardous situation which could result in serious injury. WARNING: Do not use in the presence of flammable anesthetics; this could cause an explosion. This device is not suitable for use in an oxygen enriched environment. WARNING: Do not immerse the monitor in any fluid, place fluids on top, or attempt to clean the monitor with any liquid detergents, cleaning agents, or solvents. This may cause an electrical hazard. Do not use the monitor if accidental wetting occurs; please return to Norav Medical (see Limited Warranty). Refer to Maintaining...

Cautions The caution symbol indicates a potentially hazardous situation which may result in minor or moderate injury. It may also be used to alert against unsafe practices. CAUTION: When downloading data from the monitor’s communications USB port, the device should not be in use with a patient. CAUTION: Do not remove monitor covers, except to replace batteries. The monitor does not contain any user serviceable components. Return monitor if service is required. CAUTION: Do not use on neonates, pediatric patients less than 3 years old, or patients known to be readily susceptible to bruising. CAUTION:...

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. CONTRAINDICATION: Do not use on patients with carotid or aortic valve stenosis. CONTRAINDICATION: The system is not applicable in generalized constriction or localized spasm of muscular conduit...

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. To Abort a Measurement: Press the Start/Stop button any time during a reading. To Start a Programmed ABP Study: When time is flashing, press the Start/Stop button to take 1st reading. To Start a Manual BP Reading: When clock is displayed, press the Start/Stop button. Male bayonet NIBP connector Event Marker Day/Night Button Time - Shown when the monitor is not taking a reading. Battery - Indicates low...