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Introduction

SunTech Medical has developed an NIBP technology for EMS transport applications by focusing on the unique challenges of obtaining reliable blood pressure readings in the emergency transport environment. In order to fairly compare and separate available technologies, an evaluation of performance was completed in conditions typically encountered by EMS professionals.

Methods

To evaluate SunTech Medical’s Advantage Transport Motion Tolerant (TMT) technology, we conducted a comparative trial against the CAS motion tolerant NIBP technology included with the Medtronic LIFEPAK 12 defibrillator.

Results

Assessment of systolic pressure, diastolic pressure and heart rate was comparable between the two systems, however, only the SunTech Medical Advantage with TMT technology produced a valid blood pressure result for each attempted reading while the LIFEPAK 12 failed to obtain a measurement on 9% of all attempts.

Conclusion

For complete NIBP performance and reliability in EMS transport applications, there is no better solution than the Advantage Transport Motion Tolerant (TMT) technology from SunTech Medical.

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SunTech Medical, Inc. is a leading global provider of blood pressure monitors and non-invasive blood pressure technologies (OEM). We have always recognized the need for highly specialized equipment for different markets and environments. Our sole focus on blood pressure for over twenty years has allowed us to study various patient populations and design equipment specific to the needs of that patient group.

While there are no formal veterinary regulatory requirements or guidelines, SunTech Medical, Inc. has recognized the need and obligation to study veterinary populations.

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Objectives

Monitoring of brachial blood pressure during exercise-electrocardiogram (ECG) testing is mandatory and changes in blood pressure (BP) can provide critical management evidence. Patient movement, mechanical vibration, artifactual sounds and observer variability make standard manual techniques problematic. This was an investigator-initiated study to assess an automated auscultatory technique of BP assessment [Tango exercise blood pressure monitor (SunTech Medical Instruments, NC, USA)] to adequately measure BP during stress-ECG testing.

Methods

Initially five fit young male volunteers underwent invasive right brachial artery BP recording using a low-compliance fluid-filled catheter with simultaneous manual and automated assessment. Secondarily, during exercise-ECG testing, the system was assessed against beat-to-beat brachial blood pressures obtained from a catheter-tip solid-state pressure manometer positioned in the ipsilateral brachial artery.

Results

In the supine study overall mean difference (+/-SEM) between invasive and manual blood pressures was 3.26 (1.53) and 3.89 (1.90) mmHg for diastolic BP (DBP) and systolic BP (SBP) respectively. Corresponding differences between invasive and automated results, and manual and automated were 3.68 (0.84) and -7.31 (1.83) mmHg, and -0.64 (+/-1.43) and -11.42 (+/-1.59) mmHg. During treadmill exercise-ECG testing the combined mean difference (+/-SEM) between invasive and automated SBP and DBP was 4.79 (+/-0.14) and 6.33 (+/-0.10) mmHg, respectively.

Conclusion

Automated BP assessment during exercise-ECG testing is feasible with the use of appropriate automatic devices likely to be at least as accurate as manual BP registration. The Tango device is tolerant to exercise and provides reliable automatic BP assessment with absolute differences within an acceptable clinical range.

(C) 2004 Lippincott Williams & Wilkins, Inc.

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According to the American Heart Association, nearly one third of adults have hypertension (defined as sustained high blood pressure of 140 /90 mmHg and above). Uncontrolled high blood pressure greatly increases the risk of heart disease and stroke - the first and third leading causes of death in developed nations. Because there are no symptoms, many people with hypertension do not know they have it. The only way to tell is to have an accurate check of your blood pressure.

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Similar to the pressure created by water flowing through a garden hose, blood pressure refers to the force exerted by circulating blood on the walls of our arteries and blood vessels. Blood pressure is commonly measured by inflating a cuff on the upper arm and watching the pressure indicated by a blood pressure gauge while listening to the Korotkoff sounds at the brachial artery with a stethoscope. The cuff must first be inflated enough to stop all the blood from flowing through the artery. Then, as the pressure in the cuff is gradually released with a valve, the occlusion of the artery is reduced. The point at which blood begins to flow again is signaled by the first Korotkoff sound. This is an indication of the peak blood pressure in the arteries and is referred to as systolic blood pressure. Continued reduction of the pressure in the cuff eventually allows the blood to flow completely unobstructed again. This point is signaled by the disappearance of the Korotkoff sounds and is considered a reliable indication of diastolic blood pressure.

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If you have ever used an automated monitor to measure blood pressure, you probably have encountered a reading you thought was too high. In these situations, clinicians usually take a measurement themselves using a sphygmomanometer and stethoscope to either confirm the reading or question whether the monitor is working properly. If the reading is confirmed, you and your patient may be surprised to realize that your patient’s BP is not what you expected. Alternatively, if the reading is different, you may wonder if your monitor is calibrated or operating correctly. Regardless of the situation, why is this happening at all?
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In recent years, ambulatory blood pressure monitoring (ABPM) has become a commonly used tool for the diagnosis and management of hypertension. Much of this growth was enhanced by the 2001 decision of the Center for Medicare and Medicaid Services (CMS) to begin reimbursement of ABPM for evaluation of “white-coat” hypertension. However, because of the focus on “white-coat” hypertension, there has been much confusion and misinformation as to whether ABPM is even a covered medical procedure. Understanding the clinical benefits and reimbursement of ABPM presents a valuable, yet often-missed opportunity for both physicians and sales representatives who might distribute these devices.
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Clinicians in emergency medical services (EMS), often times called emergency medical technicians (EMTs), have quite a difficult and complex job. Simply caring for patients in life and death circumstances is stressful. Add the burdens of retrieving patients in the field and transporting them to a hospital, and there are enough challenges to make it two jobs. These multi-layered difficulties are also posed of the medical equipment used in EMS. In air ambulance or aeromedical evacuation (Medevac) situations, these challenges are at their most extreme limits with high ambient noise making the gold standard of manual blood pressure (BP) measurement near impossible. It is certainly more problematic than having it measured during an annual checkup. Its performance, in terms of

  1. accuracy, or agreement with the standard,
  2. precision, or agreement with the sample mean,
    and
  3. trending, or agreement with the direction of change,

is often more critical given the higher level of acuity needed. Because clinicians need to focus on their patient, they rely on their equipment no matter how far from ideal the circumstances of measurement are. However, these circumstances are important and separate functional equipment that improves the care EMTs provide from that which makes it more burdensome. The following simulation study of BP monitors in an air ambulance 1) presents the current state of performance in patient monitoring and 2) details the difficulties that monitors encounter in a Medevac environment.

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Objectives

Existing concerns over the accuracy of automated blood pressure measurement on hemodialysis patients illustrates a need for a proven non-invasive blood pressure (NIBP) technology for monitoring during hemodialysis. We investigated an oscillometric blood pressure technology from SunTech Medical designed for end-stage renal disease (ESRD) patients during hemodialysis using a modified British Hypertension Society (BHS) protocol.

Methods

Evaluation of the AdvantageTM HDM NIBP monitoring technology from SunTech Medical was performed against manual auscultatory observer readings using the grading criteria of the British Hypertension Society protocol. 85 subjects were included in the study giving a total of 255 data pairs for comparison. Readings were made using simultaneous same-arm measurement with observers using a dual-head stethoscope and a calibrated mercury sphygmomanometer as a reference to the Advantage HDM technology.

Results

The mean differences and standard deviations were exceptionally close with -0.03± 5.4 and 0.44± 5.0 for systolic and diastolic blood pressure respectively. With 71% of all systolic blood pressure reference vs. technology differences equal to or less than 5mmHg, and 72% of all similar differences for diastolic pressure equal to or less than 5mmHg, the Advantage HDM technology received an A grade for both systolic and diastolic blood pressure measurement per the BHS grading criteria.

Conclusion

The Advantage HDM technology achieved an A/A grade for systolic and diastolic blood pressure measurement. As the population for this evaluation was exclusively ESRD patients during hemodialysis treatment, the Advantage HDM non-invasive blood pressure monitoring technology can be recommended for clinical use during hemodialysis.

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Blood Pressure Cuffs: Friend or Foe?
Authors: N. Walker, R. Gupta, J. Cheesbrough
Journal of Hospital Infection (2006); 63, 167–169

Nondisposable Sphygmomanometer Cuffs Harbor Frequent Bacterial
Colonization and Significant Contamination by Organic and Inorganic
Matter
Author: V. Base-Smith
American Association of Nurse Anesthetists Journal (1996); 64(2), 141–145

Blood Pressure Cuff as Potential Vector of Pathogenic Microorganisms: A
Prospective Study in a Teaching Hospital
Author: C. de Gialluly, C., V. Morange, E. de Gialluly, J. Loulergue, N. van der Mee, R. Qeuntin
Infection Control and Hospital Epidemiology (2006); 27(9), 940–943

Outbreak of Mupirocin-Resistant Staphylococcus Aureus on a
Dermatology Ward Associated with an Environmental Reservoir
Author: M.C. Layton, M. Perez, P. Heald, J. E. Patterson
Infection Control and Hospital Epidemiology (1993); 14(7), 369–375

Sphygmomanometers as a Reservoir of Pathogenic Bacteria
Author: M.A. Beard, A. McIntyre, P.M. Roundtree
Sphygmomanometers as a Reservoir of Pathogenic Bacteria (1969); 2, 758–760

The Microbial Flora of In-Use Blood Pressure Cuffs
Authors: M.G.M. Cormican, D. L., Low, P. Flynn, D. O’Toole
Irish Journal of Medical Sciences (1994): 4, 112–113

Show Abstract
Healthcare associated infections or HAIs, (also known as “hospital-acquired” infections or “nosocomial” infections), are bacterial infections that patients acquire while receiving treatment for other conditions within a healthcare setting.
More than 70% of the bacterial infections that cause HAIs are resistant to at least one of the drugs commonly used to treat these infections.3 The three most troublesome forms of HAIs are: Methicillinresistant Staphylococcus aureus (MRSA), Vancomycin-Resistant Enterococci (VRE), and Clostridium Difficile (C. diff). There is also a newly discovered bacteria called New Delhi metallo-ß-lactamase-1 (NDM-1) that has shown to be resistant to all know antibiotics at this time.6 These antibioticresistant pathogens are not only creating an important and growing threat to the public health, they are also imposing significant economic consequences on healthcare systems worldwide.
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Objectives

In most emergency transport environments, both patients and medical equipment are exposed to unstable circumstances due to the vehicle's movement and vibration. The noise and motion artifact generated often make it difficult to obtain a successful automated blood pressure reading. To address these complications, SunTech Medical has developed an oscillometric NIBP technology designed specifically for emergency transport applications. We performed a clinical evaluation of this technology and compared it to a recognized market leader for monitoring vital signs during emergency transport.

Methods

This clinical evaluation compared the performance of the AdvantageTM Transport Motion Tolerant (TMT) NIBP technology from SunTech Medical against blood pressure measurements made by the Welch Allyn ProPaq LT under emergency transport conditions. A total of 45 subjects participated in this study giving 450 total data points for inter-device comparison.

Results

The ProPaq LT provided successful blood pressure measurements on 96.2% of all attempts while the Advantage TMT technology achieved a higher measurement success rate of 98.4%. On average, the ProPaq LT required 42.6 ± 23.2 seconds to complete a successful reading, while the Advantage TMT technology achieved a quicker and more consistent average reading time of 36.3 ± 15.0 seconds. Both devices performed well when compared to manual reference readings, however the ProPaq LT showed standard deviations considerably higher than the Advantage TMT technology.

Conclusion

When tested under typical circumstances for emergency transport, the Advantage TMT NIBP technology consistently reported blood pressure readings at a quicker and more reliable rate than the ProPaq LT. The Advantage TMT also demonstrated significantly less variability than the ProPaq LT without compromising overall accuracy.

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Exercise stress testing began in the 1920s as researchers noticed changes in the ECG readings of patients suffering from angina. Over time and after thousands of examinations, clinicians were able to equate certain ECG waveform shapes and testing parameters (heart rate, blood pressure, exertion effort, and time) to abnormalities and pathologies. Today, the value of exercise stress testing for the prognostic assessment of patients is well accepted (Gibbons et al., 2002). In general terms, exercise stress testing is used to gauge how well the heart works when it has to pump harder and use more oxygen. As a patient walks on a treadmill or rides a stationary bike, exercise intensity is increased in order to mimic the strain placed on the heart when arteries are blocked or narrowed.

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For over 20 years, SunTech Medical, Inc. has been a leading provider of Blood Pressure technology to monitoring and defibulator companies. Our sole focus on blood pressure allows us to study various patient populations and to develop algorithms specific to the needs and environments of those patient groups. We are the only company with proprietary algorithms for auscultatory, oscillometric, stress, transport motion, patient motion, veterinary, dialysis, pediatric, neo-natal, ambulatory, geriatric, and bariatric applications. Our Advantage OEM Module Series provides for many of these applications in a single, robust platform.

Our monitors and modules are used in almost every environment where accurate BP is required. Each of these environments have different susceptibility and radiated emissions requirements. For instance, a pre-hospital transport device has need of a module with fewer emissions and reduced susceptibility than a home healthcare device. This is due to higher levels of Electromagnetic Interference (EMI) within the transport environment.

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When potential customers evaluate the Advantage NIBP module with a view to developing manufacturing procedures, often an NIBP simulation or group of simulations are performed using an NIBP simulator. Some will ask for expected values. These values are dependent on several factors including the type of simulator, settings, age of the instrument, software version, pneumatic setup and module configuration bytes. Thus it is difficult to provide meaningful min/max values without testing under identical conditions.

This application note provides general limits expected for 5 simulator brands at various settings. These limits were derived using specific equipment arranged in a precise manner. If these data are to be relied upon, we recommend the test conditions be replicated exactly. Even so, results may vary due to the vagaries of the specific instrument.

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Accurate and consistent monitoring of brachial blood pressure during ECG stress testing is both critical and difficult.  New techniques offer an improved analysis.

Copyright 2005: The International Review of Patient Care, SPG Media Group, PLC.

Show Abstract

SunTech Medical, Inc. is a leading global provider of blood pressure monitors and non-invasive blood pressure technologies (OEM). We have always recognized the need for highly specialized equipment for different markets and environments. Our sole focus on blood pressure for over twenty years has allowed us to study various patient populations and design equipment specific to the needs of that patient group.

We are the only company with proprietary algorithms for auscultatory, oscillometric, stress, transport motion, patient motion, veterinary, dialysis, pediatric, neo-natal, ambulatory, geriatric, and bariatric applications. Our Advantage series of modules accommodate many of these applications in a single, robust platform.

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SunTech Medical, Inc. has, for over 20 years, been a leading provider of clinical grade Blood Pressure monitors and OEM BP technologies. Our sole focus on blood pressure has allowed us to study various patient populations and design equipment specific to the needs and environments of those patient groups.

Over the past 5 years we have focused on the dialysis market and the special requirements of taking blood pressure readings on patients during dialysis treatment. The process of renal hemodialysis occasions significant fluid loss from the circulatory system, tissues and interstitial spaces. The affects range from loosening of the BP cuff (edema loss) to potential changes in pulse transmission characteristics. All can affect BP system accuracy. This clinical environment is further complicated because dialysis patients are known to have a higher incidence of cardiovascular issues. We have collected data and completed validations on patients undergoing dialysis. Analyzing these data has identified characteristics unique to and essential for tailoring a blood pressure system specific for this patient population.

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DAIC cover image

In DAIC,"Trends in ECG Stress Test Systems," July/August 2012 (PDF page 3)

Cardiac stress testing helps physicians diagnose various heart conditions and has become a vital diagnostic tool for all cardiac care facilities. A modern cardiac stress lab uses a digital electrocardiogram (ECG) stress system, sophisticated echocardiogram imaging, an electronically controlled treadmill/ ergometer, and usually a manual cuff and bulb sphygmomanometer. If everything else in the lab is automated and state-of-the-art, one might wonder why a blood pressure measurement tool from the 19th century is so prevalent in 21st century stress labs.

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Most people do not realize their blood pressure is constantly changing minute by minute in response to mood, activity, body position, etc. In fact, simple changes in your body, environment, and activities significantly impact your blood pressure and cause your blood pressure to fluctuate between 5 and 40 mmHg. It is important for medical professionals and patients to know factors that can temporarily cause significant deviations in blood pressure measurements to avoid misdiagnosis of hypertension and inappropriate prescriptions of anti-hypertension medications. Below is a list of 10 factors that can temporarily cause significant deviations in your blood pressure measurements.

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The accuracy of a blood pressure (BP) device or monitor is often determined by comparing its measurement relative to the measurement of an observer using a mercury sphygmomanometer and stethoscope on the same patient. The human observer with this setup in a controlled environment, with a meticulously prepared patient, and the practice of careful measurement is considered to be the gold standard of non-invasive blood pressure measurement. Measurements taken in this manner are the basis for the levels that are the current definitions of high BP or hypertension, 140/90, and normal BP, 120/801.

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Dental care professionals realize that the key component of any thorough dental hygiene appointment is patient assessment. While there are several tools used for conducting screenings and examinations for oral health, other aspects of patient health that may be related to dental heath are often overlooked. A patient's blood pressure is one of these parameters. Appropriate monitoring of blood pressure can not only improve outcomes of dental care, but also play a role in improving the overall health of patients.

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by Bruce Alpert, MD

Twenty-four hour ambulatory blood pressure monitoring (ABPM) has become a routine procedure in adult medicine over recent years. It provides physicians with the best estimate of true blood pressure and blood pressure variability. In the February 1997 issue of the Journal of Pediatrics, I wrote an editorial with Stephen Daniels, M.D., Ph.D., expressing the opinion that pediatricians needed to “catch-up” with adult physicians in their awareness of the uses and benefits of 24-hour ABPM.1 In that same issue, the largest series of children undergoing ABPM research to date, including 1141 adolescents was published by Soergel et al.2 This article presented guidelines for classifying normal and elevated systolic and diastolic BP levels during awake, asleep, and 24- hour time periods for children and adolescents. With these published guidelines, it was our hope that ABPM would become the standard of care for identifying and managing hypertension in pediatric patients. Unfortunately, eleven years after my original editorial, ABPM is still widely under-utilized by the pediatric healthcare community.