NIBP Simulator Limits with the Advantage OEM series

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.

Rationale for NIBP Research on Dialysis Patients

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.

Comparison of CAS Medical NIBP in the Medtronic LifePak 12 vs. SunTech Medical Advantage 2.0

For over 20 years, SunTech Medical has been a leading provider of Blood Pressure products. Our sole focus on blood pressure has allowed us to study various patient populations and to design equipment specific to their particular needs.

For several years we have focused on the prehospital market and the requirements of taking trustworthy blood pressure readings on these patients. The requirements are especially onerous due to the dynamic EMS environment and possible changes in a critical patient's physiology. One can expect reliability and accuracy from most well made instruments in perfect environments. Variability of patients aside, the field can be separated by how they perform in a real world environment encountered by EMS professionals.

A Controlled Laboratory Comparison of three NIBP Devices on Cats and Dogs

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.

Rationale for Clinical Monitors and Validation of the Oscillometric Method

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.

Improvements in Electromagnetic Compatibility for the Advantage OEM Module Series

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.

Clinical Evaluation of an Oscillometric NIBP Technology During Hemodialysis According to the British Hypertension Society Protocol

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.

Evaluation of a Non-Invasive Blood Pressure Monitoring Technology During Emergency Transport Conditions as Compared to the ProPaq LT

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.

Blood Pressure Monitoring in Air Ambulance Emergency Medical Services

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.