Wrist-Mounted Vital Signs Monitor from Empirical Technologies CareTaker® is a wrist mounted complete vital signs monitor weighing 105 grams. It has been validated against over 400 hours of radial and central catheters to track beat by beat blood pressure (cNIBP) and ECG accurate heart rate. Additional trials verified that CareTaker detects blood loss of one pint. Other trials showed that CareTaker measures respiration rate and beat by beat arterial stiffness. Two modifications in prototype production allow the tracking of SpO2 and near-core body temperature. CareTaker uses a low pressure, below diastole, skin friendly polyurethane cuff around a finger or thumb and, for SpO2, a separate distal finger cuff. Temperature is taken in the axilla using a small patch and Bluetooth low energy (BLE) to transmit the temperature every minute for a week whereupon the patch is disposed. CareTaker slaves up to eight BLE enabled device such as a bathroom scale, glucometer, or future biomedical devices for specific disease identification. The heart rate function allows determination of all arrhythmias such as atrial fibrillation, but without the electrodes that, when removed, often tear the skin of older people. The new prototypes contain a cellular radio that reaches 99% of the US population. Simply by putting the cuff on and pushing a button, all five vital signs and others are continuously transmitted through a HIPAA data tunnel to a secure server. No confusing cell phones connections or pairings are necessary nor any hubs or extra equipment. The device works as well at home as on the interstate highways; one device does it all. Cloud data is available through Apps that are downloaded to cell phones, PCs, and tablets. Both real time and trend data, from home sleep studies for instance, are instantly available to qualified caregivers. All data is locally processed using an on-board ARM processor so that the data rate is almost zero, dramatically lowering subscription costs. A battery charge lasts for over 15 hours. SpO2 is only measured every 20 seconds and the pulse rate is not measured using the oximeter since it excessively uses battery energy and the results are not good enough for heart rate variability. CareTaker will cost as much as a smart phone and can be carried around in a purse or pocket. For sleep studies it should replace polysomnography, determine the nocturnal dip, and discover dangerous and prevalent nocturnal hypertension. CareTaker is a complete vital signs monitor with real time observation at any distance, greatly reducing emergency room visits. There is solid evidence that CareTaker can enable predictive cardiology. In a small blind trial, CareTaker detected and located five of five aortic aneurisms. The theory behind CareTaker is new, but supported in peer reviewed literature. Basically CareTaker decomposed each pulse arriving at the finger into several constituent pulses that occur due to partial pulse reflections near the renal arteries at the aorta and another at the iliac artery bifurcation. It was developed using SBIR funding for combat casualty care from the Office of Naval Research and the Office of the Secretary of Defense.
Neural Control of Vascular Reactions: Impact of Emotion and Attention Hadas Okon-Singer, Jan Mehnert, Jana Hoyer, Lydia Hellrung, Herma Lina Schaare, Juergen Dukart and Arno Villringer Journal of Neuroscience 19 March 2014, 34 (12) 4251-4259; DOI: https://doi.org/10.1523/JNEUROSCI.0747-13.2014 ABSTRACT This study investigated the neural regions involved in blood pressure reactions to negative stimuli and their possible modulation by attention. Twenty-four healthy human subjects (11 females; age = 24.75 ± 2.49 years) participated in an affective perceptual load task that manipulated attention to negative/neutral distractor pictures. fMRI data were collected simultaneously with continuous recording of peripheral arterial blood pressure（CareTaker 、Emperical Technologies）;. A parametric modulation analysis examined the impact of attention and emotion on the relation between neural activation and blood pressure reactivity during the task. When attention was available for processing the distractor pictures, negative pictures resulted in behavioral interference, neural activation in brain regions previously related to emotion, a transient decrease of blood pressure, and a positive correlation between blood pressure response and activation in a network including prefrontal and parietal regions, the amygdala, caudate, and mid-brain. These effects were modulated by attention; behavioral and neural responses to highly negative distractor pictures (compared with neutral pictures) were smaller or diminished, as was the negative blood pressure response when the central task involved high perceptual load. Furthermore, comparing high and low load revealed enhanced activation in frontoparietal regions implicated in attention control. Our results fit theories emphasizing the role of attention in the control of behavioral and neural reactions to irrelevant emotional distracting information. Our findings furthermore extend the function of attention to the control of autonomous reactions associated with negative emotions by showing altered blood pressure reactions to emotional stimuli, the latter being of potential clinical relevance. INTRODUCTION Threatening stimuli prototypically facilitate adaptive motor behavior and activate the autonomic nervous system, affecting heart rate and blood pressure (Lang et al., 2000). These vascular responses can aggravate when the threatening situation develops into stress for the organism. It has been shown that, among healthy subjects, those with higher blood pressure responses are more likely to
Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Dated: February 16, 2016 Received: February 17, 2016 CareTaker Wireless Vital Signs Monitor Indications for Use (Describe) CareTaker is intended to noninvasively and continuously measure a patient’s blood pressure (“BP”) and heart rate (“HR”), which are derived from the pulse pressure waveform using the scientific method of Pulse Decomposition Analysis (“PDA”) for use on adult patients at rest. CareTaker is calibrated using a manual sphygmomanometer. All parameters derived by CareTaker are reported to a remote display monitor via standard radio transmission. CareTaker does not provide any physiological alarm functions. The device is intended for use by clinicians or other properly trained medical personnel in a hospital or Trade Name: CareTaker Wireless Vital Signs Monitor Common Name: CareTaker Continuous Non‐Invasive Blood Pressure Monitor Device Description: _CareTaker is a cardiovascular monitoring device that noninvasively measures continuous blood pressure and heart rate via a finger cuff based on the scientific method of Pulse Decomposition Analysis (“PDA”) Intended Use: CareTaker is intended to noninvasively and continuously measure a patient’s blood pressure (“BP”) and heart rate (“HR”), which are derived from the pulse pressure waveform using the scientific method of Pulse Decomposition Analysis (“PDA”) for use on adult patients at rest. CareTaker is calibrated using a manual sphygmomanometer. All parameters derived by CareTaker are reported to a remote display monitor via standard radio transmission. CareTaker does not provide any physiological alarm functions. Device is intended for use by clinicians or other properly trained medical personnel in a hospital or other appropriate clinical setting. 8) Comparison to Predicate: Both the CareTaker and the NextFin predicate device are continuous non‐invasive blood pressure and heart rate monitors that derive these physiological parameters from the arterial pulse collected by a finger cuff. The devices are characterized by the following common features and differences: • Both devices measure blood pressure within AAMI SP‐10 (AAMI/ANSI/ISO 81060)
BMC Anesthesiol. 2017; 17: 48. Published online 2017 Mar 21. Continuous Non-invasive finger cuff CareTaker® comparable to invasive intra-arterial pressure in patients undergoing major intra-abdominal surgery Irwin Gratz,1 Edward Deal,1 Francis Spitz,1 Martin Baruch,2 I. Elaine Allen,3 Julia E. Seaman,4 Erin Pukenas,1 and Smith Jeancorresponding author1 Abstract Background Despite increased interest in non-invasive arterial pressure monitoring, the majority of commercially available technologies have failed to satisfy the limits established for the validation of automatic arterial pressure monitoring by the Association for the Advancement of Medical Instrumentation (AAMI). According to the ANSI/AAMI/ISO 81060–2:2013 standards, the group-average accuracy and precision are defined as acceptable if bias is not greater than 5 mmHg and standard deviation is not greater than 8 mmHg. In this study, these standards are used to evaluate the CareTaker® (CT) device, a device measuring continuous non-invasive blood pressure via a pulse contour algorithm called Pulse Decomposition Analysis.