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CareTaker™

CareTaker is a new Monitoring Device for the


Detection and Warning of Nocturnal Hypoglycemia,
Nocturnal Dip, Sleep Disorders, and Adherence and
Efficacy of Treatments.

CareTaker is a comfortable physiological monitor that


can be worn all night without disturbing sleep. It
tracks blood pressure beat by beat, heart rate, heart rate
variability, breathing rate, blood pressure variability,
hand temperature, and other parameters. The device is
the size of a bar of soap, fits in the palm of the hand, and records physiological
parameters for ten hours.

Bluetooth enabled, CareTaker has an embedded ARM processor that can diagnose
dangerous trends in physiological parameters, specifically nocturnal hypoglycemia, and,
if enabled, call for alarms when appropriate. CareTaker can communicate with cell
phones, computers, and PDAs.

CareTaker can detect dehydration and was recently used to detect and approximately
locate six aortic aneurisms that were later surgically repaired. After repair, CareTaker did
not detect any of the aneurisms. All this and
more is coming from just a finger cuff. The Primary Systolic Peak (#1)
amazing abilities of CareTaker are due to a Renal Reflection Peak (#2)
completely new way of detecting and
Iliac Reflection Peak (#3)
analyzing the pulse pressure wave form.
CareTaker works by detecting the arterial Re-reflection Peak (#4)

pulse at the finger using a comfortable, low Re-re-reflection Peak (#5)

pressure cuff. First the pressure wave form is


detected at the finger. The pulse is known to
consist of five individual pulses that 115 ms
172 ms

superpose to produce the wave form. The 193 ms 168 ms


first pulse is the ejection pulse from the 121 ms

heart. The next is a reflection or echo from 0.2 Seconds


the region of the aorta where the renal Arterial Pulse as detected by CareTaker
arteries leave. The third pulse is a reflection
from where the iliac arteries bifurcate. The fourth and fifth pulses are interesting, but not
presently used in any calculations. By using the amplitudes and arrival times relative to
the primary pulse, CareTaker detects many physiological parameters in real time for a
long time.

In its present form, CareTaker is the result of over a million dollars invested by the Office
of Naval Research for a simple device to monitor battlefield casualties. CareTaker was
shown to detect hemorrhaging, a major cause of death if untreated. Further funding has
been received from the National Heart Lung and Blood Institute of NIH. Current funding
is provided from the Office of the Secretary of Defense through ONR. Prototypes were
constructed through funding from OTTC/CCAT, California State University at San
Bernardino. Current prototypes have been sold to several countries and organizations in
the US. Empirical is presently engaged in a clinical trial at the University of Virginia,
which will establish, for FDA purposes, that CareTaker accurately tracks central blood
pressure beat by beat. Other tests are ongoing at the University of Texas Medical Branch,
Mayo Clinic, Winona University, University of British Columbia, University of Texas
Veteran’s Hospital in San Antonio, and California Institute of Technology. However, no
tests or interest has been associated with the protection of diabetics.

CareTaker can help people with diabetes because most type I and many type II diabetics
suffer from nocturnal hypoglycemia and CareTaker can detect physiological changes well
before the hypoglycemia becomes dangerous. Children often have no activation of the
sympathetic nervous system during nocturnal hypoglycemia meaning that they don’t
wake up. In type I adults, warning
signs such as headaches,
weakness, fatigue, confusion,
amnesia, blurred vision, focal
neurological deficits, seizures, and
coma are attenuated to the point
where patients become unaware.
Nocturnal hypoglycemia
decreases declarative memory in
type I patients. After nocturnal
hypoglycemia, there is often a
deterioration of mood, an increase
in hypoglycemia associated
autonomic failure leading to
CareTaker is small, light, and Bluetooth enabled. It works
increased risk of severe and
from a low pressure finger cuff that can be worn all night. prolonged hypoglycemia, and an
A newer design will fit inside the palm. increase in the QT interval leading
to polymorphic ventricular
tachycardia that can degenerate to fatal arrhythmias such as ventricular fibrillation.
These are only the direct problems of nocturnal hypoglycemia. Diabetics are known to
be at higher risk for heart and kidney disease. Poor sleep or absence of a nocturnal dip in
blood pressure is known to aggravate or cause hypertension, kidney failure, and obesity.
Yet, there are no physiological monitoring devices that can measure blood pressure
without waking the patient. It is perhaps an understatement to say that the largest
unsolved problem of diabetics is sleep management and monitoring. It is also an
understatement to say that the final frontier of health may well be the understanding and
management of sleep in general.

Beyond simple detection and warning of nocturnal hypoglycemia, CareTaker can manage
blood pressure during the day. Because diabetics are at increased risk due to
hypertension, frequent measurements are vital to its management. Anyone who is at risk
for nocturnal hypoglycemia should have a CareTaker especially those who sleep alone.

About Empirical Technologies Corporation

Empirical Technologies Corporation (ETC) is privately held Virginia Corporation


founded in 1995 for the purpose of developing new tools for monitoring of blood
pressure and the early detection of hemorrhaging. Beginning primarily as a research lab,
the company has developed a break through product, CareTaker, a multi-parameter
physiological monitor that allows for heartbeat by heartbeat monitoring of blood
pressure, heart rate and respiration rate, with trending and variability analysis. The data
produced can be stored, transmitted to other medical equipment or telemetered to remote
physicians for diagnostic or first responder support.

CareTaker technology has been clinically verified to be an accurate non-invasive beat by


beat vital signs monitor in a variety of tests conducted under approved protocols. The
CareTaker System requires no electrodes or wires and is Bluetooth enabled. It provides
real time information on physiological changes including occult hemorrhaging and the
rate of hemorrhaging.

CareTaker represents a major improvement in vital sign monitoring in that it most


directly represents the real time state of a patient. It is non-invasive and the finger cuff
required is much more comfortable than similar products. The company believes that it
will become the gold standard in monitoring equipment with potential buyers including
trauma and ambulance services for field monitoring, hospitals for ward and post-
procedure work, clinics, physician groups and private practitioners. The noninvasive
CareTaker could replace 70% to 90% of arterial catheters used during surgery or for
hemodynamic monitoring.

For more information contact:

David W. Gerdt, Ph.D.


President
Empirical Technologies Corporation
Phone: 434-296-7000
davidetc@firstva.com

The Palm Sized CareTaker for Sleep Applications


(now available in prototype form).