|
Source: VivoMetrics FAQ section
What is the LifeShirt™
System?
 The
LifeShirt ™System is a continuous ambulatory monitoring
system for collecting, analyzing and reporting health
data. The system's central component is the LifeShirt, a
comfortable, lightweight, washable garment with embedded
sensors that continuously collects information on a
range of cardiopulmonary parameters. Using the LifeShirt
System, researchers and clinicians can select the data
they need to obtain a fuller and more accurate view of
their patients' health, enabling them to make more
knowledgeable decisions, advance the quality of patient
care and reduce costs.
What is continuous ambulatory
monitoring?
Continuous ambulatory monitoring is the observation
of a patient's physiologic data over time while that
patient is outside the clinical setting (e.g., while the
patient is at home or at work).
How does the LifeShirt System
work?
Protected by 12 patents, the technology behind the LifeShirt System is poised to set the standard for
continuous ambulatory patient monitoring. At the heart
of the technology is a respiratory monitoring method
called inductive plethysmography, which enables
clinicians to capture a highly accurate view of a
patient's breathing. Combining this advanced monitoring
capability with simple-to-use, yet robust data
collection and reporting features, the LifeShirt System
enables clinicians to gain a more thorough understanding
of patients' health by capturing an ongoing "movie" of
physiologic data rather than episodic "snapshots"
collected during periodic office visits.
Based on clinically proven,
hospital-tested technology, the LifeShirt System
includes the following components:
LifeShirt garment:a lightweight (8 oz.), machine
washable, comfortable, easy-to-use shirt with embedded
sensors. To measure respiratory function, sensors are
woven into the shirt around the patient's chest and
abdomen. A three-lead, single channel ECG measures heart
rate, and a two-axis accelerometer records patient
posture and activity level. Optional peripheral devices
measure blood pressure and blood oxygen saturation.
LifeShirt Recorder™: a PDA that continuously encrypts
and stores the patient's physiologic data on a compact
flash memory card. Patients may also record time-stamped
symptom, mood and activity information in the recorder's
VivoLog™ Digital Diary, allowing researchers and
clinicians to correlate subjective patient input with
objectively measured physiologic parameters.
VivoLogic™ software. proprietary PC-based software
decrypts and processes recorded data using patented
algorithms. Includes viewing and reporting features that
enable researchers and clinicians to view the
full-disclosure, high-resolution waveforms or look at
trends over time. In addition, summary reports can be
generated that present processed data in concise,
easy-to-interpret graphical and numeric formats.
VivoMetrics Data Center: houses a staff of data
analysts that can conduct over-reads for customers who
do not want to process their data locally. Data can be
uploaded via the Internet or mailed to the Data Center
where they are processed using VivoLogic software. A
summary report is then generated and delivered via
e-mail, fax or mail, along with digital files containing
full-disclosure waveforms. The Data Center staff also
provides technical support for customers using VivoLogic
software on their personal computers.
What type of data does the
LifeShirt System collect?
The LifeShirt System is able to collect patient data
through various sensors, including respiratory bands,
which measure pulmonary function and an ECG, which
records electrical activity of the heart. In addition,
the system can measure and record blood pressure and
blood oxygen level with peripheral sensors that plug
into the LifeShirt Recorder. It also tracks and records
posture and activity information, and has an electronic
patient diary, the VivoLog™ Digital Diary, to record
subjective patient data about mood, symptoms and
activity. The system is designed to accommodate the
monitoring of additional parameters in future versions.
What is inductive
plethysmography?
As deployed in the LifeShirt System, inductive
plethysmography measures changes in the cross sectional
area of the rib cage and abdomen over time and applies a
series of proprietary algorithms to the data to
calculate the amount of air either inhaled or exhaled
during respiration. Two parallel, sinusoidal arrays of
insulated wires embedded in elastic bands are woven into
the LifeShirt, surrounding the rib cage and abdominal
areas of the torso. Extremely low voltage electrical
current is passed through the wire creating an
oscillating circuit. As the two body chambers expand and
contract, the electrical sensors generate different
magnetic fields that are converted into proportional
voltage changes over time (i.e., waveforms).
How does inductive
plethysmography differ from other monitoring techniques
such as impedence plethysmography?
By virtue of its design, inductive plethysmography
reduces the signal interference and distortion that is
often associated with other monitoring technologies,
enabling clinicians to obtain more accurate measurements
of respiration. For example, in contrast to impedance
pneumography, no electricity passes through the
monitored individual with inductive plethysmography.
How is the LifeShirt System
different from other ambulatory respiratory and cardiac
monitoring systems?
While there are ambulatory technologies capable of
measuring one parameter at a time, the LifeShirt System
is the only non-invasive continuous ambulatory
monitoring system that can simultaneously collect data
on cardiopulmonary function, subjective patient
experiences and other parameters and correlate them over
time. Inductive plethysmography, which is the
LifeShirt's foundation, surpasses other measurement
techniques because of its ability to measure respiratory
volumes quantitatively and to detect both central and
obstructive apnea (breathing cessation). In the future,
it is planned to monitor mechanical function of the
heart.
Home Sleep Diagnostics
 The
LifeShirt System improves the speed, quality and
cost-effectiveness of sleep studies by moving them from
the sleep lab to the comfort and privacy of patients'
own bedrooms.
As it seeks to establish continuous ambulatory
patient monitoring as the method of choice for data
collection and analysis in these critical markets,
VivoMetrics will also move to apply its technology to
additional areas, including disease monitoring, sports
medicine, and the military.
The LifeShirt can be used virtually anywhere and
anytime, during normal everyday activities at work,
home, play and during sleep. It cannot be used while
swimming or bathing.
FDA Status
VivoMetrics' 510(k) market clearance application has
been approved by the the Food & Drug Administration
(FDA). In Q4 2001, the company received European CE Mark
certification for the LifeShirt System as well as ISO
9001 registration, permitting it to be marketed in
Europe.
How was the LifeShirt System
developed?
Inductive plethysmography was originally developed in
the mid 1970s by Marvin Sackner, M.D. for the
RespitraceR System, which monitors respiration in a
hospital setting. In 1999, VivoMetrics acquired key
patents encompassing wearable sensor design and software
algorithms pertaining to inductive plethysmography
technology, and established a team of biomedical
engineers and medical device specialists to adapt
inductive plethysmography for ambulatory applications.
The company then integrated inductive plethysmography
with other ambulatory physiologic sensors, developed
accompanying data analysis software and brought all of
these components together to produce the LifeShirt
System.
Where can I get the
LifeShirt?
Please contact MSO at (201) 670-9999 for
information how you can get the LifeShirt in order to be
monitored for Sleep Apnea.
|
HOME
BUY NOW
CONTACT US
