throbber
DECLARATION OF GORDON MACPHERSON
`
`I, Gordon MacPherson, am over twenty-one (21) years of age. I have never been
`convicted of a felony, and I am fully competent to make this declaration. I declare the following
`to be true to the best of my knowledge, information and belief:
`
`1.
`
`2.
`
`3.
`
`I am Director Board Governance & IP Operations of The Institute of Electrical and
`Electronics Engineers, Incorporated (“IEEE”).
`
`IEEE is a neutral third party in this dispute.
`
`I am not being compensated for this declaration and IEEE is only being reimbursed
`for the cost of the article I am certifying.
`
`4. Among my responsibilities as Director Board Governance & IP Operations, I act as a
`custodian of certain records for IEEE.
`
`5.
`
`I make this declaration based on my personal knowledge and information contained
`in the business records of IEEE.
`
`6. As part of its ordinary course of business, IEEE publishes and makes available
`technical articles and standards. These publications are made available for public
`download through the IEEE digital library, IEEE Xplore.
`
`7.
`
`It is the regular practice of IEEE to publish articles and other writings including
`article abstracts and make them available to the public through IEEE Xplore. IEEE
`maintains copies of publications in the ordinary course of its regularly conducted
`activities.
`
`8. The article below has been attached as Exhibit A to this declaration:
`
`A. Y. Mendelson, R. J. Duckworth, and G. Comtois, “A Wearable Reflectance
`Pulse Oximeter for Remote Physiological Monitoring”, 2006 International
`Conference of the IEEE Engineering in Medicine and Biology Society,
`August 30, 2006 - September 3, 2006.
`
`9.
`
`I obtained a copy of Exhibit A through IEEE Xplore, where it is maintained in the
`ordinary course of IEEE’s business. Exhibit A is a true and correct copy of the
`Exhibit, as it existed on or about April 30, 2021.
`
`445 Hoes Lane Piscataway, NJ 08854
`
`DocuSign Envelope ID: 3595DB4B-1765-4589-8185-7AD82F0E2BC1
`
`1
`
`APPLE 1039
`Apple v. Masimo
`IPR2020-01521
`
`

`

`10. The article and abstract from IEEE Xplore shows the date of publication. IEEE
`Xplore populates this information using the metadata associated with the publication.
`
`11. Y. Mendelson, R. J. Duckworth, and G. Comtois, “A Wearable Reflectance Pulse
`Oximeter for Remote Physiological Monitoring” was published in the 2006
`International Conference of the IEEE Engineering in Medicine and Biology Society.
`The 2006 International Conference of the IEEE Engineering in Medicine and Biology
`Society was held from August 30, 2006 - September 3, 2006. Copies of the
`conference proceedings were made available no later than the last day of the
`conference. The article is currently available for public download from the IEEE
`digital library, IEEE Xplore.
`
`12. I hereby declare that all statements made herein of my own knowledge are true and
`that all statements made on information and belief are believed to be true, and further
`that these statements were made with the knowledge that willful false statements and
`the like are punishable by fine or imprisonment, or both, under 18 U.S.C. § 1001.
`
`I declare under penalty of perjury that the foregoing statements are true and correct.
`
`Executed on:
`
`DocuSign Envelope ID: 3595DB4B-1765-4589-8185-7AD82F0E2BC1
`
`5/3/2021
`
`2
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`EXHIBIT A
`
`DocuSign Envelope ID: 3595DB4B-1765-4589-8185-7AD82F0E2BC1
`
`3
`
`

`

`IEEE.org
`
`IEEE Xplore
`
`IEEE-SA
`
`IEEE Spectrum
`
`More Sites
`
`SUBSCRIBE
`
`SUBSCRIBECart Create Account
`
`Personal Sign In
`
`Browse
`
`My Settings
`
`Help
`
`Institutional Sign In
`
`Institutional Sign In
`
`All
`
`Conferences > 2006 International Conference...
`
`ADVANCED SEARCH
`
`A Wearable Reflectance Pulse Oximeter for Remote Physiological
`Monitoring
`Publisher: IEEE
`
`PDF
`
`Cite This
`
` << Results
`
`Y. Mendelson ; R. J. Duckworth ; G. Comtois All Authors
`
`52
`Paper
`Citations
`
`35
`Patent
`Citations
`
`1303
`Full
`Text Views
`
`Alerts
`
`Manage
`Content Alerts
`
`Add to Citation
`Alerts
`
`Abstract
`
`Document Sections
`
`I.
`
`Introduction
`
`II. System
`Architecture
`
`III.
`
`In Vivo
`Evaluations
`
`IV. Discussion
`
`V. Conclusion
`
`Authors
`
`Figures
`
`References
`
`Citations
`
`Keywords
`
`Metrics
`
`Abstract:To save life, casualty care requires that trauma injuries are accurately and
`expeditiously assessed in the field. This paper describes the initial bench testing of a
`wire... View more
`
`Metadata
`Abstract:
`To save life, casualty care requires that trauma injuries are accurately and expeditiously
`assessed in the field. This paper describes the initial bench testing of a wireless
`wearable pulse oximeter developed based on a small forehead mounted sensor. The
`battery operated device employs a lightweight optical reflectance sensor and
`incorporates an annular photodetector to reduce power consumption. The system also
`has short range wireless communication capabilities to transfer arterial oxygen
`saturation (SpO ), heart rate (HR), body acceleration, and posture information to a
`2
`PDA. It has the potential for use in combat casualty care, such as for remote triage, and
`by first responders, such as firefighters
`
`Published in: 2006 International Conference of the IEEE Engineering in Medicine and
`Biology Society
`
`Date of Conference: 30 Aug.-3 Sept. 2006 INSPEC Accession Number: 9220069
`
`DOI: 10.1109/IEMBS.2006.260137
`
`Export to
`
`Collabratec
`
`Downl
`PDF
`
` Back to Results
`
`More
`Like
`This
`Development of an Implantable
`Pulse Oximeter
`IEEE Transactions on Biomedical
`Engineering
`Published: 2008
`Wearable System for Monitoring of
`Oxygen Concentration in Breath
`Based on Optical Sensor
`IEEE Sensors Journal
`Published: 2015
`Show
`More
`4
`
`
`
`
`
`
`
`
`
`
`
`

`

`More Like This
`
`Date Added to IEEE Xplore: 15 December
`2016
`
`Publisher: IEEE
`
`Print ISBN:1-4244-0032-5
`
`Print ISSN: 1557-170X
`
`Conference Location: New York, NY, USA
`
`PubMed ID: 17946007
`Y. Mendelson
`Department of Biomedical Engineering, Worcester Polytechnic Institute, Worcester, MA,
`USA
`
`R. J. Duckworth
`Department of Electrical and Computer Engineering, Worcester Polytechnic Institute,
`Worcester, MA, USA
`
`G. Comtois
`Department of Biomedical Engineering, Worcester Polytechnic Institute, Worcester, MA,
`USA
`
` Contents
`
`I. Introduction
`Steady advances in noninvasive physiological sensing, hardware
`miniaturization, and wireless communication are leading to the
`development of new wearable technologies that have broad and
`important implications for civilian and military applications [1]–[2]. For
`example, the emerging development of compact, low-power, small-size,
`light-weight, and unobtrusive wearable devices may facilitate remote
`noninvasive monitoring of vital signs from soldiers during training
`exercises and combat. Telemetry of physiological information via a
`short-range wirelessly-linked personal area network can also be useful
`for firefighters, hazardous material workers, mountain climbers, or
`emergency first-responders operating in harsh and hazardous
`Sign in to Continue Reading
`environments. The primary goals of such a wireless mobile platform
`would be to keep track of an injured person's vital signs, thus readily
`allowing the telemetry of physiological information to medical providers,
`and support emergency responders in making critical and often life
`saving decisions in order to expedite rescue operations. Having
`wearable physiological monitoring could offer far-forward medics
`numerous advantages, including the ability to determine a casualty's
`condition remotely without exposing the first responders to increased
`risks, quickly identifying the severity of injuries especially when the
`injured are greatly dispersed over large geographical terrains and often
`out-of-site, and continuously tracking the injured condition until they
`arrive safely at a medical care facility.
`
`Authors
`
`Y. Mendelson
`Department of Biomedical Engineering, Worcester Polytechnic Institute, Worcester,
`MA, USA
`
`R. J. Duckworth
`Department of Electrical and Computer Engineering, Worcester Polytechnic
`Institute, Worcester, MA, USA
`
`G. Comtois
`Department of Biomedical Engineering, Worcester Polytechnic Institute, Worcester,
`MA, USA
`
`5
`
`
`

`

`Figures
`
`References
`
`Citations
`
`Keywords
`
`Metrics
`
`IEEE Personal Account
`
`Purchase Details
`
`Profile Information
`
`Need Help?
`
`Follow
`
`CHANGE USERNAME/PASSWORD
`
`PAYMENT OPTIONS
`
`COMMUNICATIONS PREFERENCES
`
`US & CANADA: +1 800 678 4333
`
`VIEW PURCHASED DOCUMENTS
`
`PROFESSION AND EDUCATION
`
`WORLDWIDE: +1 732 981 0060
`
`TECHNICAL INTERESTS
`
`CONTACT & SUPPORT
`
`About IEEE Xplore | Contact Us | Help | Accessibility | Terms of Use | Nondiscrimination Policy | Sitemap | Privacy & Opting Out of Cookies
`A not-for-profit organization, IEEE is the world's largest technical professional organization dedicated to advancing technology for the benefit of humanity.
`
`© Copyright 2021 IEEE - All rights reserved. Use of this web site signifies your agreement to the terms and conditions.
`
`IEEE Account
`
`Purchase Details
`
`Profile Information
`
`Need Help?
`
`» Change Username/Password
`» Update Address
`
`» Payment Options
`» Order History
`» View Purchased Documents
`
`» Communications Preferences
`» Profession and Education
`» Technical Interests
`
`» US & Canada: +1 800 678 4333
`» Worldwide: +1 732 981 0060
`» Contact & Support
`
`
`About IEEE Xplore Contact Us
`|
`
`
`|
`
`Help
`
`
`|
`
`Accessibility
`
`
`|
`
`Terms of Use
`
`
`|
`
`Nondiscrimination Policy
`
`
`|
`
`Sitemap
`
`
`|
`
`Privacy & Opting Out of Cookies
`
`A not-for-profit organization, IEEE is the world's largest technical professional organization dedicated to advancing technology for the benefit of humanity.
`© Copyright 2021 IEEE - All rights reserved. Use of this web site signifies your agreement to the terms and conditions.
`
`6
`
`  
`
`
`
`
`
`

`

`Proceedings of the 28th IEEE
`EMBS Annual International Conference
`New York City, USA, Aug 30-Sept 3, 2006
`
`ThB14.4
`
`A Wearable Reflectance Pulse Oximeter for Remote Physiological
`Monitoring
`Y. Mendelson*, Member, IEEE, R. J. Duckworth, Member, IEEE, and G. Comtois, Student Member, IEEE
`
`Abstract—To save life, casualty care requires that trauma
`injuries are accurately and expeditiously assessed in the field.
`This paper describes the initial bench testing of a wireless
`wearable pulse oximeter developed based on a small forehead
`mounted sensor. The battery operated device employs a
`lightweight optical reflectance sensor and incorporates an
`annular photodetector to reduce power consumption. The
`system also has
`short range wireless communication
`capabilities to transfer arterial oxygen saturation (SpO2), heart
`rate (HR), body acceleration, and posture information to a
`PDA. It has the potential for use in combat casualty care, such
`as for remote triage, and by first responders, such as
`firefighters.
`
`S
`
`I. INTRODUCTION
`TEADY advances in noninvasive physiological sensing,
`hardware miniaturization, and wireless communication
`leading
`to
`the development of new wearable
`are
`technologies that have broad and important implications for
`civilian and military applications [1]-[2]. For example, the
`emerging development of compact, low-power, small-size,
`light- weight, and unobtrusive wearable devices may
`facilitate remote noninvasive monitoring of vital signs from
`soldiers during training exercises and combat. Telemetry of
`physiological information via a short-range wirelessly-linked
`personal area network can also be useful for firefighters,
`hazardous material workers, mountain climbers, or
`emergency first-responders operating in harsh and hazardous
`environments. The primary goals of such a wireless mobile
`platform would be to keep track of an injured person’s vital
`signs, thus readily allowing the telemetry of physiological
`information to medical providers, and support emergency
`responders in making critical and often life saving decisions
`in order to expedite rescue operations. Having wearable
`physiological monitoring could offer far-forward medics
`numerous advantages, including the ability to determine a
`casualty’s condition remotely without exposing the first
`
`Manuscript received April 3, 2006. This work is supported by the U.S.
`Army Medical Research and Material Command under Contract No.
`DAMD17-03-2-0006. The views, opinions and/or findings are those of the
`author and should not be construed as an official Department of the Army
`position, policy, or decision, unless so designated by other documentation.
`*Corresponding author – Y. Mendelson is a Professor in the Department
`of Biomedical Engineering, Worcester Polytechnic Institute, Worcester,
`MA 01609 USA (phone: 508-831-5103; fax: 508-831-5541; e-mail:
`ym@wpi.edu).
`R. J. Duckworth is a Professor in the Department of Electrical and
`Computer Engineering, Worcester Polytechnic Institute, Worcester, MA
`01609 USA (rjduck@ece.wpi.edu).
`G. Comtois is a M. S. student in the Department of Biomedical
`Engineering, Worcester Polytechnic Institute, Worcester, MA 01609 USA
`(comtoisg@wpi.edu).
`
`the
`identifying
`increased risks, quickly
`to
`responders
`severity of injuries especially when the injured are greatly
`dispersed over large geographical terrains and often out-of-
`site, and continuously tracking the injured condition until
`they arrive safely at a medical care facility.
`Several technical challenges must be overcome to address
`the unmet demand for long-term continuous physiological
`monitoring in the field. In order to design more compact
`sensors and improved wearable instrumentation, perhaps the
`most critical challenges are to develop more power efficient
`and
`low-weight devices. To become effective,
`these
`technologies must also be robust, comfortable to wear, and
`cost-effective. Additionally, before wearable devices can be
`used effectively in the field, they must become unobtrusive
`and should not hinder a person’s mobility. Employing
`commercial off-the-shelf (COTS) solutions, for example
`finger pulse oximeters to monitor blood oxygenation and
`heart rate, or standard adhesive-type disposable electrodes
`for ECG monitoring, is not practical for many field
`applications because they limit mobility and can interfere
`with normal tasks.
`A potentially attractive approach to aid emergency
`medical teams in remote triage operations is the use of a
`wearable pulse oximeter to wirelessly transmit heart rate
`(HR) and arterial oxygen saturation (SpO2) to a remote
`location. Pulse oximetry is a widely accepted method that is
`used for noninvasive monitoring of SpO2 and HR. The
`method is based on spectrophotometric measurements of
`changes in the optical absorption of deoxyhemoglobin (Hb)
`Noninvasive
`(HbO2).
`and
`oxyhemoglobin
`spectrophotometric measurements of SpO2 are performed in
`the visible (600-700nm) and near-infrared (700-1000nm)
`spectral regions. Pulse oximetry also relies on the detection
`of photoplethysmographic (PPG) signals produced by
`variations in the quantity of arterial blood that is associated
`with periodic contractions and relaxations of the heart.
`Measurements can be performed in either transmission or
`reflection modes. In transmission pulse oximetry, the sensor
`can be attached across a fingertip, foot, or earlobe. In this
`configuration,
`the
`light emitting diodes (LEDs) and
`photodetector (PD) in the sensor are placed on opposite sides
`of a peripheral pulsating vascular bed. Alternatively, in
`reflection pulse oximetry, the LEDs and PD are both
`mounted side-by-side on the same planar substrate to enable
`readings from multiple body
`locations where
`trans-
`illumination measurements are not feasible. Clinically,
`forehead reflection pulse oximetry has been used as an
`alternative approach to conventional transmission-based
`
`1-4244-0033-3/06/$20.00 ©2006 IEEE.
`
`912
`
`Authorized licensed use limited to: IEEE Staff. Downloaded on April 30,2021 at 16:26:29 UTC from IEEE Xplore. Restrictions apply.
`
`7
`
`

`

`system can be programmed to alert on alarm conditions,
`such as sudden trauma, or physiological values out of their
`normal range. It also has the potential for use in combat
`casualty care, such as for remote triage, and for use by first
`responders, such as firefighters.
`Key features of this system are small-size, robustness, and
`low-power consumption, which are essential attributes of
`wearable physiological devices, especially for military
`applications. The system block diagram (Fig. 2), is described
`in more detail below.
`
`oximetry when peripheral circulation to the extremities is
`compromised.
`Pulse oximetry was initially intended for in-hospital use
`on patients undergoing or recovering from surgery. During
`the past few years, several companies have developed
`smaller pulse oximeters, some including data transmission
`via telemetry, to further expand the applications of pulse
`oximetry. For example, battery-operated pulse oximeters are
`now attached to patients during emergency transport as they
`are being moved from a remote location to a hospital, or
`between hospital wards. Some companies are also offering
`smaller units with improved electronic filtering of noisy
`PPG signals.
`Several reports described the development of a wireless
`pulse oximeter that may be suitable for remote physiological
`monitoring
`[3]-[4]. Despite
`the steady progress
`in
`miniaturization of pulse oximeters over the years, to date,
`the most significant limitation is battery longevity and lack
`of telemetric communication. In this paper, we describe a
`prototype forehead-based reflectance pulse oximeter suitable
`for remote triage applications.
`
`II. SYSTEM ARCHITECTURE
`The prototype system, depicted in Fig. 1, consists of a
`body-worn pulse oximeter that receives and processes the
`PPG signals measured by a small (φ = 22mm) and
`lightweight (4.5g) optical reflectance transducer. The system
`
`Fig. 2. System block diagram of the wearable, wireless, pulse oximeter.
`Sensor Module (top), Receiver Module (bottom).
`
`Sensor Module: The Sensor Module contains analog signal
`processing circuitry, ADC, an embedded microcontroller,
`and a RF transceiver. The unit is small enough so the entire
`module can be integrated into a headband or a helmet. The
`unit is powered by a CR2032 type coin cell battery with
`220mAh capacity, providing at least 5 days of operation.
`Receiver Module: The Receiver Module contains an
`embedded microcontroller,
`RF
`transceiver
`for
`communicating with the Sensor Module, and a Universal
`Asynchronous Receive Transmit (UART) for connection to
`a PC. Signals acquired by the Sensor Module are received by
`the embedded microcontroller which synchronously converts
`the corresponding PD output to R and IR PPG signals.
`Dedicated software is used to filter the signals and compute
`SpO2 and HR based on the relative amplitude and frequency
`content of the reflected PPG signals. A tri-axis MEMS
`accelerometer detects changes in body activity, and the
`information obtained through the tilt sensing property of the
`accelerometer is used to determine the orientation of the
`person wearing the device.
`To
`facilitate bi-directional wireless communications
`between the Receiver Module and a PDA, we used the
`DPAC Airborne™ LAN node module (DPAC Technologies,
`Garden Grove, CA). The DPAC module operates at a
`frequency of 2.4GHz, is 802.11b wireless compliant, and has
`a relatively small (1.6 × 1.17 × 0.46 inches) footprint. The
`wireless module runs off a 3.7VDC and includes a built-in
`
`Fig. 1. (Top) Attachment of Sensor Module to the skin; (Bottom)
`photograph of the Receiver Module (left) and Sensor Module (right).
`consists of three units: A Sensor Module, consisting of the
`optical transducer, a stack of round PCBs, and a coin-cell
`battery. The information acquired by the Sensor Module is
`transmitted wirelessly via an RF link over a short range to a
`body-worn Receiver Module. The data processed by the
`Receiver Module can be transmitted wirelessly to a PDA.
`The PDA can monitor multiple wearable pulse oximeters
`simultaneously and allows medics
`to collect vital
`physiological information to enhance their ability to extend
`more effective care to those with the most urgent needs. The
`
`Authorized licensed use limited to: IEEE Staff. Downloaded on April 30,2021 at 16:26:29 UTC from IEEE Xplore. Restrictions apply.
`
`913
`
`8
`
`

`

`TCP/IP stack, a radio, a base-band processor, an application
`processor, and software for a “drop-in” WiFi application. It
`has the advantage of being a plug-and-play device that does
`not require any programming and can connect with other
`devices through a standard UART.
`PDA: The PDA was selected based on size, weight, and
`power consumption. Furthermore, the ability to carry the
`user interface with the medic also allows for greater
`flexibility during deployment. We chose the HP iPAQ h4150
`PDA because it can support both 802.11b and Bluetooth™
`wireless communication. It contains a modest amount of
`storage and has sufficient computational resources for the
`intended application. The use of a PDA as a local terminal
`also provides a low-cost touch screen interface. The user-
`friendly
`touch screen of
`the PDA offers additional
`flexibility. It enables multiple controls to occupy the same
`physical space and the controls appear only when needed.
`Additionally, a touch screen reduces development cost and
`time, because no external hardware is required. The data
`from the wireless-enabled PDA can also be downloaded or
`streamed to a remote base station via Bluetooth or other
`wireless communication protocols. The PDA can also serve
`to temporarily store vital medical information received from
`the wearable unit.
`A dedicated National Instruments LabVIEW program was
`developed to control all interactions between the PDA and
`the wearable unit via a graphical user interface (GUI). One
`part of the LabVIEW software is used to control the flow of
`information through the 802.11b radio system on the PDA.
`A number of LabVIEW VIs programs are used to establish a
`connection, exchange data, and close
`the connection
`between the wearable pulse oximeter and the PDA. The
`LabVIEW program interacts with the Windows CE™
`drivers of the PDA’s wireless system. The PDA has special
`drivers provided by the manufacturer that are used by
`Windows CE™
`to
`interface with
`the 802.11b radio
`hardware. The LabVIEW program interacts with Windows
`CE™ on a higher level and allows Windows CE™ to handle
`the drivers and the direct control of the radio hardware.
`The user interacts with the wearable system using a
`simple GUI, as depicted in Fig. 3.
`
`Fig. 3. Sample PDA Graphical User Interface (GUI).
`The GUI was configured to present the input and output
`information to the user and allows easy activation of various
`
`functions. In cases of multiple wearable devices, it also
`allows the user to select which individual to monitor prior to
`initiating the wireless connection. Once a specific wearable
`unit is selected, the user connects to the remote device via
`the System Control panel that manages the connection and
`sensor control buttons. The GUI also displays the subject’s
`vital signs, activity level, body orientation, and a scrollable
`PPG waveform that is transmitted by the wearable device.
`The stream of data received from the wearable unit is
`distributed to various locations on the PDA’s graphical
`display. The most prominent portion of the GUI display is
`the scrolling PPG waveform, shown in Fig. 3. Numerical
`SpO2 and HR values are displayed is separate indicator
`windows. A separate tri-color indicator is used to annotate
`the subject’s activity level measured by the wearable
`accelerometer. This activity level was color coded using
`green, yellow, or red to indicate low or no activity, moderate
`activity, or high activity, respectively. In addition, the
`subject’s orientation is represented by a blue indicator that
`changes orientation according to body posture. Alarm limits
`could be set to give off a warning sign if the physiological
`information exceeds preset safety limits.
`One of the unique features of this PDA-based wireless
`system architecture is the flexibility to operate in a free
`roaming mode. In this ad-hoc configuration, the system’s
`integrity depends only on the distance between each node.
`This allows the PDA to communicate with a remote unit that
`is beyond the PDA’s wireless range. The ad-hoc network
`would
`therefore allow medical personnel
`to quickly
`distribute sensors
`to multiple causalities and begin
`immediate triage, thereby substantially simplifying and
`reducing deployment time.
`Power Management: Several features were incorporated
`into the design in order to minimize the power consumption
`of the wearable system. The most stringent consideration
`was the total operating power required by the Sensor
`Module, which has to drive the R and IR LEDs, process the
`data, and transmit this information wirelessly to the Receive
`Module. To keep the overall size of the Sensor Module as
`small as, it was designed to run on a watch style coin-cell
`battery.
` It should be noted that low power management without
`compromising signal quality is an essential requirement in
`optimizing
`the design of wearable pulse oximeter.
`Commercially available transducers used with transmission
`and reflection pulse oximeters employ high brightness LEDs
`and a small PD element, typically with an active area
`ranging between 12 to 15mm2. One approach to lowering the
`power consumption of a wireless pulse oximeter, which is
`dominated by the current required to drive the LEDs, is to
`reduce the LED duty cycle. Alternatively, minimizing the
`drive currents supplied to the R and IR LEDs can also
`achieve a significant reduction in power consumption.
`However, with reduced current drive, there can be a direct
`impact on the quality of the detected PPGs. Furthermore,
`since most of the light emitted from the LEDs is diffused by
`the skin and subcutaneous tissues, in a predominantly
`forward-scattering direction, only a small fraction of the
`incident light is normally backscattered from the skin. In
`
`Authorized licensed use limited to: IEEE Staff. Downloaded on April 30,2021 at 16:26:29 UTC from IEEE Xplore. Restrictions apply.
`
`914
`
`9
`
`

`

`addition, the backscattered light intensity is distributed over
`a region that is concentric with respect to the LEDs.
`Consequently, the performance of reflectance pulse oximetry
`using a small PD area is significantly degraded. To
`overcome this limitation, we showed that a concentric array
`of either discrete PDs, or an annularly-shaped PD ring, could
`be used to increase the amount of backscattered light
`detected by a reflectance type pulse oximeter sensor [5]-[7].
`Besides a low-power consuming sensor, afforded by
`lowering the driving currents of the LEDs, a low duty cycle
`was employed to achieve a balance between low power
`consumption and adequate performance. In the event that
`continuous monitoring is not required, more power can be
`conserved by placing the device in an ultra low-power
`standby mode. In this mode, the radio is normally turned off
`and is only enabled for a periodic beacon to maintain
`network association. Moreover, a decision to activate the
`wearable pulse oximeter can be made automatically in the
`event of a patient alarm, or based on the activity level and
`posture
`information
`derived
`from
`the
`on-board
`accelerometer. The wireless pulse oximeter can also be
`activated or deactivated remotely by a medic as needed,
`thereby further minimizing power consumption.
`
`III. IN VIVO EVALUATIONS
`Initial laboratory evaluations of the wearable pulse
`oximeter
`included
`simultaneous HR
`and
`SpO2
`measurements. The Sensor Module was positioned on the
`forehead using an elastic headband. Baseline recordings
`were made while the subject was resting comfortably and
`breathing at a normal tidal rate. Two intermittent recordings
`were also acquired while the subject held his breath for
`about 30 seconds. Fig. 4 displays about 4 minutes of SpO2
`and HR recordings acquired simultaneously by the sensor.
`
`Fig. 4. Typical HR (solid line) and SpO2 (dashed line) recording of two
`voluntary hypoxic episodes.
`The pronounced drops in SpO2 and corresponding increases
`in HR values coincide with the hypoxic events associated
`with the two breath holding episodes.
`
`IV. DISCUSSION
`The emerging development of compact, low power, small
`size, light weight, and unobtrusive wearable devices can
`facilitate
`remote
`noninvasive monitoring
`of
`vital
`
`physiological signs. Wireless physiological information can
`be useful to monitor soldiers during training exercises and
`combat missions, and help emergency first-responders
`operating in harsh and hazardous environments. Similarly,
`wearable physiological devices could become critical in
`helping to save lives following a civilian mass casualty. The
`primary goal of such a wireless mobile platform would be to
`keep track of an injured person’s vital signs via a short-range
`wirelessly-linked personal area network,
`thus readily
`allowing RF telemetry of vital physiological information to
`command units and remote off-site base stations for
`continuous real-time monitoring by medical experts.
`The preliminary bench testing plotted in Fig. 4 showed
`that the SpO2 and HR readings are within an acceptable
`clinical range. Similarly, the transient changes measured
`during the two breath holding maneuvers confirmed that the
`response time of the custom pulse oximeter is adequate for
`detecting hypoxic episodes.
`
`V. CONCLUSION
`A wireless, wearable, reflectance pulse oximeter has been
`developed based on a small forehead-mounted sensor. The
`battery-operated device employs a
`lightweight optical
`reflectance sensor and incorporates an annular photodetector
`to reduce power consumption. The system has short range
`wireless communication capabilities to transfer SpO2, HR,
`body acceleration, and posture information to a PDA carried
`by medics or first responders. The information could
`enhance the ability of first responders to extend more
`effective medical care, thereby saving the lives of critically
`injured persons.
`
`ACKNOWLEDGMENT
`The authors would like to acknowledge the financial support
`provided by the U.S. Army Medical Research and Material
`Command referenced.
`
`REFERENCES
`[1] G. S. F. Ling, B. K. Day, P. Rhee, and J. M. Ecklund, “In search of
`to battlefield management of combat
`technological solutions
`casualties,” SPIE Conference on Battlefield Biomedical Technologies,
`SPIE vol. 3712, Apr. 1999.
`[2] D. Malan, T. Fulford-Jones, M. Welsh, and S. Moulton, “CodeBlue:
`An ad-hoc sensor network infrastructure for emergency medical care,”
`International Workshop on Wearable and Implantable Body Sensor
`Networks, 2004.
`[3] U. Anliker et al., “AMON: A wearable multiparameter medical
`monitoring and alert system,” IEEE Trans. on Information Technology
`in Biomedicine, 8(4), 2004.
`[4] Y. Mendelson and V. Floroff, “A PDA based ad-hoc mobile wireless
`pulse oximeter,” Proc. IASTED International Conference Telehealth
`2005, Banff, Canada, 2005.
`[5] Y. Mendelson and C. J. Pujary, “Minimization of LED power
`consumption in the design of a wearable pulse oximeter,” IASTED
`International Conference BioMED 2003, Salzburg, Austria, 2003.
`[6] Y. Mendelson and C. J. Pujary, “Measurement site and photodetector
`size considerations in optimizing power consumption of a wearable
`reflectance pulse oximeter,” Proc. of the 25th Annual International
`IEEE/EMBS Conference, Cancun, Mexico, 2003.
`[7] P. Branche and Y. Mendelson, “Signal quality and power
`consumption of a new prototype reflectance pulse oximeter sensor,”
`Proc. of the 31th Annual Northeast Bioengineering Conference,
`Hoboken, NJ, 2005.
`
`Authorized licensed use limited to: IEEE Staff. Downloaded on April 30,2021 at 16:26:29 UTC from IEEE Xplore. Restrictions apply.
`
`915
`
`10
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket