IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Jeroen Poeze et al.
`In re Patent of:
`10,912,501 Attorney Docket No.: 50095-0042IP2
`U.S. Patent No.:
`February 9, 2021
`Issue Date:
`Appl. Serial No.: 17/031,356
`Filing Date:
`September 24, 2020
`Title:
`USER-WORN DEVICE FOR NONINVASIVELY MEASURING
`A PHYSIOLOGICAL PARAMETER OF A USER
`
`DECLARATION OF JUNE ANN MUNFORD
`
`1
`
`APPLE 1028
`
`

`

`1. My name is June Ann Munford. I am over the age of 18, have personal
`
`knowledge of the facts set forth herein, and am competent to testify to the
`
`same.
`
`2. I earned a Master of Library and Information Science (MLIS) from the
`
`University of Wisconsin-Milwaukee in 2009. I have over ten years of
`
`experience in the library/information science field. Beginning in 2004, I
`
`have served in various positions in the public library sector including
`
`Assistant Librarian, Youth Services Librarian and Library Director. I have
`
`attached my Curriculum Vitae as Appendix CV.
`
`3. During my career in the library profession, I have been responsible for
`
`materials acquisition for multiple libraries. In that position, I have cataloged,
`
`purchased and processed incoming library works. That includes purchasing
`
`materials directly from vendors, recording publishing data from the material
`
`in question, creating detailed material records for library catalogs and
`
`physically preparing that material for circulation. In addition to my
`
`experience in acquisitions, I was also responsible for analyzing large
`
`collections of library materials, tailoring library records for optimal catalog
`
`1
`
`
`
`
`
`
`
`2
`
`

`

`search performance and creating lending agreements between libraries
`
`during my time as a Library Director.
`
`
`4. I am fully familiar with the catalog record creation process in the library
`
`sector. In preparing a material for public availability, a library catalog record
`
`describing that material would be created. These records are typically
`
`written in Machine Readable Catalog (herein referred to as “MARC”) code
`
`and contain information such as a physical description of the material,
`
`metadata from the material’s publisher, and date of library acquisition. In
`
`particular, the 008 field of the MARC record is reserved for denoting the
`
`date of creation of the library record itself. As this typically occurs during
`
`the process of preparing materials for public access, it is my experience that
`
`an item’s MARC record indicates the date of an item’s public availability.
`
`
`5. Typically, in creating a MARC record, a librarian would gather various bits
`
`of metadata such as book title, publisher and subject headings among others
`
`and assign each value to a relevant numerical field. For example, a book’s
`
`physical description is tracked in field 300 while title/attribution is tracked in
`
`field 245. The 008 field of the MARC record is reserved for denoting the
`
`creation of the library record itself. As this is the only date reflecting the
`
`inclusion of said materials within the library’s collection, it is my experience
`
`
`
`2
`
`3
`
`

`

`that an item’s 008 field accurately indicates the date of an item’s public
`
`availability.
`
`
`6. I have reviewed Exhibit APPLE-1013, Design of Pulse Oximeters edited by
`
`J.D. Webster.
`
`
`7. Attached hereto as Appendix WEBSTER01 is a true and correct copy of the
`
`MARC record for Design of Pulse Oximeters as held by the Penn State
`
`University library. I secured this record myself from the library’s public
`
`catalog. The MARC record contained within Appendix WEBSTER01
`
`accurately describes the title, author, publisher, and ISBN number of Design
`
`of Pulse Oximeters.
`
`
`8. Attached hereto as Appendix WEBSTER02 is a true and correct copy of
`
`scans of select pages from Design of Pulse Oximeters as held by the Penn
`
`State University library. I secured these scans myself from the library’s
`
`collection. For the purposes of this declaration, these scans do not show the
`
`entire textbook, but only select pages of the textbook. In comparing Exhibit
`
`APPLE-1013 to the textbook from which I obtained the partial scans of
`
`Appendix WEBSTER02, it is my determination that Exhibit APPLE-1013 is
`
`
`
`3
`
`4
`
`

`

`a true and correct copy of Design of Pulse Oximeters, edited by J.D.
`
`Webster.
`
`
`9. The 008 field of the MARC record in Appendix WEBSTER01 indicates the
`
`date of record creation. The 008 field of Appendix WEBSTER01 indicates
`
`Penn State University library first acquired this book as of November 23,
`
`1997. Considering this information, it is my determination that Design of
`
`Pulse Oximeters was made available to the public shortly after its initial
`
`acquisition in November 23, 1997.
`
`
`10. I have been retained on behalf of the Petitioner to provide assistance in the
`
`above-illustrated matter in establishing the authenticity and public
`
`availability of the documents discussed in this declaration. I am being
`
`compensated for my services in this matter at the rate of $100.00 per hour
`
`plus reasonable expenses. My statements are objective, and my
`
`compensation does not depend on the outcome of this matter.
`
`
`11. I declare under penalty of perjury that the foregoing is true and correct. 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 the knowledge that
`
`
`
`4
`
`5
`
`

`

`willful false statements and the like so made are punishable by fine or
`
`imprisonment, or both, under Section 1001 of Title 18 of the United States
`
`Code.
`
`
`
`
`
`
`Dated: 7/14/2022
`
`
`
`June Ann Munford
`
`
`
`5
`
`6
`
`

`

`APPENDIX CV
`APPENDIX CV
`
`7
`
`

`

`J. Munford
`Curriculum Vitae
`
`Education
`
`University of Wisconsin-Milwaukee - MS, Library & Information Science, 2009
`Milwaukee, WI
`
`
`● Coursework included cataloging, metadata, data analysis, library systems,
`management strategies and collection development.
`● Specialized in library advocacy, cataloging and public administration.
`
`
`Grand Valley State University - BA, English Language & Literature, 2008
`Allendale, MI
`
` ●
`
` Coursework included linguistics, documentation and literary analysis.
`● Minor in political science with a focus in local-level economics and
`government.
`
`
`
`Professional Experience
`
`Researcher / Expert Witness, October 2017 – present
`Freelance ● Pittsburgh, Pennsylvania & Grand Rapids, Michigan
`
`
`● Material authentication and public accessibility determination.
`Declarations of authenticity and/or public accessibility provided upon
`research completion. Experienced with appeals and deposition process.
`
` ●
`
` Research provided on topics of public library operations, material
`publication history, digital database services and legacy web resources.
`
` ●
`
` Past clients include Alston & Bird, Arnold & Porter, Baker Botts, Fish &
`Richardson, Erise IP, Irell & Manella, O'Melveny & Myers, Perkins-Coie,
`Pillsbury Winthrop Shaw Pittman and Slayden Grubert Beard.
`
`Library Director, February 2013 - March 2015
`Dowagiac District Library ● Dowagiac, Michigan
`
`
`● Executive administrator of the Dowagiac District Library. Located in
`
`8
`
`

`

`Southwest Michigan, this library has a service area of 13,000, an annual
`operating budget of over $400,000 and total assets of approximately
`$1,300,000.
`
`● Developed careful budgeting guidelines to produce a 15% surplus during
`the 2013-2014 & 2014-2015 fiscal years while being audited.
`
`
`
` ●
`
` Using this budget surplus, oversaw significant library investments
`including the purchase of property for a future building site, demolition of
`existing buildings and building renovation projects on the current facility.
`
` Led the organization and digitization of the library's archival records.
`
` ●
`
` ●
`
` Served as the public representative for the library, developing business
`relationships with local school, museum and tribal government entities.
`
` ●
`
` Developed an objective-based analysis system for measuring library
`services - including a full collection analysis of the library's 50,000+
`circulating items and their records.
`
`November 2010 - January 2013
`Librarian & Branch Manager, Anchorage Public Library ● Anchorage, Alaska
`
`
`● Headed the 2013 Anchorage Reads community reading campaign
`including event planning, staging public performances and creating
`marketing materials for mass distribution.
`
` ●
`
` Co-led the social media department of the library's marketing team,
`drafting social media guidelines, creating original content and instituting
`long-term planning via content calendars.
`
` ●
`
` Developed business relationships with The Boys & Girls Club, Anchorage
`School District and the US Army to establish summer reading programs for
`children.
`
`
`June 2004 - September 2005, September 2006 - October 2013
`Library Assistant, Hart Area Public Library
`Hart, MI
`
`
`● Responsible for verifying imported MARC records and original MARC
`
`9
`
`

`

`
`
`cataloging for the local-level collection as well as the Michigan Electronic
`Library.
`
`● Handled OCLC Worldcat interlibrary loan requests & fulfillment via
`ongoing communication with lending libraries.
`
`
`
`Professional Involvement
`
`Alaska Library Association - Anchorage Chapter
`● Treasurer, 2012
`
`
`Library Of Michigan
`● Level VII Certification, 2008
`● Level II Certification, 2013
`
`
`Michigan Library Association Annual Conference 2014
`● New Directors Conference Panel Member
`
`
`Southwest Michigan Library Cooperative
`● Represented the Dowagiac District Library, 2013-2015
`
`
`
`Professional Development
`
`Library Of Michigan Beginning Workshop, May 2008
`Petoskey, MI
`● Received training in cataloging, local history, collection management,
`children’s literacy and reference service.
`
`
`Public Library Association Intensive Library Management Training, October 2011
`Nashville, TN
`● Attended a five-day workshop focused on strategic planning, staff
`management, statistical analysis, collections and cataloging theory.
`
`
`Alaska Library Association Annual Conference 2012 - Fairbanks, February 2012
`Fairbanks, AK
`● Attended seminars on EBSCO advanced search methods, budgeting,
`cataloging, database usage and marketing.
`
`10
`
`

`

`Depositions
`
`2019 ● Fish & Richardson
`
`IPR Petitions of 865 Patent, Apple v. Qualcomm (IPR2018-001281 /
`
`39521-00421IP & IPR2018-01282 / 39521-00421IP2)
`
`2019 ● Erise IP
`
`Implicit, LLC v. Netscout Systems, Inc (Civil Action No. 2:18-cv-53-JRG)
`
`2019 ● Perkins-Coie
`
`Adobe Inc. v. RAH Color Technologies LLC (Cases IPR2019-00627,
`
`IPR2019-00628, IPR2019-00629 and IPR2019-00646)
`
`2020 ● O’Melveny & Myers
`
`Maxell, Ltd. v. Apple Inc. (Case 5:19-cv-00036-RWS)
`
`2021 ● Pillsbury Winthrop Shaw Pittman LLP
`
`Intel v. SRC (Case IPR2020-1449)
`
`
`Limited Case History & Potential Conflicts
`
`Alston & Bird
`
`● Nokia (v. Neptune Subsea, Xtera)
`
`Arnold & Porter
`
`● Ivantis (v. Glaukos)
`
`Erise I.P.
`
`● Apple
`
`
`v. Future Link Systems (IPRs 6317804, 6622108, 6807505, and
`
`
`7917680)
`
`
`v. INVT
`
`
`v. Navblazer LLC (Case No. IPR2020-01253)
`
`11
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`v. Qualcomm (IPR2018-001281, 39521-00421IP, IPR2018-01282,
`39521-00421IP2)
`v. Quest Nettech Corp, Wynn Technologies (Case No. IPR2019-
`00XXX, RE. Patent Re38137)
`
`● Fanduel (v CGT)
`
`● Garmin (v. Phillips North America LLC, Case No. 2:19-cv-6301-AB-KS
`Central District of California)
`
`● Netscout
`
`v. Longhorn HD LLC)
`
`v. Implicit, LLC (Civil Action No. 2:18-cv-53-JRG)
` ● Sony Interactive Entertainment LLC
`v. Bot M8 LLC
`v. Infernal Technology LLC
`● Unified Patents (v GE Video Compression, Civil Action No. 2:19-cv-248)
`
`
`Fish & Richardson
`
`● Apple
`
`
`v. LBS Innovations
`
`
`v. Masimo (IPR 50095-0012IP1, 50095-0012IP2, 50095-0013IP1,
`
`
`50095-0013IP2, 50095-0006IP1)
`
`
`v. Neonode
`
`
`v. Qualcomm (IPR2018-001281, 39521-00421IP, IPR2018-01282,
`
`
`39521-00421IP2)
`
`
`
`
`● Dish Network
`
`v. Realtime Adaptive Streaming, Case No 1:17-CV-02097-RBJ)
`
`12
`
`

`

`v. TQ Delta LLC
`
` Huawei (IPR 76933211)
`
` Kianxis
`
`
`
` ●
`
` ●
`
` ●
`
` LG Electronics (v. Bell Northern Research LLC, Case No. 3:18-cv-2864-
`CAB-BLM)
`
` ●
`
` ●
`
` Samsung (v. Bell Northern Research, Civil Action No. 2:19-cv-00286-
`JRG)
`
` Texas Instruments
`
` ●
`
`
`Irell & Manella
`
`● Curium
`
`O’Melveny & Myers
`
`● Apple (v. Maxell, Case 5:19-cv-00036-RWS)
`
`Perkins-Coie
`
`● TCL Industries (v. Koninklijke Philips NV, PTAB Case Nos. IPR2021-
`
`00495, IPR2021-00496, and IPR2021-00497)
`
`Pillsbury Winthrop Shaw Pittman
`
`● Intel (v. FG SRC LLC, Case No. 6:20-cv-00315 W.D. Tex)
`
` Metaswitch
`
` MLC Intellectual Property (v. MicronTech, Case No. 3:14-cv-03657-SI)
`
` Realtek Semiconductor
`
` Quectel
`
` ●
`
` ●
`
` ●
`
`13
`
`

`

`APPENDIX WEBSTER 01
`APPENDIX WEBSTER01
`
`14
`
`

`

`UniversityLibraries Catalog
`
`PennState
`
`Keyword
`
`=
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`Search...
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`screenshot-catalog.libraries.psu.edu-2022.06.13-07_44_23
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`
`MARC View
`
`LEADER 01206nam 422003258a 4500
`
`001 1441469
`
`003 SIRSI
`
`
`
`ASK ®,
`005 20151215023516.0
`008 971126t19971997xxk b 000 0 eng d
`FMTRN
`010
`a| 97037908
`
`019
`a| MARS
`
`020
`a| 0750304677 (alk. paper)
`
`035
`a| LIAS2049620
`
`035
`a| (OCOLC)37553776
`
`040
`c] PStd| WaOLN d| UtOrBLWw
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`QO a| OP9S.3.09 5] Da? 1997
`
`245 0
`QO a| Design of pulse oximeters /¢| edited by |.G. Webster.
`
`264
`1
`a| Bristol; a| Philadelphia: b| Institute of Physics Pub., c| [1997]
`
`264
`4 c| ©1997
`
`300
`a| xvi, 244 pages: b| illustrations ;¢| 24 cm.
`
`336
`a|
`text b| txt 2| rdacontent
`
`337
`a| unmediated b| n2| rdamedia
`
`338
`a| volume b| ne 2| rdacarrier
`
`490 1
`a| Medical science series
`
`504
`a|
`Includes bibliographical references and index.
`
`650
`0 a| Pulse oximeters x| Design and construction.
`
`7O0O
`1
`a| Webster, John G., d| 1932-
`
`830
`0 a| Medical science series,
`
`949
`a| QPS9.3.09D47 1997 w| LC c| 1i| 000032305944 d| 7/27/2021 e| 5/5/2021 1| PATERNO-4 m| UP-PATn| 15r] ¥s| ¥t| BOOK u|
`
`4/13/2001
`
`a| QP99,3.09D47 1997 w| LC ¢| 11] 000032031126 d| 10/14/2015 e| 6/29/2015 || STACKS-WB m| WILKESBAR n| 2r| ¥s| ¥¢|
`949
`BOOKFLOATu| 4/13/2001
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`13.06.2022
`
`Design of pulse oximeters / edited by J.G. Webster
`DESIGN
`l]ages
`OXIMETERS
`Bristol ; Philadelphia:Institute of Physics Pub., [1997]
`
`Published: Copyright Date:
`
`xvi, 244 pages:
`Physical Description:
`al
`4 oe)
`Webster, John G,, 1932-
`— Additional Creators:
`Se)
`(emerey
`
`FMe earth
`
`©1997
`
`illustrations ; 24 cm,
`
`Availability
`
`Penn State Wilkes-Barre (1 item)
`Call number
`
`QP9S9.3.09D47 1997
`
`Material
`
`Book
`
`Location
`
`Stacks - General C
`
`ollection
`
`Pattee Library and Paterno Library Stacks(1 item)
`Call number
`
`QP99.3,.09D47 1997
`
`Material
`
`Book
`
`Location
`
`Paterno - 4th Floor
`
`WD faircealea
`
`te
`
`Series:
`
`Medical science series
`
`Subject(s):
`Pulse oximeters—Design and construction
`
`ISBN:
`
`0750304677 (alk. paper)
`
`Bibliography Note:
`Includes bibliographical references and index.
`
`poh RyPM
`connect with|ASK 2,
`PennState
`@
`Paeres
`Rivaseeahry:|jun ssualu
`
`POMSIRetis)
`
`View MARC record | catkey: 1441469
`
`16
`
`16
`
`

`

`APPENDIX WEBSTER 02
`APPENDIX WEBSTER02
`
`17
`
`

`

`
`
`DESIGN
`OF PULSE
`
`OXIMETERS
`
`
`
`|e
`
`
`
`
`
`18
`
`

`

`(—} —|
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`19
`
`

`

`Series Editors
`
`R F Mould, Scientific Consultant, Croydon, UK
`CG Orton, Karamanos Cancer Institute, Detroit, USA
`JAE Spaan, University of Amsterdam, The Netherlands
`JG Webster, University of Wisconsin-Madison, USA
`
`The Medical Science Series books describe the applications of physical
`leeeee Metter Tit Myce)[eyCML te) ty
`are written for graduate students and researchersin manydisciplines including
`medicalphysics, biomedical engineering, radiology, radiotherapy andclinical
`research.
`
`The Medical ScienceSeries is the official book series of the International
`Organization for Medical Physics and the International Federation for Medical
`and Biological Engineering.
`
`Pulse oximetry provides early information on problemsin the delivery of oxygen to
`tissue. Recognized worldwide as the standard of care in anesthesiology,itis used
`in diverse applications from hospital intensive care units to veterinary surgeries.
`
`Design Of Pulse Oximeters is a unique handbook which describes the hardware
`and software needed to make a pulse oximeter, and includes the equations,
`methods,and software requiredfor them to functioneffectively.It is written for
`biomedical engineers, medicalphysicists, and health care providers and organized
`so that a nonbiomedical engineer can learn enough about oximetry to understand
`the design information.
`
`
`
`The book begins with a brief discussion on how oxygenis delivered to the tissue
`and discusses the problems and diseasesthat can occur.It relates the background
`to the pulse oximeter, including historical oxygenation measurement, and the
`CO-oximeter ‘gold standard’.
`Most Wieameielcest eis
`e full technical descriptions for hemoglobin oxygen saturation display and
`light-emitting diode operation;
`@ asurveyof the different types of light sensor, with particular
`emphasis on the single photodiode;
`@ areview of the design of reusable and disposable probes and cables;
`e hardware descriptions, including signal amplification and calculation
`of oxygen saturation;
`@ worked examplesof flow charts and algorithms for oxygen
`saturation calculations;
`@ anassessment of different techniques used to evaluate
`pulse oximeter performance;
`@ a brief overview of pulse oximetry applications.
`Additional features include a glossary of terms, instructional objective summaries
`by chapter, and a useful reference list to direct the reader to sourcesfor further
`reading.
`John G Websterleads a world-ranking research team at the University of
`Wisconsin-Madison. Its research interests include: electrode designfor cardiac
`catheter radio-frequencyablation; sensors for measurementof human vigilance;
`sensor-based control systems for anesthesia machines; methods for minimizing
`electrocardiograph interference; and ventilation monitors for adults and neonates.
`The contributors haveall been part of John Webster's teaching or research program.
`
`ISBN 0-7503-0467-7
`ALM 2a) eea
`ATE UNIVERSITY LIBRAR'
`
`wmv
`
`AQGGOG3eO0311cb
`
`oLIMl IMM | HI
`0°304672">
`
`Sackedteen atlsicatiys
`Bristol and Philadelphia
`
`20
`
`

`

`
`
`PENNSTATE
`
`UNIVERSITY
`
`LIBRARIES
`
`~
`
`|
`
`Ba
`
`21
`
`

`

`
`
`Design of Pulse Oximeters
`
`22
`
`22
`
`

`

`Medical Science Series
`
`Design of Pulse Oximeters
`
`Edited by
`
`J G Webster
`
`Departmentof Electrical and Computer Engineering
`University of Wisconsin-Madison
`
`Institute of Physics Publishing
`Bristol and Philadelphia
`
`THE PENNSYLVANIA STATE UNIVERSITY
`COMMONWEALTH CAMPUS LIBRARIES
`WILKES-BARRE
`
`
`23
`
`

`

`
`
`© IOP Publishing Ltd 1997
`
`All rights reserved. No part of this publication may be reproduced, stored in a
`retrieval system or
`transmitted in any form or by any means, electronic,
`mechanical, photocopying, recording or otherwise, without the prior permission
`of the publisher. Multiple copying is permitted in accordance with the terms of
`licences issued by the Copyright Licensing Agency under
`the terms of its
`agreement with the Committee of Vice-Chancellors and Principals.
`
`British Library Cataloguing-in-Publication Data
`
`A catalogue record for this bookis available from the British Library.
`
`ISBN 0 7503 0467 7
`
`Library of Congress Cataloging-in-Publication Data are available
`
`the figures and
`The Editor has attempted to trace the copyright holder of all
`tables reproduced in this publication and apologizes to copyright holders if
`permission to publish in this form has not been obtained.
`
`Series Editors:
`R F Mould, Croydon, UK
`C G Orton, Karamanos CancerInstitute, Detroit, USA
`J AE Spaan, University of Amsterdam, The Netherlands
`J G Webster, University of Wisconsin-Madison, USA
`
`Published by Institute of Physics Publishing, wholly owned by The Institute of
`Physics, London
`
`Institute of Physics Publishing, Dirac House, Temple Back, Bristol BS1 6BE, UK
`
`US Editorial Office: Institute of Physics Publishing, The Public Ledger Building,
`Suite 1035, 150 South Independence Mall West, Philadelphia, PA 19106, USA
`
`Prepared by the Editor using Microsoft Word 6
`
`Printed in Great Britain by J W Arrowsmith Ltd, Bristol
`
`24
`
`24
`
`

`

`
`
`CONTENTS
`
`
`PREFACE
`
`l
`
`NORMAL OXYGEN TRANSPORT
`Susanne A Clark
`
`1.1
`
`1.2
`
`Ls
`
`— atA
`
`1.7
`
`1.8
`
`Ventilatory control
`1.1.1
`Neural control
`1.1.2
`Respiratory feedback
`Ventilatory mechanics
`1.2.2.
`Expiration
`Diffusion to blood
`1.3.1
`The alveoli
`1.3.2
`Gas exchange
`Bind to hemoglobin
`1.4.1.
`Characteristics of hemoglobin
`1.4.2
`Oxyhemoglobin dissociation curves
`Dissolved in plasma
`Circulation
`1.6.1
`The heart
`1.6.2.
`Pulmonary circulation
`1.6.3.
`Systemic circulation
`1.6.4
`Cardiac output
`Diffusionto tissue
`1.7.1.
`Diffusion into interstitial fluid and cell
`1.7.2
`Oxygen delivered
`1.7.3. Myoglobin
`Usein cell
`References
`Instructional objectives
`
`MOTIVATION OF PULSE OXIMETRY
`Daniel J Sebald
`
`2.1 Pulse oximeterprinciples
`2.2.1
`Comprehensive approach
`2.2.2
`Arterial oxygen saturation
`2.2.3.
`Hypoxia and hypoxemia
`2.2.4
`Role of SpO2 in avoiding hypoxia
`
`25
`
`XV
`
`
`
`OwWWwOwOWOOCOWNAANNUANNNR
`
`—_
`
`13
`15
`15
`15
`16
`
`
`
`25
`
`

`

`
`
`Vill
`
`Contents
`
`2.3
`
`Photoplethysmography
`2.2.5
`Hyperoxia
`2.2.6
`Limitations
`2231
`Instrument and operation limitations
`2.3.1
`Limitations in SpO02
`References
`Instructional objectives
`
`BLOOD OXYGEN MEASUREMENT
`James Farmer
`
`3.1
`
`weusatbo
`
`3.4
`
`3.5.
`
`3.6
`3.7
`
`Chemical methods
`3.1.1
`Yan Slyke method
`3.1.2. Mixing syringe method
`3.1.3.
`The Clark electrode
`3.1.4
`The galvanic electrode
`Transcutaneous PO? sensor
`In vitro oximeters
`3.3.1
`Spectrophotometers
`3.3.2.
`The CO-oximeter
`In vivo two-wavelength oximeters
`3.4.1
`The first in vive oximeters
`3.4.2.
`The cyclops
`Fiber optic oximeters
`3.5.1
`In vitro reflectance oximeter
`3.5.2
`In vivo reflectance catheter oximeter
`3.5.3.
`In vivo chemical oximeter
`In vivo eight-wavelength oximeter
`Pulse oximeters
`3.7.1
`Overview
`3.7.2.
`LEDs
`3.7.3
`Photodiode
`3.7.4
`Probes
`B25
`Analog amplifier and signal processing
`3.7.6
`A three-wavelength pulse oximeter for
`COHb determination
`Comparison of pulse oximetry to
`transcutaneous PO? electrodes
`References
`Instructional objectives
`
`3.7.7.
`
`LIGHT ABSORBANCEIN PULSE OXIMETRY
`Oliver Wieben
`
`18
`10
`19
`19
`19
`
`20
`
`21
`
`21
`22
`23
`23
`25
`25
`26
`26
`28
`30
`30
`30
`30
`30
`31
`32
`32
`34
`34
`35
`36
`36
`37
`
`37
`
`38
`38
`39
`
`40
`
`Beer's Law
`4.1
`40
`4.1.1|Transmittance and absorbanceoflight
`4]
`4.1.2 Multiple absorbers
`41
`
`
`
`26
`
`

`

`Contents
`
`1X
`
`4.2
`
`4.3
`
`Hemoglobin extinction coefficients
`4.2.1.
`Functional hemoglobins
`4.2.2
`Dysfunctional hemoglobins
`4.2.3
`Hemoglobin absorbance spectra
`Beer's law in pulse oximetry
`4.3.1
`Criteria for the choice of wavelengths
`4.3.2
`Absorbance in hemoglobin solutions
`4.3.3
`Pulsation of the blood
`4.3.4 Measurementof pulse oximeters
`4.4
`Saturation versus normalized ratio
`4.4.1|Normalization
`4.4.2
`Ratio of normalized signals
`4.4.3
`Theoretic calibration curve
`Validity of Beer's law in pulse oximetry
`Light Scattering
`4.6.1
`Light absorbance in whole blood
`4.6.2 Models for light absorbanceincluding scattering
`4.6.3
`Influence of scattering on pulse oximeter readings
`4.6.4
`Calibration curves used for pulse oximeters
`References
`Instructional objectives
`
`LIGHT-EMITTING DIODES AND THEIR CONTROL
`Brad W J Bourgeois
`
`ail
`
`5.2
`
`nnntn—.bo
`
`Gntun ~]Nn
`
`Anintroduction to light-emitting diodes
`5.1.1
`Description, materials, and operation
`5.1.2
`Bandwidth considerations
`Light-emitting diode specifications
`5.2.1
`Forward voltage
`5.2.2
`Forward current
`5.2.3
`Power dissipation
`5.2.4
`Reverse breakdown voltage
`5.2.5
`Reverse current
`5.2.6
`Operating temperature
`5.2.7
`Switching times
`5.2.8
`Beam angle
`5.2.9
`Pulse capability
`Measuring and identifying LED wavelengths
`LED driver circuit
`LEDpeak wavelength shift with temperature
`5.5.1
`p-n junction heating
`5.5.2
`Studies
`5.5.3.
`Two methods to compensate for
`LED temperature changes
`Prevention of burnsin pulse oximetry
`LED packaging
`References
`Instructional objectives
`
`27
`
`
`
`27
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`

`

`Contents
`
`PHOTODETECTORS AND AMPLIFIERS
`Jeffrey S Schowalter
`
`71
`
`fH
`6.1 Photodetection devices
`71
`6.1.1—Photocells
`72
`1.2
`Photodiodes
`76
`1.3.
`Phototransistors
`76
`1.4
`Integrated circuit (IC) sensors
`hotodiode characteristics
`.2.1
`Junction capacitance
`6.2.2.
`Dark current
`6.2.3
`Sensitivity
`6.2.4
`Spectral response
`6.2.5
`Packaging
`Optical Concerns
`6.3.1
`Optical filtering
`6.3.2
`Optical interference
`Amplifiers
`6.4.1
`Standard transimpedance amplifier configuration
`6.4.2
`Differential transimpedance amplifier
`6.4.3
`Zeroing circuit
`6.4.4
`Future trends
`References
`Instructional objectives
`
`6.2
`
`6.3.
`
`6.4
`
`76
`77
`v7
`Te
`77
`
`79
`79
`79
`80
`82
`
`84
`84
`84
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`
`
`
`
`
`PROBES
`Moola Venkata Subba Reddy
`
`7.1
`
`7.2
`
`aba)UAWBW
`
`Transmittance Probes
`7.1.1
`Principle
`7.1.2
`Sensor placement
`Reflectance Probes
`7.2.1
`Principle
`"7.2.2
`Sensor placement
`7.2.3
`Effect of multiple photodiode arrangement
`7.2.4
`Effect of skin temperature
`7.2.5
`Advantages and disadvantages of
`reflectance probes over transmittance probes
`MIR probes
`Probe connectors
`Reusable probes
`Disposable probes
`Sources of errors due to probes and placement
`7.7.1.
`Ambientlight interference
`7.7.2.
`Optical shunt
`7.7.3.
`Edema
`7.7.4.
`Nail Polish
`References
`Instructional objectives
`
`86
`
`86
`87
`87
`88
`88
`90
`
`91
`91
`92
`93
`94
`94
`94
`95
`95
`95
`96
`96
`
`28
`
`28
`
`

`

`ELECTRONIC INSTRUMENT CONTROL
`Ketan S Paranjape
`
`Contents
`
`xi
`
`97
`
`
`
`
`
`97
`General theory of operation
`98
`8.1.1
`Historic perspective
`99
`8.2. Main block diagram
`100
`8.2.1
`Input module
`101
`Digital processor system
`8.3.
`
`8.3.1|Microprocessor subsection 101
`8.3.2
`General block description
`102
`8.3.3 Wait state generator
`103
`8.3.4
`Clock generator, timer circuit and UART
`103
`8.3.5
`Pattern generator
`104
`Analog processing system (Nellcor®)
`105
`8.4.1
`Analog signal flow
`105
`8.4.2
`Coding resistor, temperature sensor, and prefiltering
`105
`8.4.3
`Preamplifier
`105
`8.4.4
`Demodulator andfiltering
`106
`8.4.5
`DCoffset elimination
`107
`8.4.6
`Timing diagram (Nellcor®)
`109
`8.4.7.
`LED driver circuit
`110
`8.4.8
`Analog processing system (Ohmeda®)
`111
`ECGsection
`113
`8.5.1
`Active filters
`114
`8.5.2
`Offset amplifiers
`114
`8.5.3.
`Detached lead indicator
`114
`8.5.4
`Powerline frequency sensing
`115
`8.5.5
`ECG output
`115
`Signal conversion
`116
`8.6.1
`Analog-to-digital conversion technique
`116
`8.6.2
`Digital-to-analog conversion
`117
`8.6.3
`Sample-and-holdcircuit
`117
`Timing and control
`117
`8.7.1
`Polling and interrupt
`117
`Power Supply
`118
`Alarms
`119
`Storage
`119
`Front end display
`120
`8.11.1
`Front end driver circuit
`120
`8.11.2 Front panel contro]
`121
`8.11.3 Power up displaytests
`12]
`Speakers
`121
`References
`122
`Instructional objectives
`122
`
`8.1
`
`8.4
`
`8.5
`
`8.6
`
`8.7
`
`8.8
`8.9
`8.10
`8.11
`
`8.12
`
`SIGNAL PROCESSING ALGORITHMS
`Surekha Palreddy
`
`9.1
`9.2
`
`Sources of errors
`Beer-Lambert law
`
`29
`
`124
`
`124
`125
`
`29
`
`

`

`Xi
`
`Contents
`
`9.2.1
`
`Estimation of oxygen saturation
`using the Beer-Lambert law
`Ratio of ratios
`9.3.1
`Peak and valley method
`9.3.2
`Derivative method: noise reduction software
`General processing steps of oximetry signals
`9.4.1
`Start up software
`Transient conditions
`ECG synchronization algorithms
`9.6.1
` Nellcor® system
`9.6.2
` Criticare® system
`Spectral methodsof estimating SpO2
`References
`Instructional objectives
`
`© a
`
`0nw
`
`DF
`
`10
`
`CALIBRATION
`Jeffrey S Schowalter
`
`10.1
`
`10.2
`
`10.3
`
`Calibration methods
`10.1.1 Traditional in vive calibration
`10.1.2
`Invitro calibration using blood
`Testing simulators
`10.2.1
`Simulators using blood
`10.2.2 Nonblood simulators
`10.2.3 Electronic simulators
`Standards
`10.3.1 ASTM F1415
`10.3.2
`ISO 9919
`10.3.3 Other standards
`References
`Instructional objectives
`
`ACCURACY AND ERRORS
`Supan Tungjitkusolmun
`
`Ed Evaluation of pulse oximeters
`11.1.1 Accuracy, bias, precision, and confidence limit
`11.1.2 What do pulse oximeters really measure?
`11.1.3 Pulse oximeter versus CO-oximeter
`11.1.4 Pulse oximeter versus
`in vivo eight-wavelength ear oximeter
`Accuracy versus saturation
`11.2.1 High saturation (greater than 97.5%)
`11.2.2 Normal saturation (90 to 97.5%)
`11.2.3 Low saturation (less than 90%)
`Accuracy versus perfusion
`11.3.1 Venous congestion
`Accuracy versus motion artifacts
`Accuracy versus optical interference
`Accuracy versus intravenous dyes
`
`126
`
`129
`130
`133
`134
`135
`143
`144
`149
`157
`
`158
`
`159
`
`159
`159
`162
`163
`164
`168
`173
`172
`173
`173
`174
`174
`175
`
`176
`
`176
`177
`178
`179
`
`179
`180
`180
`181
`181
`182
`182
`183
`184
`185
`
`30
`
`30
`
`

`

`
`
`187
`187
`188
`189
`190
`190
`190
`191
`192
`192
`192
`193
`194
`
`194
`195
`195
`196
`196
`197
`198
`
`199
`
`199
`200
`201
`203
`204
`206
`209
`210
`210
`211
`212
`213
`
`214
`
`214
`215
`216
`217
`
`Zt7
`218
`218
`219
`
`
`
`Contents
`
`Xill
`
`7
`
`11.8
`
`11.9
`
`11.10
`1
`
`11.12
`
`Effect of dyshemoglobins and fetal hemoglobin
`11.7.1 Carboxyhemoglobin (COHb)
`11.7.2 Methemoglobin (MetHb)
`11.7.3.
`Fetal hemoglobin
`11.7.4 Bilirubin
`Effect of temperature
`11.8.1 Ambient temperature
`11.8.2 Patient temperature
`Accuracy versus medical conditions
`11.9.1 Cardiac arrhythmia
`11.9.2 Myxoma
`Accuracy versus probe position
`Electromagnetic interference
`11.11.1 Interference from
`magnetic resonance imaging (MRI)
`Other effects on accuracy
`11.12.1 Exercise
`11.12.2 Dried blood
`11.12.3 Pigments
`References
`Instructional objectives
`
`USER INTERFACE FOR A PULSE OXIMETER
`Albert Lozano-Nieto
`
`1251
`12.2
`
`12.3
`12.4
`12.5
`12.6
`12.7
`12.8
`
`Introduction
`Front Panel
`12.2.1 Graphical displays
`12.2.2 Numerical displays
`Function controls
`Alarm controls
`Communicative functions
`Cables and Connectors
`Other features
`Compliance requirements
`References
`Instructional objectives
`
`13
`
`APPLICATIONS OF PULSE OXIMETRY
`Joanna B Ruchala
`
`13.1
`
`13.2
`
`13.3
`
`Anesthesia
`13.1.1 Problems encountered during induction to anesthesia
`13.1.2 Surgery under anesthesia
`Monitoring tissue blood supply and organ viability
`13.2.1
`Intestinal blood flow and
`bowelviability following surgery
`13.2.2 Tissue transfer and setting of limb fractures
`13.2.3. Dental pulp blood supply andviability
`Monitoring on the road and in the air
`
`31
`
`

`

`XIV
`
`Contents
`
`13.4
`
`13:7
`13.8
`13.9
`13.10
`13.11
`13.12
`
`13.3.1 Ambulances
`13.3.2 Flight
`Childbirth
`13.4.1 Causes of desaturation in mother and fetus
`13.4.2 Special apparatus for fetal monitoring
`Neonatal and pediatric care
`Sleep studies and physicalstress testing
`13.6.1
`Sleep
`13.6.2 Exercise
`Managementof cardiopulmonaryresuscitation
`Computer-controlled oxygen weaning
`Systolic blood pressure measurement
`Cerebral oxygen measurement
`Veterinary care
`Future improvements for pulse oximetry
`References
`Instructional objectives
`
`GLOSSARY
`
`INDEX
`
`219
`
`221
`221
`222
`224
`227
`227
`231
`231
`232
`232
`232
`233
`234
`234
`236
`
`237
`
`243
`
`32
`
`32
`
`