This document describes a proposed expert anesthesiology monitoring system. It would import data from a BIS monitor to determine a patient's level of consciousness and use the patient's personal information to recommend anesthesia dosages to the GE-Marquette anesthesia delivery system. The system would be developed using LabVIEW on a Blackfin processor and display data in real-time on an LCD screen. It aims to help anesthesiologists accurately determine dosages while maintaining the patient's amnesia, analgesia, and immobility during surgery. A budget outlines the necessary hardware components and potential costs. The document acknowledges sponsors and concludes the custom designed system would give anesthesiologists an enhanced analysis capability in the operating room.
Neuro-Stim System Neurostim FDA K140530 Electro Acupuncture Devicemcalipo
Neuro-Stim Electro Acupuncture device and Electro Acupuncture Stimulator. The Electro Auricular Device or PENS (Percutaneous Electrical Nerve Stimulation). Neurostimulation pain therapy medical devices deliver a therapeutic electrical signal into auricular nerves to help release endorphins and provide pain relief.
https://www.laserspineinstitute.com/spinal_orthopedic_procedures/neurostim/
Stivax neurostimulator and fda powerpointMaxiMedRx
STIVAX INNOVATIVE THERAPY: It goes without saying that tried and tested methods are the best therapy in medicine, with innovative, clinically-tested approaches providing a valuable complement for patient therapies. This is the basis for STIVAX therapy. The STIVAX NEUROSTIMULATION THERAPY is a conservative treatment for Chronic Pain and PAD patients extends walking distances to a multiple of original values and supports wound healing. The STIVAX STIMULATOR is a integral component of STIVAX therapy. The mechanism of action is based on the stimulation of the vagus nerve.
Attorneys Sabing Lee and Christy Lea presented a detailed webinar focusing on strategic considerations for medical device patents in Europe and the U.S.
An introduction to the concept of Telemedicine and how it aids in improving the health of people, along with a look into the telemedicine scenario in Malaysia.
Neuro-Stim System Neurostim FDA K140530 Electro Acupuncture Devicemcalipo
Neuro-Stim Electro Acupuncture device and Electro Acupuncture Stimulator. The Electro Auricular Device or PENS (Percutaneous Electrical Nerve Stimulation). Neurostimulation pain therapy medical devices deliver a therapeutic electrical signal into auricular nerves to help release endorphins and provide pain relief.
https://www.laserspineinstitute.com/spinal_orthopedic_procedures/neurostim/
Stivax neurostimulator and fda powerpointMaxiMedRx
STIVAX INNOVATIVE THERAPY: It goes without saying that tried and tested methods are the best therapy in medicine, with innovative, clinically-tested approaches providing a valuable complement for patient therapies. This is the basis for STIVAX therapy. The STIVAX NEUROSTIMULATION THERAPY is a conservative treatment for Chronic Pain and PAD patients extends walking distances to a multiple of original values and supports wound healing. The STIVAX STIMULATOR is a integral component of STIVAX therapy. The mechanism of action is based on the stimulation of the vagus nerve.
Attorneys Sabing Lee and Christy Lea presented a detailed webinar focusing on strategic considerations for medical device patents in Europe and the U.S.
An introduction to the concept of Telemedicine and how it aids in improving the health of people, along with a look into the telemedicine scenario in Malaysia.
I was coordinator of the software development of a project in the European Commission’ Telematic Applications Programme, DG XIII entitled “The Black Sea Tele Diab System (BSTD)”. The project was the result of a collaboration between members of the BSTD consortium, made up of the following partners: University of Sheffield (project coordinator) and University of Hull, UK; Research Institute and Diabetes Center, Greece; Institute of Diabetes, Nutrition and Metabolic Diseases, “N. Paulescu” and the Romanian Society Clinical Engineering and Medical Computing, Bucharest, Romania; Gorky State Medical University, Ukraine; Centre for Pathology, Chisinau, Moldova.
This system was carefully constructed and developed to meet the requirements to encourage clinicians to abandon paper records in favor of a fully-computerized healthcare record system and to promote the electronic exchange of healthcare information between clinicians and scientists in countries of the Black Sea area. The system was developed using a modular design and object oriented method approach. It was developped based on the Good European Health Record (GEHR) Architecture that faithfully preserving the data as originally intended, as well as permitting analysis of the data, which can come from many sources using an XML exchange method.
The GEHR structure is very comprehensive, data items being stored in a number of related tables that are held in a MS Access database. The software for the system has been developed in Microsoft Visual C++ and when combined with the database, it provides an application that is fast and well integrated with the Windows environment. Development of the system has followed a stepwise approach with validation of the architecture and the incorporation of feedback from users at each key stage.
There are five major work areas: patient records, reports, graphs, Diabetes Aggregated Data (DAD) and administration. Each of these contains a number of individual application/functions which are serviced by the relational tables that store the patient details, clinical measurements, doctors and user information. The Patient Records Function offers options for the management of the EHCRs (creation/correction/visualisation), such as: registration of a new patient and entry of the first record or sheet; the recording of a new sheet; the correction/visualisation of the sheet; the recording of data about the patient’s death, etc. The System Administration Function allows: Definition of the health care facility; definition of persons as users or system managers; management of passwords and access rights for the users; definition of measurement units; limited customisation of the user interface.
The fourth session in our "PV Loops to Measure Cardiac Function" Webinar Series touched on what is essential for the researcher to be aware of in order to collect valid Pressure-Volume Loop data that can be used with confidence in the ensuing analysis stage of their research project.
Dr. Filip Konecny and Peter Plouf present and offer discussion on best practices for obtaining quality and consistent Pressure-Volume loop data. The presentation is a distillation of more than 10 years of working with the PV Loop research community to develop better results, and insights from Dr. Konecny’s body of knowledge from collecting and publishing PV Loop study data across a wide spectrum of species and research models. This presentation touches on what is essential for researchers to be aware of in order to collect valid PV Loop data that can be used with confidence in the ensuing analysis stage of their research project.
Key Topics:
- surgical considerations for improved data stability and consistency between animals
- procedure checklists -- essential steps before, during, and post surgery
- how to properly check data integrity at the bench-top
- understanding conductance and admittance methodologies for deriving volume
What Happens After Your Device is Approved? Collecting Data in the Real WorldMedpace
In this workshop, Medpace will discuss key considerations for generating real-world evidence and how to apply critical insights in order to drive late-stage clinical research. To listen to this presentation, visit https://vimeo.com/168768256
I was coordinator of the software development of a project in the European Commission’ Telematic Applications Programme, DG XIII entitled “The Black Sea Tele Diab System (BSTD)”. The project was the result of a collaboration between members of the BSTD consortium, made up of the following partners: University of Sheffield (project coordinator) and University of Hull, UK; Research Institute and Diabetes Center, Greece; Institute of Diabetes, Nutrition and Metabolic Diseases, “N. Paulescu” and the Romanian Society Clinical Engineering and Medical Computing, Bucharest, Romania; Gorky State Medical University, Ukraine; Centre for Pathology, Chisinau, Moldova.
This system was carefully constructed and developed to meet the requirements to encourage clinicians to abandon paper records in favor of a fully-computerized healthcare record system and to promote the electronic exchange of healthcare information between clinicians and scientists in countries of the Black Sea area. The system was developed using a modular design and object oriented method approach. It was developped based on the Good European Health Record (GEHR) Architecture that faithfully preserving the data as originally intended, as well as permitting analysis of the data, which can come from many sources using an XML exchange method.
The GEHR structure is very comprehensive, data items being stored in a number of related tables that are held in a MS Access database. The software for the system has been developed in Microsoft Visual C++ and when combined with the database, it provides an application that is fast and well integrated with the Windows environment. Development of the system has followed a stepwise approach with validation of the architecture and the incorporation of feedback from users at each key stage.
There are five major work areas: patient records, reports, graphs, Diabetes Aggregated Data (DAD) and administration. Each of these contains a number of individual application/functions which are serviced by the relational tables that store the patient details, clinical measurements, doctors and user information. The Patient Records Function offers options for the management of the EHCRs (creation/correction/visualisation), such as: registration of a new patient and entry of the first record or sheet; the recording of a new sheet; the correction/visualisation of the sheet; the recording of data about the patient’s death, etc. The System Administration Function allows: Definition of the health care facility; definition of persons as users or system managers; management of passwords and access rights for the users; definition of measurement units; limited customisation of the user interface.
The fourth session in our "PV Loops to Measure Cardiac Function" Webinar Series touched on what is essential for the researcher to be aware of in order to collect valid Pressure-Volume Loop data that can be used with confidence in the ensuing analysis stage of their research project.
Dr. Filip Konecny and Peter Plouf present and offer discussion on best practices for obtaining quality and consistent Pressure-Volume loop data. The presentation is a distillation of more than 10 years of working with the PV Loop research community to develop better results, and insights from Dr. Konecny’s body of knowledge from collecting and publishing PV Loop study data across a wide spectrum of species and research models. This presentation touches on what is essential for researchers to be aware of in order to collect valid PV Loop data that can be used with confidence in the ensuing analysis stage of their research project.
Key Topics:
- surgical considerations for improved data stability and consistency between animals
- procedure checklists -- essential steps before, during, and post surgery
- how to properly check data integrity at the bench-top
- understanding conductance and admittance methodologies for deriving volume
What Happens After Your Device is Approved? Collecting Data in the Real WorldMedpace
In this workshop, Medpace will discuss key considerations for generating real-world evidence and how to apply critical insights in order to drive late-stage clinical research. To listen to this presentation, visit https://vimeo.com/168768256
Expert Anesthesia Monitoring System Final Presentation
1. Expert AnesthesiologyExpert Anesthesiology
Monitoring SystemMonitoring System
Team 2:Team 2: Timothy Morin, Nathan White, KaneTimothy Morin, Nathan White, Kane KilleleaKillelea
Sponsored by: Joseph H.Sponsored by: Joseph H. McIsaacMcIsaac and John D.and John D. EnderleEnderle
2. Sponsored By:Sponsored By:
JosephJoseph McIsaacMcIsaac
Contact Information:Contact Information:
JosephJoseph McIsaacMcIsaac, Ph.D.,, Ph.D.,
Chief, Trauma Anesthesia HartfordChief, Trauma Anesthesia Hartford
Hospital,Hospital,
Suite JB300, Department ofSuite JB300, Department of
AnesthesiologyAnesthesiology
80 Seymour80 Seymour St.HartfordSt.Hartford, CT 06102, CT 06102
(860) 545(860) 545--21172117
Jmcisaa@harthosp.orgJmcisaa@harthosp.org
JohnJohn EnderleEnderle
Contact Information:Contact Information:
EditorEditor--inin--Chief, EMB MagazineChief, EMB Magazine
Biomedical Engineering BookBiomedical Engineering Book
Series Editor for Morgan andSeries Editor for Morgan and
Claypool PublishersClaypool Publishers
Program Director & Professor forProgram Director & Professor for
Biomedical EngineeringBiomedical Engineering
University of ConnecticutUniversity of Connecticut
BronwellBronwell Building, Room 217CBuilding, Room 217C
260 Glenbrook Road260 Glenbrook Road
Storrs, Connecticut 06269Storrs, Connecticut 06269--22472247
(860) 486(860) 486--55215521
jenderle@bme.uconn.edujenderle@bme.uconn.edu
3. BackgroundBackground
•• Ideal Product Application:Ideal Product Application:
•• Development of an anesthesiology system that providesDevelopment of an anesthesiology system that provides
the anesthesiologist with an optimal method forthe anesthesiologist with an optimal method for
determining drug dosages throughout a surgicaldetermining drug dosages throughout a surgical
procedure.procedure.
•• The monitor will incorporate a patientThe monitor will incorporate a patient’’s personals personal
information.information.
•• The BIS monitoring system will provide the data forThe BIS monitoring system will provide the data for
determining the patientdetermining the patient’’s level of consciousness.s level of consciousness.
•• The GEThe GE--Marquette system will receive the output fromMarquette system will receive the output from
our device and apply the correct dosage.our device and apply the correct dosage.
4. Project GoalsProject Goals
•• UseUse LabVIEWLabVIEW to Create:to Create:
–– A clear visual display of data and dosage.A clear visual display of data and dosage.
–– Use Patient information to find a sufficient anesthesiaUse Patient information to find a sufficient anesthesia
dosage using:dosage using:
–– prior resistance, acute and chronic disease states, age,prior resistance, acute and chronic disease states, age,
weight, gender, exercise tolerance, medication usage, andweight, gender, exercise tolerance, medication usage, and
habits such as smoking, drug and alcohol use.habits such as smoking, drug and alcohol use.
–– Primary Functions:Primary Functions:
•• Import BIS monitor and GEImport BIS monitor and GE--Marquette, then apply theMarquette, then apply the
patients information to the data to determine a properpatients information to the data to determine a proper
dosage.dosage.
5. Project Goals (cont.)Project Goals (cont.)
•• The program should be reliable and easilyThe program should be reliable and easily
understood.understood.
•• The settings should be easily manipulated.The settings should be easily manipulated.
•• Front panel should display:Front panel should display:
–– Clear graphs with:Clear graphs with:
•• Corresponding numerical valuesCorresponding numerical values
•• Appropriate clear labelsAppropriate clear labels
–– Clean and purposeful appearanceClean and purposeful appearance
6. Project Goals (cont.)Project Goals (cont.)
•• Real Time ProcessingReal Time Processing
–– Simply put, itSimply put, it’’s processes data on a first ins processes data on a first in
first out basis.first out basis.
–– Optimization of the Software and hardware.Optimization of the Software and hardware.
•• Provides minimal processing timeProvides minimal processing time
•• Allows the device to display the most currentAllows the device to display the most current
patient status.patient status.
7. Patents ResultsPatents Results
•• Possible patent infringementPossible patent infringement
–– Vital signs monitoring system (1987)Vital signs monitoring system (1987)
–– Anesthesia machine with gas delivery system control and aAnesthesia machine with gas delivery system control and a
patient monitoring system (2002)patient monitoring system (2002)
–– Operative and postOperative and post--operative patient monitoring. Focusing onoperative patient monitoring. Focusing on
the relative power of the theta wave (2000)the relative power of the theta wave (2000)
•• Most patents deal with signal acquisitionMost patents deal with signal acquisition
–– Our device is the optimizing the current method of determiningOur device is the optimizing the current method of determining
dosages and providing an input to the GE Marquette deliverydosages and providing an input to the GE Marquette delivery
system.system.
8. Anesthesia MonitorsAnesthesia Monitors
•• GEGE--Marquette Anesthesia Delivery SystemMarquette Anesthesia Delivery System
–– Anesthesia delivery and patient monitoringAnesthesia delivery and patient monitoring
•• Aspect Medical BISAspect Medical BISTMTM
EEG monitorEEG monitor
–– Monitors the patientMonitors the patient’’s EEG signals EEG signal
9. BIS VistaBIS Vista
Advantages:Advantages:
•• ClearClear
•• AccurateAccurate
•• AlarmAlarm
•• Uses EEG toUses EEG to
determine level ofdetermine level of
consciousnessconsciousness
10. BISBISTMTM Monitoring system continued.Monitoring system continued.
•• Serial port: ASerial port: A--20002000
–– Asynchronous Serial CommunicationAsynchronous Serial Communication
–– DBDB--9 female adapter9 female adapter
–– Pin connections: 2,3,5Pin connections: 2,3,5
11. GEGE--Marquette Delivery SystemMarquette Delivery System
•• ClearClear
•• Accurate dosagesAccurate dosages
•• Ability for multipleAbility for multiple
anesthesiaanesthesia
medicationsmedications
•• Dosage recordsDosage records
•• Can import data fromCan import data from
other devices andother devices and
display.display.
13. The IdeaThe Idea
•• Importing of consciousness level from theImporting of consciousness level from the
Aspect BIS Anesthesia Monitor.Aspect BIS Anesthesia Monitor.
•• Use patients prior information to recommend aUse patients prior information to recommend a
dosage for the patient.dosage for the patient.
•• Time stamp will be done as the information isTime stamp will be done as the information is
received and for when the dosage is applied.received and for when the dosage is applied.
•• Output the data to the GEOutput the data to the GE--Marquette to supplyMarquette to supply
the dosage to the patient.the dosage to the patient.
14. PatientPatient’’s Prior Informations Prior Information
To determine a properTo determine a proper
dosage for a patientdosage for a patient
a few aspects musta few aspects must
be considered andbe considered and
calculated.calculated.
•• An example ofAn example of
Physical conditionPhysical condition
dosagedosage
adjustments.adjustments.
15. PatientPatient’’s Prior Informations Prior Information
•• Example of SexExample of Sex
diagnostic dosagediagnostic dosage
changes.changes.
•• A graphical display ofA graphical display of
how the dosages willhow the dosages will
change within ranges.change within ranges.
16. BlackfinBlackfin
•• BlackfinBlackfin will be able towill be able to
run therun the labviewlabview
program designedprogram designed
and display theand display the
relevant information.relevant information.
•• LCD, Buttons, AspectLCD, Buttons, Aspect
BIS monitor, and GEBIS monitor, and GE--
Marquette will allMarquette will all
attach to theattach to the balckfinbalckfin
for integration.for integration.
18. Material Requirements (cont.)Material Requirements (cont.)
•• Cooling FanCooling Fan
–– Mounted in the back ofMounted in the back of
the casethe case
–– Reduce internalReduce internal
temperature of thetemperature of the
devicedevice
21. BudgetBudget
Part Cost Shipping and Handling
Power Source – Double-Fused Three Function Power Entry Module $31.34 Unknown
Power Source cord $4.96 Unknown
UFO Cube Computer Case $299.99 Unknown
LCD6VGA 8” Open Frame TFT $599.99 $49.99
ADI Blackfin Processor $23.63 Unknown
Ultra Copper Core Cooling Fan $14.13 Unknown
(ON)-OFF SPST Momentary $2.50 $1
RS422 Serial Cables $7.50 $1.75
Resistor- 226-1058-ND $5 each Unknown
Capacitor -338-1364-ND $3 each Unknown
Op-Amplifiers- 296010025-2-ND $5.10 each Unknown
22. Budget (cont.)Budget (cont.)
•• Testing supplyTesting supply’’ss
•• Sensors for connectingSensors for connecting LabVIEWLabVIEW to theto the
subjects.subjects.
23. ConclusionConclusion
•• Expert Anesthesiology Monitoring SystemExpert Anesthesiology Monitoring System
–– This design should help to maintain the amnesia,This design should help to maintain the amnesia,
analgesia, and immobility of the patient with accuracyanalgesia, and immobility of the patient with accuracy
–– Custom designCustom design
–– Clear and AccurateClear and Accurate
–– Easy and FunctionalEasy and Functional
Utilizing biomedical engineering principles to enhanceUtilizing biomedical engineering principles to enhance
the abilities and analysis skills of the anesthesiologistthe abilities and analysis skills of the anesthesiologist
in the operating room that will give a new level ofin the operating room that will give a new level of
judgment capability.judgment capability.
24. AcknowledgementsAcknowledgements
We would like to Thank:We would like to Thank:
•• JohnJohn EnderleEnderle
•• WilliamWilliam PruehsnerPruehsner
•• JosephJoseph McIsaacMcIsaac
•• AnastasiosAnastasios MaurudisMaurudis
•• DavidDavid KaputaKaputa