Folie 1 - UAS Technikum Wien

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Transcript Folie 1 - UAS Technikum Wien

last lecture:
Biofeedback: Principles and Applications
Brain Computer Interfaces – Theory and Methods
today:
Design Standards for biomedical devices
Device Certification
File Formats and Data Transfer Standards
Safety of medical devices
● Electrical Safety
double Isolation, safety grounding, clearence
galvanic isolation, isolation barriers
● Electrostatic Discharge (ESD-) Protection
prevention of device damage
or degradation of protective circuits
● Electromagnetic Compatibility (EMC, EMV)
capacitive or inductive coupling, resonance
RF / radiation levels, device interference
● Software Safety
● biocompatibility, radiation, riskmanagement, …
International and National Organisations:
International Electrotechnical Commission (IEC)
International Organization for Standardization (ISO)
Institute of Electrical and Electronics Engineers (IEEE)
Comité international spécial des perturbations radioélectriques (CISPR)
(Internationales Sonderkomitee für Funkstörungen)
European Committee for Electrotechnical Standardization (CENELEC)
European Telecommunications Standards Institute (ETSI)
American National Standards Institute (ANSI)
Österreicisches Normungsinstitut
Current European Union regulation
● based on the “New Approach” (CE marking)
● applicable processes depend on risk-category
● government-appointed Notified Bodies certify
the conformity assessment procedures
● improvements often result from user feedback
Methods to assure Safety
● Certification and harmonization of design standards
Directive 93/42/EWG Medical products
Directive 90/385/EWG Active implants
Directive 98/79/EG In-vitro diagnostic devices
ISO / EN 60601-2
EN 540 (EN ISO 14155) clinical Evaluation
EN 1041 Information by the manufacturer
● Risk management and labelling
EN 1441 risk analysis, EN ISO 14971 risk management
EN 980 Graphical symbols and labeling
Methods to assure Safety
● Safety-Zones
No-Cell Phones in critical areas, no metallic objects near MRI, …
● Dependability, Fail-Safety, Fault Tolerance
Redundancy in Hardware and Software
● Guidelines
„MEDDEVS“ of the European Comission
NB-Med Recommendations
Global Harmonization Task Force (GHTF)
Law for the admission of medical devices:
Österreichisches Medizinprodukte=
gesetz (MPG), BGBl. Nr. 657/1996:
● Definition of medical devices
● Classification of risk
● CE – admission
● clinical evaluation
● Registration, responsibility:
menufacturer, seller, …
● intended usage
Electrical Safety - some definitions
Clearance: The shortest distance between two conductive parts, or between a
conductive part and the bounding surface of the equipment, measured through
air
Hazardous Energy Level: A stored energy level of 20J or more, or an available
continuous power level of 240 VA or more, at a potential of 2V or more.
Hazardous Voltage: A voltage exceeding 42.4V peak or 60V d.c., existing in a
circuit which does not meet the requirements for either a Limited Current Circuit
or a TNV Circuit.
Limited Current Circuit: A circuit which is so designed and protected that , under
both normal conditions and a likely fault condition, the current which can be
drawn is not hazardous.
Safety Critical: A component which affects the safety of the equipment. All
components in primary circuitry are safety critical. Other components which
protect the equipment under normal and fault conditions, such as thermal
switches, optocouplers, etc. are also safety critical.
Electrical Safety - some definitions
Touch Current: Electric current through a human body when it touches one or
more accessible parts. (Touch current was previously included in the term
'leakage current')
Insulation according to IEC 664 / VDE 0110 (1/89): Data for insulation
coordination requires values for rated voltage, pollution degree and overvoltage
category.
Overvoltage category: Classification of electrical equipment to the overvoltage
to be expected.
Surge voltage: Amplitude of a voltage impulse of short duration with a specified
impulse form and polarity that is applied to test insulation paths in
device/component. This proves that the device/component (for example relay)
will withstand very high overvoltages for very short periods.
Electrical Safety - some definitions
Class I: Equipment where protection against electric shock is achieved by using
basic insulation, and also providing a means of connecting to the protective
earthing conductor in the building wiring those conductive parts that are
otherwise capable of assuming hazardous voltages if the Basic Insulation fails.
Class II: Equipment in which protection against electric shock does not rely on
basic insulation only, but in which additional safety precautions, such as double
insulation or reinforced insulation, are provided, there being no reliance on
either protective earthing or installation conditions.
Medical types B and BF (EN60601): Maximum leakage 100 microamperes, 4000V
voltage rating with 60 second test
Medical type CF (EN60601): Maximum leakage 10 microamperes, 4000V voltage
rating with 60 second test
Electrical safty - IEC 60601 examples
Safety Class I
metallic enclosure grounded
via earth wire
Safety Class II
enclosure seperated with double or
hardened isolation
Example guidelines for
electrical isolation
Safety Class III
Power Supply <= 25V AC
Device types, labels - IEC 60601 examples
● device type B („body“)
Leakage current < 0.1 mA
Can be grounded
● device type BF („body floating“)
Leakage current < 0.1 mA
Isolated from ground
● device type CF („cardiac floating“)
Leakage current < 0.01 mA
special Isolation
EMC - European standards
EN 55011 Interference emission from industrial, scientific and medical devices (ISM appliances)
EN 55013 Interference emission from radio receivers and consumer electronic appliances
EN 55020 Interference immunity of radio receivers and consumer electronic appliances
EN 55014-1 Interference emission from household appliances
EN 55014-2 Interference immunity of household appliances
EN 55015 Interference emission from electric lighting equipment
EN 61547 Interference immunity of electric lighting equipment
EN 55022 Interference emission from information technology equipment (IT appliances)
EN 55024 Interference immunity of information technology equipment (IT appliances)
EN 61000-4-2 Interference immunity to electrostatic discharge (ESD)
EN 61000-4-3 Interference immunity to electromagnetic fields
EN 61000-4-4 Interference immunity to fast transient orders of interference (burst)
EN 61000-4-5 Interference immunity to surge voltage
EN 61000-4-6 Interference immunity to conducted orders of interference induced by high frequency fields
EN 61000-4-8 Interference immunity to magnetic fields with energy technology frequencies
EN 61000-4-11 Interference immunity to voltage drops, short-time interruptions and voltage fluctuations
EN 50081-1 Interference emission from appliances in the household area
EN 50081-2 Interference emission from appliances in the industrial area
EN 50082-1 Interference immunity of appliances in the household area
EN 50082-2 Interference immunity of appliances in the industrial area
EN 61000-6-2 Interference immunity of appliances in the industrial area
EN 61000-3-2 Reactions in electricity supply systems - harmonic oscillations
EN 61000-3-3 Reactions in electricity supply systems - voltage fluctuations
EN 60601-1-2 EMC medical electric appliances
ESD Protection - Standards
ANSI ESD STM5.1:2001—Electrostatic discharge sensitivity testing—Human body model.
ANSI ESD STM5.2:1999—Electrostatic discharge sensitivity testing—Machine model.
ANSI ESD STM5.3.1:1999—Charged device model (CDM)—Component level.
ESD Association Advisory Documents : ESD ADV1.0:2004—Glossary of terms.
IEC 61000-4-2:1995—Electromagnetic compatibility (EMC)—Part 4: Testing and measurement
techniques—Section 2: Electrostatic discharge immunity test; Amendment 2:2001.
IEC 61340-2-2:2000—Electrostatics—Part 2-2: Measurement methods—Measurement of chargeability.
IEC 61340-2-3:2000—Electrostatics—Part 2-3: Methods of test for determining the resistance and
resistivity of solid planar materials used to avoid electrostatic charge accumulation.
IEC 61340-3-1:2002—Electrostatics—Part 3-1: Methods for simulation of electrostatic effects—Human
body model (HBM)—Component testing (IEC/101/33/CD).
IEC 61340-3-2:2002—Electrostatics—Part 3-2: Methods for simulation of electrostatic effects—Machine
model (MM)—Component testing (IEC/101/34/CD).
IEC 61340-4-1:2003—Electrostatics—Part 4-1: Standard test methods for specific applications—Section 1:
Electrostatic behavior of floor coverings and installed floors.
Product Safety Standards – IEC 60601
IEC 60601-1:2005—Medical electrical equipment—Part 1: General requirements for safety.
IEC 60601-1-2:2004—Medical electrical equipment—Part 1: General requirements for safety—Section 2:
Collateral standard—Electromagnetic compatibility—Requirements and tests; Amendment 1:2004.
IEC 60601-1-3:1994—Medical electrical equipment—Part 1: General requirements for safety—Section 3:
Collateral standard—General requirements for radiation protection in diagnostic x-ray equipment.
IEC 60601-1-4:2000—Medical electrical equipment—Part 1-4: General requirements for safety—Collateral
standard: Programmable electrical medical systems.
IEC 60601-2-1:1998—Medical electrical equipment—Part 2-1: Particular requirements for the safety of
electron accelerators in the range of 1 to 50 MeV; Amendment 1:2002.
IEC 60601-2-2:1998—Medical electrical equipment—Part 2-2: Particular requirements for the safety of
high-frequency surgical equipment.
IEC 60601-2-3:1991—Medical electrical equipment—Part 2-3: Particular requirements for the safety of
short-wave therapy equipment; Amendment 1:1998.
IEC 60601-2-4:2002—Medical electrical equipment—Part 2-4: Particular requirements for the safety of
cardiac defibrillators and cardiac defibrillator monitors.
IEC 60601-2-5:2000—Medical electrical equipment—Part 2-5: Particular requirements for the safety of
ultrasonic physiotherapy equipment.
Product Safety Standards – IEC 60601
IEC 60601-2-25:1993—Medical electrical equipment—Part 2-25: Particular requirements for the safety of
electrocardiographs; Amendment 1: 1999.
IEC 60601-2-26:2002—Medical electrical equipment—Part 2-26: Particular requirements for the safety of
electroencephalographs.
IEC 60601-2-27:2005—Medical electrical equipment—Part 2-27: Particular requirements for the safety of
electrocardiographic monitoring equipment.
IEC 60601-2-28:1993—Medical electrical equipment—Part 2-28: Particular requirements for the safety of xray source assemblies and x-ray tube assemblies for medical diagnosis.
IEC 60601-2-29:1999—Medical electrical equipment—Part 2-29: Particular requirements for the safety of
radiotherapy simulators.
IEC 60601-2-30:1999—Medical electrical equipment—Part 2-30: Particular requirements for the safety,
including essential performance, of automatic cycling noninvasive blood pressure monitoring
equipment.
IEC 60601-2-31:1994—Medical electrical equipment—Part 2-31: Particular requirements for the safety of
external cardiac pacemakers with internal power source; Amendment 1:1998.
Product Safety Standards – others
ISO 11197:2004—Medical electrical equipment—Particular requirements for safety of medical supply units
ISO/TR 16142:2006—Medical devices—Guidance on the selection of standards in support of recognized
essential principles of safety and performance of medical devices
ISO/IEC Guide 63:1999—Guide to the development and inclusion of safety aspects in international standards
for medical devices
IEC 60513:1994—Fundamental aspects of safety standards for medical electrical equipment.
EN 793:1998—Particular requirements for safety of medical supply units.
EN 45502-1:1998—Active implantable medical devices—Part 1: General requirements for safety, marking, and
information to be provided by the manufacturer
EN 50061—Medical electrical equipment—Safety of implantable cardiac pacemakers
EN 61204:1995—Low-voltage power-supply devices, dc output—Performance characteristics and safety
requirements; Amendment 1:2002
EN 60950:2000—Safety of information technology equipment; Corrigendum: 2002
CISPR 11 - Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment -- Electromagnetic Disturbance
Characteristics -- Limits and Methods of Measurement.
Product Safety
Standards –
IEC 60601
Summary of first and
Second edition
Software as a medical product
● Control algorithms for medical hardware
CT, pacemaker, …
● Data evaluation, visualisation
● Expert systems, databases
● Computer aided surgery, Tele-medical applications
● Risk Management Processes became essential
adapted from IEC 60601-1-4
● CDRH Center for Devices and Radiological Health
Guidance for the Content of Premarket Submissions for
Software Contained in Medical Devices
What does this all mean for our EEG device ?
Steps to get an EN-60601 CE certification:
● improvement of ESD protection for all inputs +15kV,
especially for the amplifier input pins (IEC 1000-4-2)
● improvement of isolation barrier (DC/DC converter and
optocouplers) to withstand 3kV permanently
● calibration procedurces in software, impedance checking
● certification by notified bodies:
Österreichisches Normeninstitut, TÜV
● last but not least: some money
(do not try this at home without € 20000 at hands )
Electrostatic Discharge Protection
ESD:
● One root cause of equipment failure
● Can happen during production and in field
● Errors often difficult to track, degrading performance
Example: RS232 interface chip after exposure to an ESD event of 15kV
ESD:
Origin of electrostatic chargeing - triboelectric effect:
materials with opposite surface charges come together
transfer of electrons from one material the other
seperation leaves a net-negative and a net-positive charge
ESD:
● low humidity prevents localized charges from moving
● Interaction of people with their surrounding can produce
significant charge:
Human body model:
100pF capacitance
charged upt to 15kV
1500 Ohm series resistance
When discharged, this setup produces a very fast rise time with
peak current of 15kV/1500Ohm = 10 A
ESD Testing standards
● Chip package pins
are tested against
other groups of pins
● I/O pins should be
tested seperately
ESD Testing standards
Four Levels of ESD compliance in the IEC 100-4-2 standard:
Contact and Air Gap discharge
ESD Testing
Example ESD waveform: rise time,
peak current, amplitude at 30 an 60 ns
Electron Microscope View of a Fused
Metallization Site, as a Result of
Electrical Overstress
ESD protection strategies / guidelines
● Capacitor protection / Resistor Protection to limit voltage / current
Layout and design compatibility needed
● Metal oxide varistors / silicon avalanche suppressor (TransZorb)
● Place bypass and charge-pump capacitors close to IC or I/O-port
● Include a ground plane on the PCB
● Use protection ICs (e.g. NUP 4201) and/or ESD protected ICs
● Proper grounding of persons and facility
● Suitable power up strategy for the circuit, consider maximum ratings
Further reading: Maxim Application Note 639 on ESD
Sources / Links
● Dr. Wolfgang Ecker: Skriptum Medizinproduktegesetz:
http://cis.technikum-wien.at/documents/bbe/5/srk/download/
● Articles by EisnerSafety http://www.eisnersafety.com
● Österr. Verband für Elektrotechnik (www.ove.at)
● Österr. Normungsinstitut (www.on.at)
● International Electrotechnical Commission (www.iec.ch)
● European directives
http://ec.europa.eu/enterprise/medical_devices/index_en.htm
http://ec.europa.eu/enterprise/electr_equipment/emc/
http://ec.europa.eu/enterprise/newapproach/legislation/guide/index.htm
● US Food and Drug Administration / Center for Devices and
Radiological Health (www.fda.gov/cdrh)
Standards for Communication and Modelling
DICOM – Digital Imaging and Communications in Medicine
● developed by ACR (American College of Radiology) and
NEMA (National Electrical Manufacturers Association )
● main purpose: transfer of image data (CT images)
● overcomes file format incompatibilities
● allows creation of distributed databases (TCP/IP)
● specifies semantics of commands and associated data
● Information Objects for images, waveforms, reports, printing …
● specifies levels of conformance, not implementation details
DICOM – General Communication Model
● Upper Layer service provides
independence from physical
networking
● Basic File Service provides
storage media access
DICOM Parts and Application Profile
Example configuration of an application, corresponding DICOM Parts
HL7 - Health Level Seven
● Non-Profit organisation, developing standards
for exchange of clinical and administrative data
● HL7 Reference Information Model (RIM)
representation of clinical data domains
● Special Interest Groups develop vocabulary, XML-integration,
Messaging Standards
● Objectives:
Messaging/Protocols, Query Sturctures, Medical Records
Patient Administration / Financial Management,
Clinical Order Entry, Laboratory Automation,
Application Management, Personnel Management
Security in Data Exchange (in respect to HIPAA, the Health Insurance
Portability and Accountability Act, 1996)
HL7 - Reference Information Model (RIM)
CDISC - Clinical Data Interchange Standards Consortium
● CDISC develops industry standards for electronic acquisition,
exchange, submission and archiving of clinical trials data
● Study Data Tabulation Model (SDTM):
Metadata Variable definitions: name, type, origin, role
Observation Classes: Interventions (medication etc.), Events, Findings
Relationships among Datasets and Records
Trial Design Model
File Formats for physiological data
File Formats: Proprietary EEG recording formats
Alpha-Trace DigitalEEG EEG, PAT, EVT
ASA (ANT Software B.V.) EEG
Axon Instruments EEG, PAT
Bio-logic CEEGraph1 EEG, PAT
Cadwell EEG, PAT, EVT
Cleveland Clinic Vangard EEG, PAT, EVT
EBNeuro Galileo DOS EEG, PAT, EVT
EBNeuro Galileo NT EEG, PAT, EVT
EEProbe AVR (ANT Software B.V.) EEG, EVT
Electrical Geodesics (EGI) EEG, PAT
EMS Pegasus 1 and 2 EEG, PAT
European Data Format EEG, PAT, EVT
Excel Tech NeuroWorks EEG, PAT, EVT
Micromed BrainQuick EEG, PAT, EVT, VIDEO
MPI Nijmegen (MPIData) EEG, PAT
Neuroscan AVG, CNT and EEG EEG, PAT, EVT
Nervus/Profile EEG, PAT, EVT, VIDEO
Nicolet AllianceWorks Intuition EEG, PAT, EVT
Nicolet BMSI 5000 EEG, PAT, EVT, VIDEO
Nicolet BMSI 6000 EEG, PAT, EVT, VIDEO
Nicolet Bravo Intuition EEG, PAT, EVT, VIDEO
Nicolet EEG Vue EEG, PAT, EVT
Nicolet UltraSom NT EEG, PAT, EVT
Nicolet Voyageur EEG, PAT
NCI Uniquant EEG, PAT, EVT, VIDEO
Nihon Kohden 2100 EEG, PAT, EVT
Persyst Layout (Exported Data) EEG
Schwarzer/OSG EEG, PAT, EVT
Stellate Harmonie EEG, PAT, EVT
Telefactor TUFF EEG, PAT
TMSI SMP EEG, PAT
Walter Graphtek EEG, PAT, EVT
EEG: EEG Data , PAT: Patient Information,
EVT: Event Data, MNT: Montage Information, VIDEO: Digital Video Data
Source: http://www.eemagine.com/fileformats.htm
File Formats: European Data Format - EDF and EDF+
● Simple format for exchange and storage of
multichannel biological signals
● Defacto standard for EEG recordings
● EDF was published in 1992, EDF+ in 2003
● EDF+ suports annotations and events -> EP, sleep stages etc.
● Hundreds of EDF+ files and several EDF+ viewers available
on the internet
● format description and demo applications:
http://www.edfpuls.info
File Formats: EDF - structure
HEADER RECORD
8 ascii : version of this data format (0)
80 ascii : local patient identification
80 ascii : local recording identification
8 ascii : startdate of recording (dd.mm.yy)
8 ascii : starttime of recording (hh.mm.ss)
8 ascii : number of bytes in header record
44 ascii : reserved
8 ascii : number of data records (-1 if unknown)
8 ascii : duration of a data record, in seconds
4 ascii : number of signals (ns) in data record
ns * 16 ascii : ns * label (e.g. EEG Fpz-Cz or Body temp)
ns * 80 ascii : ns * transducer type (e.g. AgAgCl electrode)
ns * 8 ascii : ns * physical dimension (e.g. uV or degreeC)
ns * 8 ascii : ns * physical minimum (e.g. -500 or 34)
ns * 8 ascii : ns * physical maximum (e.g. 500 or 40)
ns * 8 ascii : ns * digital minimum (e.g. -2048)
ns * 8 ascii : ns * digital maximum (e.g. 2047)
ns * 80 ascii : ns * prefiltering (e.g. HP:0.1Hz LP:75Hz)
ns * 8 ascii : ns * nr of samples in each data record
ns * 32 ascii : ns * reserved
DATA RECORDS
nr of samples[1] * integer : first signal in
the data record
nr of samples[2] * integer : second signal
..
nr of samples[ns] * integer : last signal
File Formats: Physionet and the WFDB tools
● WFDB: Waveform Database
a set of tools to read, annotate and convert physiological data
from the physiobank archive
● WFDB toolset includes c-libraries, signal viewers,
data and file conversion tools
● supported formats: AHA, HEA, MIT/BHI, Netfiles (remote on the web)
header-, signal-, annotation- and calibration files
● Link to physionet and the physiobank archives:
http://www.physionet.org
BIOSIG Toolbox, other file formats:
Biosig Toolbox by Alois Schlögl (TU-Graz) :
accessible from C / Python / Matlab / Octave
more than 30 import filters for common file formats
signal analysis tools
● BDF : a 24 bit extension of EDF, developed by BIOSEMI
● GDF/BKR : defined by TU-Graz
● DDB/DDF : Daisylab Data Files
● MFER: medical waveform encoding rules
● CEN/FEF: file exchange format for vital signs
● DAT: brain atlas EEG data file structure
● SIGIF: signal interchage format
Further information about file formats and the biosig toolbox:
http://hci.tugraz.at/schloegl/matlab/eeg
http://biosig.sourceforge.net/
The IEEE 11073 family of standards :
Personal Telehealth Devices Point of Care medical device communication
IEEE 11073 – The Scenario: E-Health Integration
Telecare Technology Vision: E-Health Interaction and Integration
Origins: IEEE 1073 “MIB”: Medical Information Bus
IEEE 1157 “MEDIX” : Medical Data Exchange
IEEE 11073 family of standards
● device standards for controlling information exchange
to and from personal telehealth devices and cell phones,
personal computers, personal health appliances and other
compute engines
● codes, formats and behaviors in a telehealth environment
to favor plug-and-play interoperability
● Capture and integration of medical instrumentation data generated
at the point of patient care to achieve a better understanding of the
condition of the patient
● CEN, ISO and IEEE cooperate to solve to the problem of
proprietary device- and communication standards
● could provide a link between device-level data and
HL-7 long term health records
IEEE 11073 family of standards
IEEE P11073-00103: Technical Overview: data exchange,
data representation and terminology for communication
between personal telehealth devices and computers
IEEE P11073-10400: Common Framework of communication,
managing devices and allow vendors to access
non-standard features.
IEEE P11073-10404: Pulse Oximeters
IEEE P11073-10406: Heart Rate Monitors
IEEE P11073-10407: Blood Pressure Monitors
IEEE P11073-10408: Thermometers
IEEE P11073-10415: Weighing Scales
IEEE P11073-10417: Glucose Meters
IEEE P11073-20401: Point-of-Care Medical Device Communication
Application Profile Common Networking Infrastructure,
IEEE P11073-20601: Device Communication Application Profile Optimized
Ex-change Protocol, which will define a common
framework for creating an abstract model of
personal health data
IEEE 11073 family of standards
Goal: interoperability
with existing medical
information systems
Method: object-oriented modelling of functionality
and areas of application (“Domain Information Model”)
Sources:
Thomas Norgall - ECG Data Interchange Formats and Protocols:
http://www.openecg.net/WS2_proceedings/Session05/S5.2_PR.pdf
Care Services Improvemnt Partnership: www.icn.csip.org.uk/telecare
IEEE 11073 – communication framework
The manager – agent framework
IEEE 11073 – some essential definitions
Agent: The embedded measurement device
Manager: The computing unit or data logger to which the Agent is connected
MDIB: Medical Data Information Base supplies an abstract object-oriented data
model representing the information and services provided by the medical device.
The objects include the Medical Device System (MDS), channels, numerics,
real-time sample arrays, alerts, and others
ACSE: Association Control Service Element provides services including
association request and response, association release, association abort
CMDISE: Common Medical Device Information Service Element, and
CMIP:
Common Management Information Protocol: provide basic services for
managed objects, including the performance of GET, SET, CREATE,
DELETE, ACTION, and EVENT REPORT functions
IEEE 11073 – some essential definitions
● A Scanner is a tool that collects information of various kinds from the device's MDIB
and sends it to the Manager in event-report messages. A periodic scanner will
examine a set of data items and send an update at regular intervals.
● A context scanner is used to report the object-model containment tree to the Manager
system. This way, the Manager can "discover" the data that are supported by a given
device during the Association State.
● Once the containment tree has been sent to the Manager system and the Agent has
received a confirmation reply, the state model passes to the Operation State, ready to
begin regular data communications
● PDUs (protocol data units) are the messages of the Common Medical Device Information
Service Element (CMDISE)
IEEE 11073 – communication framework
Step 1: Local Agent Initialisation
IEEE 11073 – communication framework
Step 1: Local Agent Initialisation
IEEE 11073 – communication framework
Step 2: Start of the
Association Procedure
IEEE 11073 – communication framework
Step 3: Start Configuration: Agent MDS reports itself to the Manager
IEEE 11073 – communication framework
Step 4: Manager Application creates Context Scanner in Agent MDIB
IEEE 11073 – communication framework
Step 5: Configuration : Agent sends Event reports,
Manager creates mirrored MDIB
IEEE 11073 – communication framework
Step 6: Manager reads attribute from agent using the GET service
IEEE 11073 – communication framework
Manager creates a scanner for automated attribute access
IEEE 11073 – communication framework
Scanner sends automated event reports
Further information on IEEE 11073 :
http://www.ieee1073.org/standards/1073standards.html
http://www.ieee1073.org/overview/ISO-IEEE11073-10201Annex.pdf
Thanks for your attention !