11 december 20051 architectural overview & requirements brainstorm phoenix ambulatory blood...
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11 December 2005 1
Architectural Overview & Requirements Brainstorm
Phoenix Ambulatory Blood Pressure Monitor
© 2005 Christopher J. Adams
Copying and distribution of this page is permitted in any medium, provided this notice is preserved
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11 December 2005 2
Table of Contents
• 5 minutes of requirements (skip)
• 30 seconds of constraints (skip)
• Major subsystem interfaces• Diary subsystem (skip)
• Analysis software subsystem (skip)
• Device subsystem (requirements only — skip architecture)
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11 December 2005 3
Requirements
• Collects a week of blood pressure measurements
• Inexpensive
• Unobtrusive
• Easy to use
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11 December 2005 4
RequirementWeek of Measurements
• Records measurements at least every half hour for at least 7 days
• Measures systolic and diastolic blood pressure
• Measures heart rate• Measures physical activity• Measures blood flow
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11 December 2005 5
RequirementInexpensive
• Price is not a barrier to using the monitor
• Less expensive than:– Blood pressure cuff– Wrist watch (<$50)– “Two bushels of yams” (<$10)
• 3rd-world friendly
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11 December 2005 6
RequirementUnobtrusive
• When in place– Patient can forget about it — not be aware of it– No more encumbering than
• wrist watch• band-aid• piece of jewelry
• Usable wherever the patient is, such as at home or at work when allowed– Not just for hospital, clinic or doctor's office
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11 December 2005 7
RequirementEasy to Use
• Better than devices with blood pressure cuffs:– Easier to use
– Equally accurate
• Patient:– Should be able to ignore it, but
– Can determine whether functioning normally
– Can observe a blood pressure and heart rate measurement
• Automatic — measurements taken regardless of patient behavior
• Allows manually initiated measurements
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11 December 2005 8
Constraints
• Open-source– Major impact on design
• Must be buildable by fluid, virtual organization
• Developers have major say in content
• 3rd-party components must pass licensing constraints
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11 December 2005 9
Recap
• 5 minutes of requirements
• 30 seconds of constraints
• Major subsystem interfaces • Diary subsystem
• Analysis software subsystem
• Device subsystem
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11 December 2005 10
Major Subsystems & Interfaces
• Monitor measures the Wearer• Wearer records observations in the Diary• Administrator & Physiologist use Data Analysis Software to assess the
data collected by the Device• Diary influences the interpretation of the data• Clinical settings: data stored in Medical Record Systems
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11 December 2005 11
Diary Subsystem
• Observations influencing diagnosis
• Defined content– Patient identity (new subsystem?)
– Background, demographics
– Daily entries• Exceptions to background
• Multiple formats– Paper PDA– …
• Integrated device feature
• Could be an electronic device Phoenix ≈ 2+ devices
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11 December 2005 12
Analysis Software Subsystem
• Analysis Workstation– Handles data for a single wearer– Nominally a desktop application
– Multiple implementations • Clinical Care Support System• Personal care support tool
• Reference Data Workstation used by Chronobiology Center– Handles data for whole populations– Could be a distributed or internet application
• Analysis Workstation relies on model parameters from Reference Data Workstation
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11 December 2005 13
Recap
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11 December 2005 14
Device Subsystem• Small, wearable computer• Related subprojects:
– Low Power Microprocessor– Power
• Subsystem must be modular for easy substitution
• thin-film battery would be cool
• Real-time embedded software
• Execution software =?– RTOS? OS? No OS?
• Functionality may be allocated to multiple, linked devices
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11 December 2005 15
Device Subsystem
• Display• Keypad• Sensors
– Blood pressure– Heart rate– Body motion– Blood flow
• Issues– Sensor proximity & bundling– Number of devices
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11 December 2005 16
Device Subsystem
1. Clock
2. Identity
3. Diary
4. Calibration
5. Device status
6. Biometrics
7. Data transfer
8. Data acquisition
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11 December 2005 17
RequirementsClock
• Timestamp every sample– Include date
– Record in UCT
• Display time-of-day for diary recording– Display precision = 1 minute
– Do not display date
– Display in local time need timezone
• Precision– Current devices require about 1 minute to take a single measurement
– Sampling Beat-to-beat 300 beats per min x 25 samples per cycle = 125 samples per sec = 8 msec per sample precision = 1 msec
• Set time, date, and timezone at “initialization”
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11 December 2005 18
RequirementsIdentity (Onboard/Offboard)
• Unique device id– Serial number of instrument
• Unique patient id– Issues:
• HIPAA constraints (Health Insurance Portability & Accountability Act of 1996)
– Individually Identifiable Health Information (IIHI)
– Protected Health Information (PHI)
• Do not yet know if patient ID is needed onboard
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11 December 2005 19
Requirements Diary (Onboard)
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11 December 2005 20
RequirementsDevice Status
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11 December 2005 21
RequirementsCalibration
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11 December 2005 22
RequirementsBiometrics (Onboard)
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11 December 2005 23
RequirementsData Transfer—Standards
• HL7• IEEE 1073, “Standard for
Medical Device Communications”– Defines “Medical
Information Bus”– May be superceded
• ISO/IEEE 11073, “Standards for Point-of-Care Medical Device Communication”
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11 December 2005 24
RequirementsData Transfer—Content
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11 December 2005 25
RequirementsData Acquisition
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11 December 2005 26
UI Requirements
• Display• Keypad