Medical Device Communications - nxp.com

July 2009 TM

Medical Device Communications

USB and Zigbee®

José Fernández Villaseñor, M.D.

MSG Medical Product Marketing

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Continua Health Alliance

►The Continua Alliance is a forum of member companies that have
come together to form workgroups to set standards for medical
systems.

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service names are the property of their respective owners. © Freescale Semiconductor, Inc. 2009. Application
Hosting Devices

LAN/WAN
Devices

TM

2

TCP/IP Use Model

►Ethernet is the most common use model.

►Continua Ethernet Use Model
►Here the Continua host/manager and the target Continua device is

connected using an Ethernet cable. The TCP/IP stack is the
transmission medium of for IEEE® 11073 protocol APDU’s. The
host and agent functionality can also co-exist on a single machine
as well with a loopback link.

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USB Use Model

► An agent machine running the agent application as well as the data exchange layer
is connected to an embedded board using Ethernet. The embedded board accepts
the Ethernet data, and using the PHDC USB class, pushes the data through a USB
channel to a manager machine, which implements the IEEE 11073 protocol for the
manager as well as the manager GUI application.

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Continua Device Software Layer Architecture

-00103 Technical Report - Overview

Device Specializations

-10404 -10407 -10417 -10406 -10415 -10408 Phase II OSI
Pulse Blood Glucose Pulse Weighing Thermometer …
Oximeter Pressure
Scale

-10404 Common Framework Layers 5-7
-20601 Optimized Exchange Protocol

Serial IrDA Bluetooth USB ZigBee Layers 1-4

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Use Cases: Low-end PAN Device

In this model the medical device connects directly to the system and
passes the measurements to the system after acquisition.

Low Level
USB Driver

PHDC Class
Limited Data
Exchange
Input from sensors
Application

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PHD Bridge Model

In this use case the device implements a bridge between the application hosting system and the
medical device that acquires the measurement. As shown in the figure, this bridge device would
implement the low-level driver, the PHDC class and a serial shim layer that forwards the data it
receives (through a serial cable) to the external connected medical device. It also sends the data
received from this external medical device to the system running the IEEE11073 manager.

Low Level

Driver
USB

PHDC Class

Serial shim Serial Shim Layer
Data Elaxycehrange Application

Measurement
Acquisition

Medical Medical
Device Device

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PAN Device

These devices, with adequate RAM, ROM and processing power, will
implement agent/device functionality. They will be mostly running on ColdFire
V1 or higher power MCU’s with more than 64K flash and 8K RAM.

Low Level
USB Driver

PHDC Class

LimitedData
Exchange

Input from sensors
Application

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Application Hosting Device

These devices will implement host/manager functionality. They can run on an
embedded device running an RTOS, or they can run as an application on a
PC. These devices will have the ability to connect to one or more PAN
devices over one or more transports. They can also be connected to the
LAN/WAN IF’s to send this data over the transport.

Medical USB Low Level Driver
Device
PHDC Class
Medical Data Exchange
Device
Medical Data Processing
Bridge Application

Medical Serial
Device

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Hybrid Devices

►Hybrid devices will implement host/manager as well as agent/device
functionality.

►They will initialize themselves as a manager or agent, based on the
user’s choice. When they are connected managers, they will act as
agents and vice-versa. These kinds of devices will use the OTG
feature of the USB transport.

►This device can be used in remote areas as a manager to collect
data from agents. At the lab it can be connected to a manager and
act as an agent to send all the collected data. This is why manager
as well as device functionality is built into the same device.

►The use model would be represented by two modes.
►The hybrid device works as a host and acquires data from the

medical devices.

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Hybrid Device (Manager/Agent)

Medical USB Low Level Driver
Device
PHDC Class
Data Exchange

Medical Data Processing
Application and Store Records

USB Low Level
DPHriDveCr Class

Data Exchange

Transmit the Stored
Records

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Software Layers

Device Application Host Application
Device Data Exchange Host Data Exchange

Device Transport Host Transport

Wired / Wireless Physical Connection

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Continua Health Alliance Compliant Device
Blood Pressure Monitor Demonstration

►Continua Health Alliance established a standard that allows
interoperability between personal healthcare devices.

►A device compliant with this standard basically requires two things:

• USB or Bluetooth under PHDC standards to communicate with a host

• Data transmitted between the device and host must comply with IEEE
11073 standards

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Continua Health Alliance Compliant Device
Blood Pressure Monitor Demonstration

USB Personal Health Care Device Class

►Defines USB communication methods, which:

• Allow the device to be recognized by the host as a PHCD.
• Create communication pipes according to device-specific requirements,

such as QoS

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Continua Health Alliance Compliant Device
Blood Pressure Monitor Demonstration

IEEE 11073

►Defines:

• How to structure data to be transmitted (domain information model)
• What commands are to be used to access this data (service model)
• Communication states and what data is to be sent or requested in each

state (communication model)

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Continua Health Alliance Compliant Device
Blood Pressure Monitor Demonstration

Demo Application

►Device: blood pressure monitor

• JS16 for USB communication

►Host: PC with Windows OS

• Contains host application graphical user interface

►USB sniffer

• Used to display all data sent between the host and the device

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Continua Health Alliance Compliant Device

Blood Pressure Monitor Demonstration

Demo Application Step 1
►Take and store BP measurements

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Continua Health Alliance Compliant Device

Blood Pressure Monitor Demonstration

Demo Application Step 2
►Connect to host using USB communication

► Host recognizes device belonging to the
personal health care device (PHCD) class.

► Windows Device Manager may be opened
to show how it has installed the PHCD.

► During this step, the sniffer may be used to
demonstrate how the host enumerated the

device as a PHCD.

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Continua Health Alliance Compliant Device

Blood Pressure Monitor Demonstration

Demo Application Step 3
► Run user application.
► The application checks if a PHCD is connected and
attempts to “associate” as defined by the IEEE
11073 standard.

► If association is successful, the application displays
“The device is compatible with IEEE 11073
standard.”

► During this step, the sniffer may be used to
demonstrate how all data was transmited during the
associating procedure.

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Continua Health Alliance Compliant Device

Blood Pressure Monitor Demonstration

Demo Application Step 4

►Once we click ok, we are in what the IEEE defines as the
“configured” state.

►The device automatically sends all the data stored in its memory to
the host.

►During this step, the sniffer may be used to demonstrate how the
data is being transmitted.

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Continua Health Alliance Compliant Device

Blood Pressure Monitor Demonstration

Demo Application

Step 5

►There are two tabs at the bottom of the application.

Class: Displays all transmitted data in its User: Displays how the end user can
raw format as well as in a structured table. view and plot received data into a
This allows us to demonstrate that data chart with an adjustable calendar with
packets are structured according to different view options (day, week,
standard. month, year)

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service names are the property of their respective owners. © Freescale Semiconductor, Inc. 2009.
22

FSL Products for Continua Health Alliance Guidelines

Low end PAN Bridge Hybrid MQX MQX MQX
PAN Device Device Device PAN Host Hybrid
Device Device Device Device

JS16

JM16
JM60
JM128
MM128
MM256
MCF5225x

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►48 MHz S08 or ColdFire V1 core Introducing the Flexis USB Family

►24 MHz bus frequency S08JM60 and MCF51JM128
►2.7V - 5.0V operating range

►Memory
►S08
►Up to 4 KBytes SRAM; up to 60 KB flash
►ColdFire V1

►Up to 16 KBytes SRAM; up to 128 KB flash

►Features S08JM60 Packages
►2x SCI, I2C, 2x SPI 64 LQFP, 64 QFP 48 QFN, 44 LQFP
►8-channel keyboard interrupt (KBI)
►16-bit timers: 1x 2-ch, 1x 6-ch ColdFire JM128 Packages
►12-bit 12-channel ADC 80 LQFP, 64 LQFP, 64 QFP, 44 LQFP
►Analog comparator
►Up to 51 general purpose I/O (GPIO) Temperature Range
►Multiple purpose clock generation (MCG) -40C to +85C
►PLL
►On-chip oscillator
►External crystal support
►Integrated CAN module (ColdFire V1 only)
►Cryptographic acceleration unit (ColdFire V1 only)

►Complete USB Solution
►Integrated USB device (S08) or USB OTG (ColdFire V1)
►Complimentary USB SW stack
►CodeWarrior for Microcontrollers
►Processor Expert

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JM60/32 Block Diagram and Features

► Supply Voltage / Performance 60K Flash Full Speed USB MCG
► 2.7V - 5.0 V operation 2.0 Device
► -40 to +85°C operation Comparator
4K RAM 2 SCI
► Features / Benefits 6-ch., 16-bit
► 2x SCI, I2C, 2x SPI 256Bytes USB 2 SPI Timer
► 8-channel KBI RAM KBI
► 16-bit timers: 1x 2-ch, 1x 6-ch 2-ch., 16-bit
► 12-bit 12-channel ADC S08 Core Indep. Clocked Timer
► Analog comparator COP
► Up to 51 GPIO 12-ch., 12-bit
► MCG ICE+BDM I2C ADC
RTC
• PLL
• On-chip oscillator Pricing
• External crystal support
► $2.90* MSRP at 10K units
► Memory
► Up to 4 KB SRAM; up to 60 KB flash *Varies by package

► Complete USB Solution
► Integrated USB device
► Complimentary USB SW stack
► CodeWarrior for Microcontrollers
► Processor Expert

► Packages
► 64 LQFP, 64 QFP 48 QFN, 44 LQFP

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► Features / Benefits MC9S08JM16/8

• Timers – 1x 2-ch, 1x 6-ch 39 I2C 2xSCI 2xSPI
• Upgraded SPI configurable for 8-bit or 16-bit data GPIO

length 8-ch 10-bit KBI COP
• Analog comparator ADC
• 8-ch keyboard interrupt (KBI)
• 8-bit 12-ch ADC 2-ch 16-bit RTC
• LVI Timer MCG
• 39 (muxed) GPIOs for 48-pin package
• Integrated USB 2.0 FS PHY and SIE 4-ch 16-bit Comparator
• MCG Timer

 PLL USB 2.0 FS
 On-chip oscillator PHY + SIE
 External crystal support
• On-chip ICE and BDM ICE + BDM

► Supply Voltage / Performance 16/8K 1K 128B
Flash RAM
• 2.7V - 5.0 V operation USB RAM
• -40 to +85°C operation
S08 Core
► Core
Last updated September 5, 2007
• 48 MHz HCS08 core
• 24 MHz bus frequency TM

► Memory 26

• 16K flash, 1K RAM, 128B USB RAM

► Communications

• SCI, SPI, I2C w/ broadcast mode feature

► Packages

• 32 LQFP, 44 LQFP, 48 QFN

► Pricing

• $1.99* MSRP at 10K units

*Varies by package

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service names are the property of their respective owners. © Freescale Semiconductor, Inc. 2009.

Op Amp: BIOSENSOR CF51MM256
•Trans impedance amp functionality
•Low pass filter Photodetector OR Coulometer Test Strip

16-bit SAR ADC Serial interface LCD
• Differential input mode
• 14.5 bit accuracy •Memory expansion: up to 4 MBytes Bus interface LCD
• Offset and gain control • 1 MB without glue logic
• Hardware average •Can drive memory interface LCD
• Window compare mode
TM
IRTC:
• Separate power 27
rails
• Power removal
detection

Motor Control

• EMAC
• Up to 25 MHz bus
• Very low power:
• Stop Idd : 0.550 μA
• Short Stop recovery

time: 6uS

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service names are the property of their respective owners. © Freescale Semiconductor, Inc. 2009.

Op Amp: BIOSENSOR S08MM128
•Trans impedance amp functionality
•Low pass filter Photodetector OR Coulometer Test Strip

16-bit SAR ADC Monochrome
• Differential input mode or
• 14.5 bit accuracy
• Offset and gain control segment LCD
• Hardware average
• Window compare mode TM

IRTC: 28
• Separate power
rails
• Power removal
detection

Motor Control

• Very low power:
• Stop Idd : 0.350 μA
• Short Stop recovery

time: 6uS

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service names are the property of their respective owners. © Freescale Semiconductor, Inc. 2009.

68K/ColdFire V2 Core 68K/ColdFire: MCF5225x

• Up to 76 Dhrystone 2.1 MIPS @ 80 MHz Proposal BDM PLL 32kHz GPI/O JTAG
• MAC module and HW divide Osc.
• Encryption – CAU 512KBytes USB
• External bus Flash otg 4ch 32-bit I2C UART
10/100 Timer
FEC
• 64 KB SRAM 64KBytes CAN 4ch 16-bit QSPI UART
• Up to 512 KB flash SRAM Timer

• 100K W/E cycles, 10 years data retention 256KBytes DMA RTC 8-ch 12-bit UART
• USB 2.0 full-speed host/device/OTG controller Flash ADC
• CAN – (FlexCAN)
• FEC (10/100 Ethernet) 32KBytes 2ch PIT 8ch 4ch DMA
• 3x UARTs SRAM PWM

• Queued SPI) Memory Options
• I2C bus interface modules
EZPORT
• 4 ch. 32-bit timers with DMA support Crypto RNGA EMAC V2 System Ext
• 4 ch. 16-bit capture/compare/PWM timers (CAU) ColdFire® Integration Bus
• 2 ch. periodic interrupt timer
• 8 ch. PWM timer with enhanced DAC capabilities Core
• 2nd Watchdog timer with independent clock
Optional

Part Number Freq Flash Encryption T emperature Packages Suggested 10K
K bytes (144 pin has Resale
• Real-time clock with 32 kHz crystal oscillator MCF5225x 80MHz No 0 to 70C
• 8 ch. 12-bit ADC with simultaneous sampling MCF5225x 66MHz 512 No -40 to +85C ext bus) $5.19
• Up to 56 5V-tolerant GPIO 256 No 0 to +70C $4.69
512 No -40 to +85C 100 LQFP $5.49
• System integration (PLL, SW watchdog) MCF5225x 80MHz 256 Yes -40 to +85C $4.99
• Single 3.3V supply MCF5225x 66MHz 512 Yes -40 to +85C 100 LQFP $5.99
• Temperature range: -40C to +85C 256 $5.59
512 144 LQFP $6.29
• Available speeds: 66 and 80 MHz MCF5225x 80MHz 256 144 MAPBGA $5.89

• Available packages: 100 LQFP, 144 LQFP, 144 BGA MCF5225x 80MHz 512 144 LQFP $7.49
144 MAPBGA
512 $8.29
100 QFP

144 LQFP
144 MAPBGA

• Target prices from $4.69 at 10K qty

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Freescale Introduces Product Longevity Program

►The embedded market needs long-term product support, which
allows OEMs to provide assurance to their customers.

►Freescale has a longstanding track record of providing long-term
production support for our products.

►Freescale is pleased to introduce a formal product longevity
program for the market segments we serve.

• For the automotive and medical segments, Freescale will manufacture
select devices for a minimum period of 15 years.

• For all other market segments in which Freescale participates,
Freescale will manufacture select devices for a minimum period of 10
years.

►A list of applicable Freescale products is available at
www.freescale.com.

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Q&A

►Thank you for attending this presentation. We’ll now take a few
moments for the audience’s questions, and then we’ll begin the
question and answer session.

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TM