medical device communications

TM

Freescale™ and the Freescale logo are trademarks of Freescale Semiconductor, Inc. All other product or service names are the property of their respective owners. © Freescale Semiconductor, Inc. 2009.

USB and Zigbee®

Medical Device Communications

July 2009

José Fernández Villaseñor, M.D.MSG Medical Product Marketing

TMFreescale™ and the Freescale logo are trademarks of Freescale Semiconductor, Inc. All other product or service names are the property of their respective owners. © Freescale Semiconductor, Inc. 2009. 2

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.

PAN Devices

Application Hosting Devices

LAN/WAN Devices


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.


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.


Continua Device Software Layer Architecture

-00103 Technical Report - Overview

Device Specializations-10404Pulse

Oximeter

-10407Blood

Pressure-10417

Glucose

-10415Weighing

Scale-10406Pulse

-10408Thermometer

Phase II…

-10404 Common Framework

-20601 Optimized Exchange Protocol

Serial IrDA Bluetooth

OSI

ZigBee

Layers 5-7

Layers 1-4USB


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.

USBLow Level DriverPHDC Class

Input from sensorsApplication

Limited Data Exchange


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.

Serial shim layerData Exchange

Measurement Acquisition

Low Level Driver

PHDC Class

Serial Shim Layer

Application

USB

Medical Device

Medical Device


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.

USB

Input from sensorsApplication

Low Level Driver

PHDC Class

LimitedData Exchange


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 Device

Low Level Driver

PHDC Class

Data Exchange

Medical Data Processing Application

Serial

Medical Device

Medical Device

BridgeUSB


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.


Hybrid Device (Manager/Agent)

USBLow Level Driver

PHDC Class

Medical Data Processing Application and Store Records

Data Exchange

Medical Device

USBLow Level DriverPHDC Class

Transmit the Stored Records

Data Exchange


Software Layers

Device Application

Device Data Exchange

Device Transport

Wired / Wireless Physical Connection

Host Application

Host Data Exchange

Host Transport


Continua Health Alliance Compliant DeviceBlood 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



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



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)



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



Demo ApplicationStep 1

►Take and store BP measurements



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.




►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.




►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.




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

Class: Displays all transmitted data in its raw format as well as in a structured table. This allows us to demonstrate that data packets are structured according to standard.

User: Displays how the end user can view and plot received data into a chart with an adjustable calendar with different view options (day, week, month, year)


FSL Products for Continua Health Alliance Guidelines

Low end PAN Device

PAN Device

Bridge Device

Hybrid Device

MQX PAN Device

MQX Host Device

MQX Hybrid Device

JS16

JM16

JM60

JM128

MM128

MM256

MCF5225x


Introducing the Flexis USB Family S08JM60 and MCF51JM128

►48 MHz S08 or ColdFire V1 core►24 MHz bus frequency►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►2x SCI, I2C, 2x SPI►8-channel keyboard interrupt (KBI)►16-bit timers: 1x 2-ch, 1x 6-ch►12-bit 12-channel ADC►Analog comparator►Up to 51 general purpose I/O (GPIO)►Multiple purpose clock generation (MCG)►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

S08JM60 Packages64 LQFP, 64 QFP 48 QFN, 44 LQFP

ColdFire JM128 Packages80 LQFP, 64 LQFP, 64 QFP, 44 LQFP

Temperature Range-40C to +85C


JM60/32 Block Diagram and Features► Supply Voltage / Performance► 2.7V - 5.0 V operation► -40 to +85°C operation

► Features / Benefits► 2x SCI, I2C, 2x SPI► 8-channel KBI► 16-bit timers: 1x 2-ch, 1x 6-ch► 12-bit 12-channel ADC► Analog comparator► Up to 51 GPIO► MCG

• PLL• On-chip oscillator• External crystal support

► Memory► Up to 4 KB SRAM; up to 60 KB flash

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

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

25

Pricing► $2.90* MSRP at 10K units

*Varies by package

Full Speed USB 2.0 Device60K Flash

256Bytes USB RAM

4K RAM

S08 Core

ICE+BDM

Indep. Clocked COP

2 SCI

2 SPI

KBI

I2C

RTC

MCG

6-ch., 16-bit Timer

Comparator

2-ch., 16-bit Timer

12-ch., 12-bit ADC


MC9S08JM16/8► Features / Benefits• Timers – 1x 2-ch, 1x 6-ch• Upgraded SPI configurable for 8-bit or 16-bit data

length• Analog comparator• 8-ch keyboard interrupt (KBI)• 8-bit 12-ch ADC• LVI• 39 (muxed) GPIOs for 48-pin package• Integrated USB 2.0 FS PHY and SIE• MCG

PLL On-chip oscillator External crystal support

• On-chip ICE and BDM

► Supply Voltage / Performance• 2.7V - 5.0 V operation• -40 to +85°C operation

► Core• 48 MHz HCS08 core• 24 MHz bus frequency

► Memory• 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

S08 Core

1KRAM

16/8KFlash

39 GPIO

ICE + BDM

8-ch 10-bitADC

128BUSB RAM

2xSCI 2xSPII2C

Comparator

USB 2.0 FSPHY + SIE

KBI COP

4-ch 16-bitTimer

2-ch 16-bitTimer RTC

MCG

Last updated September 5, 2007


CoulometerPhotodetector

BIOSENSOR

OR Test Strip

Serial interface LCD

Op Amp:•Trans impedance amp functionality•Low pass filter

•Memory expansion: up to 4 MBytes• 1 MB without glue logic•Can drive memory interface LCD

Bus interface LCD

16-bit SAR ADC•Differential input mode•14.5 bit accuracy•Offset and gain control•Hardware average•Window compare mode

IRTC:• Separate power rails

•Power removal detection

• EMAC• Up to 25 MHz bus• Very low power:• Stop Idd : 0.550 μA• Short Stop recovery time: 6uS

Motor Control

CF51MM256


CoulometerPhotodetector

BIOSENSOR

OR Test StripOp Amp:•Trans impedance amp functionality•Low pass filter

Monochromeor

segment LCD

16-bit SAR ADC•Differential input mode•14.5 bit accuracy•Offset and gain control•Hardware average•Window compare mode

IRTC:• Separate power rails

•Power removal detection

• Very low power:• Stop Idd : 0.350 μA• Short Stop recovery time: 6uS

Motor Control

S08MM128


68K/ColdFire V2 Core • Up to 76 Dhrystone 2.1 MIPS @ 80 MHz• MAC module and HW divide• Encryption – CAU• External bus• 64 KB SRAM• Up to 512 KB flash

• 100K W/E cycles, 10 years data retention • USB 2.0 full-speed host/device/OTG controller• CAN – (FlexCAN)• FEC (10/100 Ethernet)• 3x UARTs• Queued SPI)• I2C bus interface modules• 4 ch. 32-bit timers with DMA support• 4 ch. 16-bit capture/compare/PWM timers• 2 ch. periodic interrupt timer• 8 ch. PWM timer with enhanced DAC capabilities• 2nd Watchdog timer with independent clock• Real-time clock with 32 kHz crystal oscillator• 8 ch. 12-bit ADC with simultaneous sampling• Up to 56 5V-tolerant GPIO• System integration (PLL, SW watchdog)• Single 3.3V supply• Temperature range: -40C to +85C• Available speeds: 66 and 80 MHz• Available packages: 100 LQFP, 144 LQFP, 144 BGA

• Target prices from $4.69 at 10K qty

Optional

68K/ColdFire: MCF5225x

Part Number Freq FlashK bytes Encryption Temperature

Packages(144 pin has

ext bus)

Suggested 10K Resale

MCF5225x 80MHz 512256 No 0 to 70C 100 LQFP $5.19

$4.69

MCF5225x 66MHz 512256 No -40 to +85C 100 LQFP $5.49

$4.99

MCF5225x 80MHz 512256 No 0 to +70C 144 LQFP

144 MAPBGA$5.99$5.59

MCF5225x 66MHz 512256 No -40 to +85C 144 LQFP

144 MAPBGA$6.29$5.89

MCF5225x 80MHz 512 Yes -40 to +85C 100 QFP $7.49

MCF5225x 80MHz 512 Yes -40 to +85C 144 LQFP144 MAPBGA $8.29

GPI/O JTAGPLLBDM

SystemIntegration

UART

RTC

QSPIUSB otg UART

EMAC

V2ColdFire®

Core

8-ch 12-bitADC

4ch DMA

Memory Options

512KBytesFlash

64KBytesSRAM

I2C

32kHzOsc.

UART

Proposal

2ch PIT 8chPWM

4ch 16-bitTimer

4ch 32-bitTimer

256KBytesFlash

32KBytesSRAM

CAN

10/100 FEC D

MA

EZPO

RT

ExtBusCrypto

(CAU) RNGA


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.


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.

medical device communications

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