Developer's Guide To Pacemaker Development

Tutorial 1.1: Pacemaker Project Overview

SFWRENG/MECHTRON 3K04
McMaster University
Michael Kehinde
[email protected]

September 20, 2020

Getting Started With The Pace-
maker Project
The purpose of this tutorial is to outline the vision, scope and goal of the
pacemaker project. Since a modest understanding of embedded systems is
required for the project, this document begins by providing an overview of
embedded systems. By the end of this tutorial, you will have gained a stronger
understanding of the system you will be developing for the course project. You
will have also begun to decompose the project requirements.

Topics Covered
• The pacemaker as an embedded system
• What am I building? Vision, goal and scope of the pacemaker project

Prerequisites “What Is A Pacemaker?: The Cardiac Conduction System

and the Artificial Pacemaker”

Developer’s Guide To Pacemaker Development 2

1 Background
1.1 Understanding the Pacemaker System

Embedded systems are all around us. If you use a thermostat to keep your
room warm so you can attend your online lectures comfortably,
if you use a laundry machine to do
your laundry, if you use a dishwasher
to wash your dishes, or a microwave
to heat up your food — you have in-
teracted with a machine with an em-
bedded system. From the modules in
a digital camera to the engine control
unit in an industry airplane, embed-
ded systems are an integral part of
life in our modern world.

Figure 1: Embedded System Examples

The pacemaker is an example of an embedded system. An embedded system

can be thought of as a computing system that is made up of hardware that is
controlled by software. Embedded systems, in contrast to general computing
systems, are designed and optimized to perform a specific, dedicated function
within a larger electrical or mechanical system. They are “embedded” into the

Rev. 1.0 Tutorial 1.1: Pacemaker Project Overview 3

system in which they control.

The following diagram illustrates the Input-Output (I/O) and Communica-

tion relationships of an embedded system. The blue arrows represent data or
communication channels; the red arrows represent control channels.

Figure 2: External Block Diagram of an Embedded System

The Embedded Computer: the core component of the embedded system.

In the context of the pacemaker system, the embedded computer is the pulse
generator.

Software: embedded software resides in the memory of the embedded com-

puter. The software governs the relationship between the input variables, the
output variables and timing. Pacemaker software implements bradycardia op-
erating modes and a communication protocol between the embedded computer
and the user interface. Bradycardia operating modes will be elaborated on in
Tutorial 2 — Pacing, Sensing and Timing Cycles.

Developer’s Guide To Pacemaker Development 4

User Interface: the user interface enables a person to interact with the em-
bedded computer via a set of sensory and controls channels. A user interface
may be local (i.e. an LCD screen, push buttons or dials mounted directly on the
embedded computer) or remote (i.e. a connection to a screen that is separate
from the unit and displays the status of the embedded computer). In the con-
text of the pacemaker system, the Device Controller-Monitor (DCM) includes
a remote graphical user interface (GUI) that allows the user to receive data
from the pacemaker device and, given that the pacemaker is programmable,
transmit a new set of instructions to alter the behaviour of the pacemaker
device.
Input variables: represent the physical connection between the pacemaker
leads and the Cardiac Conduction System (CCS) that allows the pulse gener-
ator to sense the electrical activity of the the heart.
Output variables: represent the physical connection between the pacemaker
leads and the Cardiac Conduction System (CCS) that allows the pulse gener-
ator to send electric stimuli to the heart.
Link to Other Systems: the pacemaker system does not interact with any
other system(s).

A Closer Look at the Embedded Computer

Embedded computer hardware is based on microprocessors or microcontrollers,
and is made up of a processor, memory devices, and peripherals.
Processor: a processor (CPU in Figure 3) is known as the “brain” of the sys-
tem. The processor executes the embedded program instructions by perform-
ing arithmetic operations, managing data flow, and generating the appropriate
control signals. The Arithmetic Logic Unit (ALU) and the Control Unit (CU)
make up the two parts of the processor that work together to fetch, decode
and execute instructions.
Memory: memory devices store programs or data for use by the processor.
Memory is primary classified based on persistence of data storage (also known
as volatility). Volatile memory hold their contents only as long as power is
supplied to the memory device and allow faster access to memory contents.
Nonvolatile memory, also known as persistent memory, retain their contents
even after power has been removed.
Peripherals: peripherals are IC devices that assist the processor. Most pe-
ripherals are used by the embedded computer to interface with the outside

Rev. 1.0 Tutorial 1.1: Pacemaker Project Overview 5

world. Of particular interest to the pacemaker system are timers, serial com-
munication ports and parallel ports (discussed below). Interrupt controllers
may also be advantageous.

(a) A Microprocessor-Based System. (b) Microcontroller-Based System

Figure 3: High-level Comparison of the Microprocessor-Based System and

Microcontroller-Based System.
Figure 3 illustrates the hardware configurations of a microprocessor-based sys-
tem and a microcontroller-based system. A microprocessor unit (MPU)
is an integrated circuit (IC) that contains all (and only) the functions of the
Central Processing Unit (CPU) of a computer. Memory and peripherals are
connected externally to the MPU chip to build an embedded computer. In
contrast, a microcontroller unit (MCU) has a CPU along with integrated
memory and/or peripheral interfaces on a single chip. MCUs are used to per-
form applications that have tasks that are fixed and predefined, whereas MPUs
are more desirable where intensive processing, and perhaps a flexible hardware
configuration, is required. When it comes to size, MCUs are more desirable
in applications where a small size is a key requirement. All else equal, MCUs
generally consume less power than MPUs because they are manufactured with
power management circuitry.

For our purposes, the pacemaker system is based on a MCU called the FRDM-
K64F (K64F). The K64F has most of the components shown in Figure
4 built into the board. For more information on the board’s features, re-
fer to: https://os.mbed.com/platforms/FRDM-K64F/ and https://inst.
eecs.berkeley.edu/~ee192/sp18/files/FRDMK64FUG.pdf.

Power Supply, Reset and Oscillator Circuit: generates a reset signal

when power is supplied to the system. The K64F receives power through a
USB cable connected to your personal computer.

Program Memory & Data Memory: the instructions to be executed by

Developer’s Guide To Pacemaker Development 6

 Figure 4: Embedded System — Internal Block Diagram.

the processor are stored in program memory; the data being manipulated
by the processor is stored in data memory. Celebrated for its high speed,
long life and electrical programmability, flash memory is the most common
program memory type in embedded systems. Flashing is a term that refers to
the process of writing a program to flash memory. Once the K64F is flashed,
it will execute the program every time the board is powered on. A typical
flash memory layout has a bootloader area and a program area. A bootloader
is a type of firmware (software that is “firm” — not intended to change)
that is executed before the main program. The bootloader contains the code
that communicates with your personal computer, accepts the main program
file/binary, and writes it to the program area.

Timers: a timer is a peripheral that counts processor cycles or clocks to

measure elapsed time. A timer is essential for the pacemaker system because

Rev. 1.0 Tutorial 1.1: Pacemaker Project Overview 7

 Figure 5: Flash Memory Layout.

it helps the pulse generator measure or generate time intervals that synchronize
the timing of the pulse generation or sensing operation.
Serial Communication Ports: provide an interface for serial communica-
tion with external devices. Serial communication is a process where data is
sent one bit at a time over a communication channel. Serial communication
is used by the K64F when you flash or debug pacemaker software, or when
you operate the DCM. Serial communication will be explored in more detail
in Tutorial 5 — Serial Communication.
Interrupt Controller: an interrupt controller listens to peripherals for events
and reports to processor once an event, an “interrupt”, occurs. The use of
interrupts is often contrasted with a process called polling. Polling is when
the software actively checks the status of external devices. Interrupts improve
the performance and power consumption of the embedded computer because
less operations are required from the processor.
Parallel Ports: a parallel port, or General Purpose Input and Output
(GPIO), is an input output communication interface that allows the embed-
ded computer to exchange digital information with the external world. The
pins that come out of the microcontroller board are mapped to GPIO. Pins
(or pin headers) provide electrical contact with the GPIO. A pinout is a visual
map of the microcontroller pins to their functions. Functions include digital
I/O, analog I/O and Pulse Width Modulation (PWM) (more on PWM in
Tutorial 2 — Pacing Basics). Figure 6 is a pinout of the FRDM-K64F

Developer’s Guide To Pacemaker Development 8

microcontroller. The K64F has 16 digital pins and 6 analog pins. The digital
pins are prefixed with a “D”, whereas the analog pins are prefixed with an
“A”.

Figure 6: FRDM-K64F pinout.

System Application Specific Circuits: circuits designed for a particular
application.
Other Peripherals: the K64F is also manufactured with an on-board ac-
celerometer — a device that measures the acceleration of a moving entity.
In the context of the pacemaker system, the on-board accelerometer provides
an indication of a person’s physical activity level.
I/O Interfacing/Driver Circuits: a driver circuit controls other electric
components or circuits, and is usually connected to GPIO pins. The driver cir-
cuit you will be using for the pacemaker system is called the pacemaker shield.
The pacemaker shield is a printed circuit board (PCB) that is mounted
on the K64F. A PCB is a self-contained electrical circuit with components
and conductors contained within the same mechanical structure. More infor-
mation on the pacemaker shield can be found in the document “pacemaker-
shield-explained” on Avenue.

Rev. 1.0 Tutorial 1.1: Pacemaker Project Overview 9

Summary — Pacemaker System Description
In addition to understanding the pacemaker as an embedded system, a pace-
maker is, to a certain extent, a control system because it manages, com-
mands, directs and regulates the behaviour of another system — the Cardiac
Conduction System. The pacemaker is a real-time system because it is sub-
ject to hard real time constraints. Lastly, the pacemaker is a safety-critical
system because it has the potential of harming human beings.
There we have it! Altogether, a pacemaker is a safety-critical, real-time control
embedded system.

Developer’s Guide To Pacemaker Development 10

1.2 The Project
Vision Improve familiarity with model-driven development and apply prin-
ciples of software design.

Goal Design and implement system that operates a cardiac pacemaker under
the specified modes.

Scope Design and implement the embedded pacemaker software, and the
driver software and user interface for the DCM. You are also required to verify
and document your software.

Deliverables
• MATLAB Simulink® model implementing the pacemaker operating modes
• DCM software
• Technical Documentation
• Live demonstration

Development Paradigm
A model-driven development (MDD) paradigm will be used develop the
pacemaker software. MDD “uses models as the primary artifact in the de-
velopment process” (definition from: IGI Global). MDD is important in em-
bedded systems because it reduces development time, improves collaborative
development, leads to increased software quality and reliability, and produces
software that is less error prone when compared to traditional design processes.
MDD is prominent in embedded system development across many industries
today.

About the Pacemaker System Requirements Specification (SRS)

Assignments for the lab project are based on the Pacemaker SRS. The Pace-
maker SRS is an industry standard requirements document published by Boston
Scientific in 2007. The SRS was used in a certification challenge problem issued
by the Software Certification Consortium (SCC) called the Pacemaker Formal
Methods Challenge to create certifiably safe, secure and dependable software
for the pacemaker safety critical system. Formal methods involves using
mathematical techniques when specifying, developing and verifying software,
and emphasizes correctness and proof as a measure system integrity.

Rev. 1.0 Tutorial 1.1: Pacemaker Project Overview 11

2 Tutorial: Getting Familiar with
the Project Requirements
1. Form your team.
2. Review theory on the Cardiac Conduction System and pacemakers (This
will help you understand the requirements).
3. Review the Assignment 1 outline and corresponding sections in the
PACEMAKER SRS document. Ask your TA if you have any questions.

Developer’s Guide To Pacemaker Development 12