MS-2160: Mitigation Strategies for ECG Design Challenges

MS-2160: Mitigation Strategies for ECG Design Challenges
Technical Article
MS-2160
.
Mitigation Strategies for ECG
Design Challenges
by Bill Crone, Systems Engineer, Healthcare
Analog Devices, Inc.
[email protected]
IDEA IN BRIEF
Engineers can use Analog Devices solutions to manage the
major challenges of electrocardiogram subsystem design,
including safety, common-/differential-mode interference,
input dynamic range requirements, device reliability and
protection, noise reduction, and EMC/RFI considerations.
An electrocardiogram (ECG) is a common medical recording
that must be readable and accurate in many harsh environments. Whether in a hospital, ambulance, aircraft, marine
vehicle, clinic or home, sources of interference are pervasive.
A new wave of highly portable ECG technology has made it
possible to measure the heart’s electrical activity in a larger
variety of settings. As ECG subsystems make their way into
more out-of-hospital applications, manufacturers face continued pressure to reduce system cost and development time
while maintaining or increasing performance levels. The
resulting demands on ECG design engineers are considerable:
provide a safe and effective ECG subsystem that can withstand the challenges of the intended use environment.
This paper identifies what are typically considered the major
challenges of ECG subsystem design and recommends various
methodologies with which to mitigate them. The challenges
that are discussed are safety, common-/differential-mode
interference, input dynamic range requirements, device
reliability and protection, noise reduction, and EMC/RFI
considerations.
CHALLENGE #1: MEETING THE HIGHEST LEVEL OF
SAFETY TO ENSURE THAT THE ECG SUBSYSTEM IS
SAFE AND EFFECTIVE
Safety is always the number one design concern of the ECG
designer. Both the patient and the operator must be protected from power surges or overvoltage coming from the ac
mains and from any current path through the ECG electrodes
that could exceed the recommended limit of 10 µA rms. The
ultimate goal is to ensure patient and operator safety from
dangerous voltages or currents that can occur should there
be a fault condition in the ECG subsystem itself or in some
other medical device attached to the patient or operator.
Figure 1. Overview of AC Mains Coupling
Prior to the start of the ECG design, engineers must determine
the clinical applications, as well as where the device is to be
used and stored. Engineers must evaluate all possible misuse
of the device and potential external connections that could
result in currents applied to the patient. Safety for the operator
and patient can be maintained when the applied current (sink
or source) is limited to less than 10 µA rms, even during
single-fault failures. The patient must be protected from
accidental electric shock, and the ECG apparatus must be
protected from extreme voltages generated by emergency
use of a cardiac defibrillator.
ECG systems must meet federal regulations as well as international standards and individual country directives. In the
U.S., the Food and Drug Administration (FDA) classifies
medical products as Class I, Class II, or Class III. These
classification categories impact product design and the
approval process. For instance, a portable Holter monitor for
diagnosing cardiac rhythms is considered a Class II device.
In contrast, a cardiac monitor/defibrillator with an ECG
subsystem is designated Class III.
What is the significance of a device classification? On its
Device Classification web page, the FDA states
April 2011 | Page 1 of 6
The class to which your device is assigned determines,
among other things, the type of premarketing submission/
application required for FDA clearance to market. If
your device is classified as Class I or II, and if it is not
exempt, a 510k will be required for marketing. All
devices classified as exempt are subject to the limitations
on exemptions. Limitations of device exemptions are
covered under 21 CF xxx.9, where xxx refers to
www.analog.com
©2011 Analog Devices, Inc. All rights reserved.
MS-2160
Technical Article
Parts 862-892. For Class III devices, a premarket
approval application (PMA) will be required unless your
device is a preamendments device (on the market prior
to the passage of the medical device amendments in
1976, or substantially equivalent to such a device) and
PMA’s have not been called for. In that case, a 510k will
be the route to market.
Device classification depends on the intended use of the
device and also upon indications for use.
Each medical device has a classification/rating of Type B,
Type BF, or Type CF. These classifications affect how the
device is designed and used. Different leakage current limits
and safety testing apply per IEC60601-1. The IEC standard
also defines an applied part as the part of the medical device
that comes into physical contact with the patient in order for
the device to carry out its intended function.
Most medical devices are classified as Type BF or Type CF.
Type BF devices have conductive contact with the patient
but not the heart. Type CF is reserved for devices and parts
directly contacting the heart. ECG designers are advised to
approach every ECG application as a type CF Class III
system. The designer has no control over how the ECG
subsystem is applied to a patient and, if the patient has an
access point to the heart, the device must be classified as
Class III due to the potential direct connection of an applied
part to the heart. All cardiac-monitor/defibrillators are
classified as Class III devices.
The human heart is most sensitive to electric current in the
50 Hz to 60 Hz range. As little as 34 µA rms at 50 Hz/60 Hz
traveling through the heart has been shown to compromise
the heart and cause a life threatening event. Given various
procedures that can occur while an ECG system is attached
to a patient, including indwelling catheters for pacemakers/
AICDs (automatic implantable cardioverter-defibrillators),
the present limit of current permitted at 50 Hz/60 Hz is set
to 10 µA rms. In ECG design, a limit of 10 µA rms with no
fault conditions is the design parameter. The American
College of Cardiologists (ACC) also recommends that the
limit of 10 µA rms extend to single-fault failures as well.
The designer must examine all scenarios where current
between electrodes, or from electrodes to the circuitry or to
earth ground, could create single-fault scenarios where the
current can exceed 10 µA rms. This source/sink current is a
function of frequency, but the 10 µA rms limit ranges in
frequency from dc to 1 kHz. From 1 kHz to 100 kHz, the
current level linearly increases with frequency: from 10 µA
rms at 1 kHz to 1 mA rms at 100 kHz. Above 100 kHz, the
current is limited to 1 mA rms.
Solutions come in the form of resistance placed in the signal
path and/or current-limiting devices. Analog Devices manufactures components that can assist in addressing the needs
for patient safety.
CHALLENGE #2: COMMON-MODE AND DIFFERENTIAL-MODE ENVIRONMENTAL SIGNALS AND
RADIO FREQUENCY INTERFERENCE (RFI)
An ECG measures the voltage generated by the heart’s electrical system. At the same time, the ECG subsystem must
reject environmental electrical signals, such as ac mains,
security systems, and radio frequency interference (RFI) to
amplify and display the ECG signal. Common-mode voltage
does not provide any useful information about the heart and
may actually impede measurement accuracy. The ECG
system must be able to reject common-mode interference,
while responding to the signal of interest—the differentialmode ECG voltage. The ability to reject large commonmode signals in the presence of a small differential signal
relates to the common-mode rejection (CMR) of the system.
Common-mode rejection can be measured many ways. In
this paper, two methods are discussed. The first is to tie all of
the ECG electrodes together and drive the electrodes relative
to the ECG analog front-end voltage reference. For singlesupply operation, the reference may take the form of a
virtual voltage driven from the RLD electrode that places the
level at half the distance between the unipolar supply and
isolated ground. The common-mode rejection in this case is
the resultant output level relative to the input level (20×log
(VOUT/VIN)). VIN is the common-mode voltage applied, and
VOUT is the voltage that appears at the particular lead of
interest. To see the common-mode rejection of Lead II, the
voltage is applied to all electrode inputs relative to the right
leg drive terminal (if this represents the midpoint of the
ADC or the RLD reference) and the device is programmed
to display Lead II. The voltage appearing at Lead II is VOUT,
the applied voltage, VIN.
Another method of measuring common-mode rejection is to
tie all the electrodes together and drive them relative to earth
ground. Again, the definition of the common-mode rejection is
20×log (VOUT/VIN), where VIN is the common-mode drive
signal and VOUT is the signal seen on the particular lead of
interest.
This part of the subsystem design and components selection
requires modeling the human subject, the environmental
coupling of the ac mains and incoming RFI into and through
the patient, and the subsequent impact on the performance
of the ECG amplifier as it attempts to reject the incoming
common-mode signals. Incoming RFI is removed by
April 2011 | Page 2 of 6
www.analog.com
©2011 Analog Devices, Inc. All rights reserved.
Technical Article
MS-2160
multiple methods, including differential- and commonmode filtering, environmental shielding, and algorithms.
Figure 2 shows a traditional high frequency, low pass filter
network, which is prone to differences in C1A, C1B, and C2
values. Figure 3 shows an integrated X2Y capacitor
implementation that offers higher performance due to the
nature of the X2Y construction and design.
mains as well as other external inference sources, such as
equipment powering on/off and radio-frequency transmission sources. The common-mode rejection must be as
good with zero offset on the inputs of the differential
amplifier as it is with a differential input voltage as high as
±1 V.
Other solutions to power-line interference include DSP
techniques such as subtraction algorithms. To assist the
designer, Analog Devices offers components that reduce the
impact of large incoming common-mode signals: CMR INA
amplifiers, PLLs, converters, and synchronous modulators/
demodulators for lock-in amplifier systems. The ADAS1000
ECG AFE addresses common-mode rejection by featuring
high differential input impedance and RLD.
CHALLENGE #3: ANALOG FRONT-END COMMONMODE AND DIFFERENTIAL-MODE DYNAMIC
RANGE
Figure 2. Traditional High Frequency, Low Pass Filter Network
Figure 3. Integrated X2Y Capacitor Implementation
Dedicated ECG designers should model the potential
environment to determine not only the ac power mains
common-mode signal but also other common-mode and
differential-mode signals that may arrive at the ECG
electrodes when attached to the patient. Most ECG cables
have protection resistors embedded in them for defibrillator
protection. This impact, along with differences in cable
capacitance and front-end EMI filtering, can cause the
common-mode signal to become unbalanced, resulting in
phase shifts and common-mode to differential-mode
conversion.
A technique called right leg drive (RLD) can reduce the
CMR requirements of multiple-lead configurations. The
common-mode voltage seen by the amplifier relative to
earth ground can be reduced even in a 2-lead system by
using a form of RLD that drives current back into the
electrodes 180 degrees out of phase with the incoming CM
signal. Because the electrode impedances are not matched,
the current injection must account for this, adjusting the
relative current/phase to minimize the effective commonmode signal.
In short, the amplifier input must have large enough
common-mode (CM) and differential-mode (DM) signal
ranges to accommodate arriving CM/DM signals from ac
ECG devices must be able to react quickly when a patient is
shocked with a defibrillator. A physician may need to see the
patient’s electrocardiogram within one second after
defibrillation. If this pulse is applied through certain types of
metal such as stainless steel, the post defibrillation polarization of the material may be as high as 0.7 volts after 1 second.
This differential offset, along with potential electromagnetic
(EMI) and/or radio frequency interference (RFI ), can
exceed the input range of the ECG front end. In short, the
amplifier saturates and the ECG signal cannot be seen.
The ECG design must be able to maintain its common-mode
and differential input performance even during this type of
transient input. Because most ECG systems are now sold
worldwide, designers must also address the worst-case ac
mains input range. Case in point: in west Australia, the ac
mains voltage can be as high as 264 VAC rms with 6 kV
spikes. The common-mode rejection in this environment
must be a factor of approximately two times higher than in
the United States where the ac mains voltage is 120 VAC
rms. This fact, along with the electrode offsets and polarization that can occur, require high differential and commonmode input dynamic range. Because the ECG voltage is
between 100 µV and 3 mV peak to peak, the dynamic range
input capability of the analog front end prior to digitization
of the signal of interest is significant. Modern day ECG front
ends have dynamic input ranges that are approximately ±1 V
for Ag/Ag-Cl electrode applications to ±1.5 V or higher for
defibrillator pad applications.
Some systems operate off a single supply voltage with a
generated virtual ground that applies a midpoint voltage to
the patient (no current) halfway between the supply ground
and the supply rail. This is typically part of the RLD
April 2011 | Page 3 of 6
www.analog.com
©2011 Analog Devices, Inc. All rights reserved.
MS-2160
Technical Article
circuitry. The electrode amplifiers are relative to this midsupply rail to insure no injection of ac or dc current. The
required input dynamic range of ±1 V relative to this virtual
ground is what is required for rapid response post
defibrillation and anticipated worst-case environmental
conditions.
Figure 4. Right Leg Drive—Possible External Component Configuration
The noise performance, linearity, CMRR, and differential
gain of the ECG front end must not be compromised by the
particular input operating point of the amplifier. The input
impedance for each electrode must be greater than 1 GΩ
with capacitance of approximately 10 pF or lower, preferably
matched between electrodes. The Analog Devices discrete
AD8220 and AD8226 instrumentation amplifiers feature
wide dynamic range to enable circuit architectures that meet
CMR needs. The ADAS1000 ECG AFE meets the requirements for low noise, high dynamic range, CMR, and
linearity. Blackfin® processors also meet the back-end needs
of ECG and automated external defibrillator (AED) devices.
CHALLENGE #4: ESD, ENVIRONMENTAL, AND
DEFIBRILLATOR PROTECTION
Design engineers must protect the ECG front end from
damage. ECG systems require built-in protection circuitry to
handle electrostatic discharges, defibrillator discharges, or
other overvoltage and overcurrent events. The human hand
model, which mimics the electrostatic discharge of a human
touching a device, uses a 1500 Ω resistor and a series 100 pF
capacitor that limit the current that can be discharged through
the human hand. The charged voltage dictates the amount of
instantaneous voltage that can be applied and how the current
is limited. Voltages in excess of 18 kV are possible. Some
standards set the voltage to as low as 8 kV.
Most ECG systems have input protection for a defibrillator
pulse and ESD using the human hand model. Defibrillator
protection circuitry has multiple requirements: to maintain
the CMR of the preamplifier at performance frequencies; to
shunt less than 5% of the delivery defibrillator energy away
from the defibrillation electrodes/pads; and to fully protect
the preamplifier circuitry in such a way that the ECG can
quickly be seen on either a display or strip chart after a
defibrillator pulse. In the emergency room (ER), a onesecond delay (or shorter) is the desired response time.
The defibrillator protection circuitry can take two forms. In
one case, where the ECG cable is part of a cardiac monitor
defibrillator, a series of resistors (energy rated high voltage
resistors) typically limits the current into an ECG front end.
In addition, some protection circuits have argon or xenon
bulbs on the ECG side of the protection resistors to limit the
preamp side voltage to less than 100 V. Additionally, voltage
and current limiting devices ensure that the ECG system is
not damaged. The designer should consult with the manufacturer of the particular instrumentation amplifier (INA) or
any active/passive circuitry that can potentially see this high
voltage and current. Silicon-controlled rectifiers (SCRs)
provide some of the overvoltage protection. Energy-rated
series resistors provide current protection. Current limiters
can also be considered.
Most active devices cannot tolerate the voltages associated
with ESD testing without some form of protection. It is a
requirement to check with the active device manufacturer to
determine the degree of protection required and the suggested
mitigation. The designer is encouraged to review the FDA
guidance relating to energy-rated resistors for defibrillator
protection. Some devices have been recalled due to improper
measurement/rating of these resistors (the FDA recently
announced it is reviewing regulations for AEDs amid reports
of device malfunctions).
To aid the designer with discrete defibrillator protection
circuitry, Analog Devices components have been tested to
tolerate high levels of ESD and input current and voltage.
The ADAS1000 ECG AFE includes large ESD protection
structures on its package pins and has been evaluated for
tolerance of maximum source/sink current.
CHALLENGE #5: ELECTRICAL NOISE
ECG signals may be corrupted by multiple sources including
power-line interference, contact noise between the electrode
and the skin, motion artifacts, muscle contraction, and
electromagnetic interference from other electronic devices.
Any number of sources can cause the ECG baseline to drift
or appear electrically noisy. What’s important to clinicians is
that the ECG signal be clear and that all the electrical noise
combined be as small as possible so as to not confound the
ECG diagnosis. For diagnostic ECG applications, the noise
floor should be designed to meet 10 µV peak to peak.
April 2011 | Page 4 of 6
www.analog.com
©2011 Analog Devices, Inc. All rights reserved.
Technical Article
MS-2160
ECG designers must take steps to filter out or discard all
these noise sources. The requirements for the equivalent
input noise floor varies by application. For monitor quality
systems, such as a heart rate monitor (HRM), it is usually
adequate to specify an equivalent noise value of approximately 25 µV peak to peak over a 0.5 Hz to 40 Hz bandwidth. In some cases, to make the system extremely low
power, a higher noise floor may be allowed. Even in
monitor-quality applications, the noise floor is required to
be lower than 25 µV peak to peak, hence the need to fully
understand the clinical environment and algorithm
requirements.
When designing a fully diagnostic 12-lead ECG system (10
electrodes), the bandwidth can be as low as 0.05 Hz to 150 Hz
or as broad as 0.05 Hz to 2000 Hz. Pacer detection requirements increase the bandwidth further to at least 100 kHz.
In Holter monitors, for example, evaluation of the ST
segment of the ECG waveform is used to determine STEMI
(ST segment elevation myocardial infarction); a bandwidth
of 0.05 Hz to 40 Hz can be selected to help reduce the overall
noise floor, even at the expense of evaluating higher frequency
components beyond 40 Hz. In other monitors, the bandwidth
can be 0.05 Hz to 150 Hz or even 250 Hz depending on the
patient and the intent of the evaluation.
Other noise considerations include cable movement, which
can create low-frequency noise unless properly constructed,
and burst noise, also known as shot noise or telegraph noise.
This type of noise prevents physicians from seeing important
information at various portions of the cardiac cycle, including
the ST segment.
To manage the problem of noise, Analog Devices uses various
circuit techniques to remove the 1/f characteristic of a typical
input amplifier while still maintaining low Gaussian noise
and excellent device linearity. The Analog Devices CMOS
process lends itself to very low levels of telegraph noise.
CHALLENGES #6: ELECTROMAGNETIC
COMPATIBILITY (ECM) AND RADIO FREQUENCY
INTERFERENCE (RFI)
ECG subsystems must be protected from a variety of
external/environmental emissions. For example, nearby
medical equipment, as well as high frequency industrial or
consumer electronics in the environment can generate
sufficient E and H fields with complex modulation/transmission protocols. Interfering signals can reach the ECG
front end through conducted or radiated emissions.
Thus, early in the process, designers must consider regulatory
standards for radiated emissions, radiated susceptibility,
immunity, conducted emissions, and conducted susceptibility/
immunity. Due to atmospheric contamination throughout
the world, it is becoming increasingly hard to find an open
area test site (OATS) that allows full spectrum testing of a
unit. In some countries, usage of a full height 10 meter test
chamber is now acceptable in lieu of an OATS.
System designers must work with the EMC testing agency to
determine the levels of essential performance, as defined in
the third edition of IEC60601 and derivatives. Margin in
reading must also be defined as having a 0.1 dB margin at a
particular frequency while officially passing may not be
acceptable because there may be as much as ±4.0 dB variability in readings between OATS and 10 meter chambers at
multiple sites. Typically, an 8.4 dB margin is considered
conservative.
The designer should examine the PCB footprint for the
ECG, the digital and/or analog I/O to the remaining portion
of the system, the incoming power forms, the grounding,
and the Faraday shield, which assists in preventing radiated
emissions from being detected by protection diodes and
other circuitry embedded in the ECG design. The ECG cable
itself may have resonances at specific frequencies relating to
the cable length. In the event that one of those resonances is
energized by an internal clock or emitter inside the ECG
design, compliance to Level B of the standard may be
difficult. This is why common-mode/differential chokes and
inline ferrite may be needed on various cables.
Prior to formal testing, a designer can consider sniffing the
design with a series of E and H field probes and a spectrum
analyzer to define radiating frequencies and harmonics. A
series of prescans can determine the location of hot frequencies
and how close they come to the limit. Consulting a source list,
a designer can then determine if a Faraday shield is required
over this emitter or whether slowing of signal edges may be
adequate. Some cables inside the system may need ferrite or
other filters to quell a resonance or high-level emitter.
Another solution is to seek out highly integrated, small
packaged devices that are equipped to meet radiated emissions
and incoming radiated susceptibility. The ADAS1000 ECG
AFE meets these needs and is the first device on the market
to incorporate leads-off detection, respiration monitoring,
and pacemaker pulse detection on a single chip.
April 2011 | Page 5 of 6
www.analog.com
©2011 Analog Devices, Inc. All rights reserved.
MS-2160
Technical Article
SUMMARY
RESOURCES
Designing an ECG subsystem presents a plethora of safety
and signal processing challenges characterized by small
signals, a wide bandwidth requirement, interference from
power lines and the environment, and the desire to have a
very low noise ECG amplifier while maintaining very low
power consumption. A wealth of information exists to assist
the designer in developing safe, reliable, and high performance ECG designs. As a leader in signal-processing technologies, Analog Devices offers a wide range of solutions to help
design engineers overcome all of the major ECG challenges.
For additional information, visit www.analog.com/healthcare.
Products Mentioned in This Article
Product
AD8220
AD8221
AD8226
ADAS1000
One Technology Way • P.O. Box 9106 • Norwood, MA 02062-9106, U.S.A.
Tel: 781.329.4700 • Fax: 781.461.3113 • www.analog.com
Trademarks and registered trademarks are the property of their
respective owners.
T09837-0-4/11(0)
April 2011 | Page 6 of 6
Description
JFET Input Instrumentation Amplifier with Rail-toRail Output in MSOP Package
Precision Instrumentation Amplifier
Wide Supply Range, Rail-to-Rail Output
Instrumentation Amplifier
Low Power, 5-Electrode Electrocardiogram (ECG)
Analog Front End (AFE)
www.analog.com
©2011 Analog Devices, Inc. All rights reserved.
Was this manual useful for you? yes no
Thank you for your participation!

* Your assessment is very important for improving the work of artificial intelligence, which forms the content of this project

Download PDF

advertisement