See discussions, stats, and author profiles for this publication at: https://www.researchgate.

net/publication/247915242

Example for mobile ECG holter design using FMEA model

Article  in  Biomedical Engineering Applications Basis and Communications · February 2009

DOI: 10.4015/S101623720900109X

CITATIONS READS

3 944

3 authors, including:

Ren-Guey Lee
National Taipei University of Technology
83 PUBLICATIONS   1,618 CITATIONS   

SEE PROFILE

All content following this page was uploaded by Ren-Guey Lee on 15 January 2015.

The user has requested enhancement of the downloaded file.

January 29, 2009 17:24 00109

Biomedical Engineering: Applications, Basis and Communications, Vol. 21, No. 1 (2009) 61–70

EXAMPLE FOR MOBILE ECG HOLTER DESIGN

USING FMEA MODEL

I-Chi Chou, Hsu-Chin Hsueh and Ren-Guey Lee∗

Department of Electronic Engineering
National Taipei University of Technology
Taipei, Taiwan
∗evans@ntut.edu.tw

Accepted 15 October 2008

ABSTRACT
This paper describes an approach for evaluating the risk of components used in the Holter. Holter is a
portable device for recording patients’ electrocardiogram in medicine. Holter might hurt users as a result of
a bad design, and might record incorrectly when malfunction happens. To prevent risk of injury, we analyze
the potential failures of the Holter based on the Failure Mode and Effects Analysis, which is a risk assessment
technique. Then, we calculate the Risk Priority Number (RPN) of each failure. According to the RPN, we
give two strategies for reducing the risk. One is protection, and the other is alarm. The protection system is
used to prevent hazards of the Holter from incorrect operations by the user, and the alarm system is used to
detect the malfunction of the Holter. The experimental results show that the safety of the Holter is improved
with these two circuits.

Keywords: Holter; Electrocardiogram (ECG); Failure Mode and Effects Analysis (FMEA); Risk Priority
Number (RPN).

INTRODUCTION via general packet radio service (GPRS) to a back-

A Holter, in biomedical engineering, is a portable device
for continuously monitoring the electrical activity of the
heart, or called electrocardiogram (ECG), for 24 hours
or longer. The Holter detects ECG signals, converts the
analog signals to digital data, and stores the data into
the memory on it. Recently, the major advances in the
field of Holter record lead to the developments of tech-
nology and communication. To increase the recording
time, an external storage was utilized to record long-
term ECG signals.1,2 Some Holters can transmit ECG
data by infrared to a mobile phone that automatically
pass the ECG to a service center.3,4 The novel sys-
tem provides a vital sign monitoring system based on
a body area network (BAN) and a mobile-health ser-
vice platform that can transmit sensor measurements
end system, where a remote detection of emergencies
is performed.5,6 The Holter then makes the processing
of the signal and send the digital data via Bluetooth
or Zigbee to a remote acquisition system or monitor.
Additional features like global system for mobile com-
munication (GSM)/GPRS transmission to an analyzing
unit are also being developed. On the other hand, some
systems utilize the global positioning system (GPS) ser-
vice to locate the position of patient.7 Using Holters,
users face two kinds of risk. One is malfunction of the
Holter. In this case, the Holter cannot detect, record or
transmit correct ECG signals and results in time-waste.
The other is malfunction of the power management sys-
tem including batteries. When this hazard happens, the
user may get hurt badly.

∗
Corresponding author: Professor Ren-Guey Lee, Department of Electronic Engineering, National Taipei University of
Technology, Taipei, Taiwan. Tel.: +886-2-2771-2171 ext. 2254; Fax: +886-2-2731-7120. E-mail: evans@ntut.edu.tw

61
 January 29, 2009 17:24 00109

62 I.-C. Chou, H.-C. Hsueh & R.-G. Lee

The medical device report (MDR) of the food Electrode Instrumentation

connector Filter
and drug administration (FDA) receives approximately /Cable amplifier

100,000 submissions for agency review from medical Electrode

connector Driven Circuit
device and radiological product manufacturers each /Cable

year. FDA publishes the MDR when a device may cause

to a death or serious injury, or when a similar device Memory MCU ADC

malfunction would likely cause to a death or serious

injury. Currently, 33% of the adverse event reports to
the FDA on medical device come from user-errors and
44% from device failures or design issues. For this rea-
son, it is important to assess the risk and give the nec-
essary protection to the medical devices in advance.
There are several public standards to regular the
safety, performance, and some essential requirements
for medical devices. One of the requirements is given
by the standard IEC60601-2-47,8 which covers ambu-
latory ECG systems. The IEC 60601-1:2005,9 the 3rd
edition of IEC 60601-1, is the international standard
for basic safety and essential performance of electri-
cal medical equipments. This paper analyzes the risk
of Holter according to these standards. The Failure
Mode and Effects Analysis (FMEA) method is utilized
to assess the risk of Holter. FMEA is a risk assessment
technique for systematically identifying potential fail-
ures in a system or a process. It is necessary to clarify
the component, process, and applications of a system
before an FMEA analysis can be done. The remainder
of this paper is organized as follows. The FMEA and the
hardware architecture of Holter are described in Sec. 2.
Then, we explain the analytic process for FMEA and
propose the corresponding strategies for reducing the
risk in Sec. 3. The detailed design rules of protection cir-
cuit and alarm system are described in Sec. 4. Section 5
contains the implementation of the proposed system.
Experimental results are reported in Sec. 6. Finally,
some discussions and conclusions are given in Sec. 7.
MATERIAL
Architecture of Holter
We begin with a discussion of the architecture of a mod-
ern Holter described in Ref. 10. The Holter is portable
and battery driven with wireless/wired communication
interface, LCD display and external memory module.
As shown in Fig. 1, the Holter provides the following
features:
(1) Electrode/Cable : The Ag/AgCl electrodes and
shield cables are used.
(2) Connector : There are two kinds of connectors in
this system, which include electrode connectors
and communication connectors.
Communication
Display Power
Interface
Communication
Module Buzzer Event Button
Fig. 1 Architecture of the Holder.
(3) Instrumentation Amplifier and Right-leg Driven :
The instrumentation amplifier can achieve a high
common-mode rejection ratio and high input
impedance and decrease the loading effect and
noise interference. The driven common elec-
trode is used to reject common-mode interfering
signals.
(4) Filter Amplifier : The filter amplifier is used to
reduce power-line noise, baseline wander and other
system noise.
(5) Micro-Controller Unit (MCU) : MCU is the core
unit of Holter, it records the user’s ECG signals,
detects events, sends alert messages, and so on.
(6) Analog to Digital Converter (ADC) : It converts
the analog signal to digital data and decides the
quality and capacity of signals.
(7) Memory Module : The capacity of the built-in
memory in the MCU is very limited. Hence, the
Holter provides an external memory module whose
size depends on the sampling rate, the resolution
and recording time.
(8) Display Module : The LCD displays the ECG
waveform in real time and shows the status of the
Holter.
(9) Buzzer : Buzzer can sound the alarm for events.
(10) Event Button : When a patient feels a symptom
(such as dizziness or chest pain), he/she can push
the button to mark the ECG signal.
(11) Communication Module : This Holter supports
RS232C and USB interfaces for connecting with
Bluetooth, GSM or GPS modules.
(12) Power Module : The power module contains a
power button, a battery module, a charger and
a power management circuit.
The risk of the major components will be analyzed
by using the FMEA technique discussed in the following
section.

View publication stats