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Abstract— Electromagnetic compatibility (EMC) – the ability of As in many other fields, the amount and complexity of
electronic systems and devices to function well in close proximity electronics in hospitals and other medical environments is
of one to another – is an important item to be considered in the increasing year by year. Despite this, the number of reported
design and construction of healthcare facilities. Hospitals contain incidents of EMC problems fortunately does not appear to be
a large variety of equipment, such as electro-surgery units that growing. This is probably because most manufacturers and
are known to produce high levels of electromagnetic interferences
designers of medical electronic products have developed a
(EMI) and other devices such as ECG (Electrocardiography) and
EEG (Electroencephalography) , which are known to be good awareness of EMC.
particularly sensitive to electromagnetic disturbances. Despite With respect to the legislation in place, electro-medical
the existence of standards and regulations, there is often no equipment carries the CE marking demonstrating compliance
collaboration between the designers of the buildings and the with the Medical Devices Directive (MDD) [3], the Active
users of the equipment therein. In this paper, we show how an Implantable Medical Devices Directive (AIMD) [4] or the In
understanding of EMC enables us to prevent interference Vitro Diagnostic Medical Directive. The compliance is in
problems and protect critical systems. We discuss about most cases demonstrated by meeting the requirements of EN
installation and maintenance practices such as the use of zoning 60601-1-2 or EN 55011 in the case of Industrial, Scientific
and safe distances, aiming to ensure that adequate levels of EMI
and Medical (ISM) equipment.
are achieved in the hospital environment.
In our paper are presented results of measurements upon the In terms of Romanian legislation, there is law no.
electromagnetic field in an intensive therapy room, while 176/2000 of the Medical Devices, amended in 2005, that
observing the influences of the electromagnetic field generated by defines medical devices and equipment, specifying that any
an external source (GSM phone) on the functionality of medical electro-medical equipment with the CE mark can be used in
devices in the lounge. We created a map of the electromagnetic hospitals. This law does not set out anything about the
field and we proposed solutions to reduce the influence of EMI on emission of electromagnetic radiation allowed on medical
medical devices. device or the values of the electromagnetic field affecting or
damaging the equipment.
Keywords - Intensive therapy room, electromagnetic
There is an European standard workable to medical
interferences , mobile phone interferences. equipment. This is STD EN60601-1-2, defining the emission
limits and immunity to electromagnetic radiations of medical
equipment, medical electrical systems and ICT equipment
I. INTRODUCTION used in hospitals. This standard specifies the minimum limit of
immunity to electromagnetic field of medical equipment to be
3V / m.[ 5]
Although electromagnetic interferences in hospitals are EMC should also be an integral part of the design process
often regarded as no more than a minor nuisance, there are when planning for the construction of healthcare facilities: the
documented cases in which equipment failures due to electrical internal power wiring of hospitals can be quite
electromagnetic interference (EMI) have lead to personal varied and complex and it is important to ensure that the
injury or even death. Some examples follow: power line does not provide a path to propagate EMI
• In 1992, a patient attached to a monitor-defibrillator throughout the building. The use of many electronic devices in
in an ambulance died because interference from the close proximity of the hospital environment means that the
ambulance radio prevented the machine from general EMC difficulties could be here also encountered.
working [1].
• In 1993, a patient fitted with a pacemaker went into
ventricular fibrillation shortly after being scanned
with a metal detector outside a courtroom [2].
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Radiation telecoil option or ‘T-switch’ [11] .This enables the aid to pick
For frequencies above about 30 MHz, radiation tends to be up magnetic fields from telephones and also from specially
the dominant propagation mechanism. There are two types of fitted induction loops in meeting halls, churches etc.
radiating emitters: intentional and unintentional. Intentional Unfortunately this system is susceptible to low frequency
emitters, such as radio and radar, produce spurious emissions radiation fields from motor drives, telecommunications cables
together with their intended signal. These may be in the form and computer monitors, which are not covered by EMC
of harmonics or inter-modulation products of the intended standards because they are below 150 kHz.
signal and are directly associated with the primary function of Physiological-monitoring equipment is vulnerable to pulsed
the equipment. Practical radio transmitters also radiate RF, which can be demodulated by non-linear elements in
broadband noise. Unintentional emitters, for example personal amplifier circuits. Some monitors are connected directly to the
computers or thyristor drives, generate emissions as a by- patient in order to detect small physiological signals, as shown
product of the primary function of the equipment. [7] in the following table:
Measurements Typical
IV. SOURCES OF EMI voltage
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hands with electric photocell, a console with electrical outlets
and sources of oxygen, medical air and vacuum. On this map we observe that the highest electromagnetic
For the measurement of electromagnetic field we used a field values are in the area with medical devices all turned on.
smart Field Meter with the following features: The EM field strength was measured and mapped around
electrical devices in a two beds neonatal ICR furnished with
Meter, Probe Frequency Field Strength Range standard equipment (ventilator, monitor, infusion pumps,
response heated airbed, humidifier). The overall flux density in the
Smart 50 KHz - 18 0.2-800 V/m (depending on the patient area was assessed by measuring the field intensity at
Fieldmeter® GHz probe) the patient's head during one hour.
Digital Meter: (depending on
Model: RFP- the probe).
05 VII. ELECTROMAGNETIC INTERFERENCES ON
Probe: PI-03 3 MHz - 18 GHz 0.8 – 800 V/m MEDICAL DEVICES
Probe: PI-02 2 MHz - 12.5 0.5 – 800 V/m
GHz
The second study was to observe the influence of mobile
Probe: PI-01 0.2 MHz - 3 GHz 0.2 – 600 V/m phone use on medical equipment operating parameters in an
Probe: PI- 900-1900 MHz. 0.4 – 400 V/m intensive care room and to measure the electromagnetic field
01V Dual GSM band. produced by them.
Probe PI-01 50 KHz – 3 GHz Measurements were made in the same Intensive Care Unit,
(LF Option) in a room without patients to not influence their condition.
These measurements were subject to medical devices:
All medical devices subject study were mounted and set
for operation in the same way as they were connected to a 1. Infusion Pump B / Braun.
patient. We tried to identify areas with the highest value of the 2. Acutronic Fabian conventional ventilation type
electromagnetic field, when all the medical devices were 3. Dash 2500 Vital care Monitor
turned on. 4. Isolette Incubator type C-2000
5. EEG brain monitor type BRAINTZ 3
2. Measurements and Results .
The purpose of these measurements is to identify areas 1. EMC testing protocol for medical devices
where the most powerful electromagnetic field in room. The Medical devices were not connected to patient. The
room was divided in approximately symmetrical points were protocol proceeds as follows:
measurements were performed. We have to mention that the 9 We set up the device to represent a normal working
device used to measure electromagnetic field computes the mode (clinically sensible parameters including
average . alarms). We prepared a simple but repeatable mean
After the measurements we obtained a map of the points of of accurately measuring the distance between the
maximum intensity for the electromagnetic field. device and the phone unit. We ensured that the phone
batteries are fully charged before starting the tests.
9 Previous to our testing, we recorded the type of
device, manufacturer, model and serial number using
a test results sheet drafted by us.
9 We started the EMC test at the front main surface
(not quite touching) of the device, the ‘near field’
case. We dialled the free phone number supplied to
us with the phone. During dialling and initial
communication, the digital phone systems will be
operating at maximum transmitted power. We’ve
noted any effects observed on the test result sheet.
For an observed effect we determined the distance
over witch the effect occurs. We examined the device
settings and noted before the start of the test to
determine any alterations.
9 We repeated the above test at a distance of 0.5 meters
and one meter.
2. Test results
We obtained the following test results, for each type of
Fig.2 The EMF values obtained in 10 measured points. medical device:
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1. The infusion pumps type B / Braun measurements value of that safety distance may be variable and depends on
were made for four devices simultaneously with the several factors:
series number SN: 83033, 83040, 83018 and 83044.
Test phone closed and in standby mode was done 1. type of equipment,
with two preset values of volume infused: minimum 2. orientation of equipment,
value of 0.1 ml / h and a maximum of 99 ml / h. It 3. equipment over- crowding
was staged infusion syringe containing 50 ml glucose 4. available space in every bed space.
5%. In phone call mode, preset volume infused was The magnetic flux density should be monitored regularly in
99 ml / h, which is the highest. Conclusions of the every ICU for the specific design of each unit.
tests: we noticed changes in the rate of infusion, three Hospitals will need to formulate local policies, based on
of four devices at a maximum volume administrated, the medical devices in use, the communications equipment
variations ranging from 0.45 ml and 1.20 ml. and the local environment.
EMC is a concern not just for manufacturers, but also for
2. Ventilator type Fabian Plus Serial Number: 02-0404 those who install, use, modify or maintain medical equipment.
fitted with test lung (for a better patient connection The existence of directives and standards has encouraged good
simulation), in ventilation IPPV mode, set the EMC design practices, but should not be relied on to prevent
following parameters: FiO2 = 21%, respiratory rate EMI problems owing to the nature of the hospital EM
(Resp) = 16 beat / min, inspiratory pressure (PIP) = environment.
18 , expiratory pressure (PEEP) = 5 and a Tidal Much more can be done by promoting awareness of EMI,
Volume = 500 ml. Conclusions of the tests: there also underlying coupling mechanisms. Many potential
were changes in Tidal Volume with a variation problems can be solved by ensuring adequate separation of
between 35 ml and 54 ml, depending on the distance sources and victims of interferences: for example by placing
from the source. SW diathermy or electro-surgery in a different part of the
building than EEG and other sensitive equipment, by
3. Cardiomonitor (Vital Functions Parameters Monitor) implementing reasonable restrictions on mobile phones and by
Dash 2500 which has attached an oxygen saturation avoiding crosstalk problems when installing mains and data
sensor SpO2 and ECG electrodes. Were preset alarm cables.
limits and I lead set it in EKG. Conclusions of the At this time we can not forbid to use a cell-phone in any
tests: no major changes were observed in ECG signal. Romanian Hospital, but the cell-phone should always be
switched off in the following locations:
4. Neonatal Isolette Incubator type C-2000 SN: 9 Operating theatres and treatment areas were sensitive
TW12218 and QT17756 with air temperature set at devices may be used.
33 ° C and humidity set at 40%. Conclusions of the
tests: small deviations were observed in 2% -5% 9 In the patients’ neighbourhood, mainly when the
humidity and air temperature inside the incubator. patient is connected to any electro-medical device.
The normal inside the Incubator temperature that
baby needs is 33° C, so he maintains a body 9 Other designed areas where could be a perceived risk.
temperature of 36.5° C. If the incubator temperature
has a variation of 2 to 5 degrees, correlated with a It is important that users, patients and visitors to be
humidity variation, the baby's body temperature informed about these restrictions; restricted areas must be
changes significantly. For a newborn infant, a 0.5 clearly signed; staff should be aware of the possibility of
degree variation might be significant. affecting medical devices due to EMI from mobile phones.
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[7] Tim Williams, EMC for Product Designers (Second Edition), [11] Robert Higginson, ‘Are you hearing me? An aid for the disabled
Newnes, Oxford, ISBN 0 7506 2466 3. lacking EMC protection’, UK EMC Journal p. 14, June 1998.
[8] J Gardner, ‘Practical problems of electrosurgery’, IEE Colloq. [12] I D Flintoft, M P Robinson, S J Porter and A C Marvin 2000.
on ‘Electromagnetic interference in hospitals’, Digest no. ‘Addressing the risks of EMC problems with mobile radio
1994/190, sec. 6, 1994. transmitters’ Compliance Eng. 17, Sept./Oct. pp 30-38.
[9] Robert Nelson and Hualiang Ji, ‘Electric field strengths created [13] R Railton, G D Currie, G A Corner and A L Evans,
by electrosurgical units’, IEEE Int. Symp. EMC, p. 366, 1994. ‘Malfunction of medical equipment as a result of mains borne
[10] Medical Devices Agency, ‘Emergency service radios and mobile interference’, 8th Int. Conf. EMC, Edinburgh, UK, p49, 1992.
data terminals: compatibility problems with medical devices’,
MDA DB1999(02), 1999.
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