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Abstract
The safety of biomedical devices in Nigerian hospitals is often neglected. Preventive
maintenance schedules do not have a clear program for safety testing of various devices. Use of
biomedical devices exposes patients, medical staff and visitors to electric hazards. Safety
assurance of biomedical devices is critical. After repair or during preventive maintenance
schedule, several electrical safety tests are carried out by a device called electrical safety
analyzer (ESA) to ascertain the safety of medical equipment. Many hospitals in Nigeria do not
have this device due to importation cost. The poor state of Nigeria economy imposes restriction
on importation and favors indigenous development of goods and services. The design of a
portable and affordable electrical safety analyzer is presented to improve safety of biomedical
devices and healthcare delivery in Nigerian hospitals. The constructed electrical safety analyzer
presents acceptable accuracy. The accuracy of the locally constructed electrical safety analyzer
compared with an existing imported electrical safety analyzer is found to be approximately
2.22% which is within the tolerance limit specified by the United State Food and Drug
Administration (FDA).
devices are essential (Brown and Carr, 1981; IAEA, 2000; Ortiz-Posadas and Vernet-
Saavedra, 2006; Zubair, 2010). Use of biomedical devices exposes patients, medical
staff and visitors to electric hazards. Biomedical devices are meant to improve patient
health care and the quality of life of individuals. Carelessness may make biomedical
devices to do the opposite. Therefore, safety of biomedical devices is very critical. The
use of a biomedical device should be free of adverse effects and should not lead to
injury or death of patients and hospital staff. Therefore, safety of biomedical devices
is very critical (Angelakis et al., 2014; Chakrabartty and Panda, 2010). Electrical safety
is the containment or limitation of hazardous electrical shock, explosion, fire or
damage to equipment and buildings (Albert et al., 2014; IAEA, 2000; Ortiz-Posadas
and Vernet-Saavedra, 2006; Zubair, 2010).
After repair or during preventive maintenance schedule, several electrical tests
are carried out to ascertain the safety of medical equipment. These tests are termed
electrical safety tests. An instrument for these tests is termed electrical safety analyzer
(ESA). Electrical safety tests include visual inspection, measurement of line voltage,
ground resistance, device current, ground leakage current, chassis leakage current,
lead to ground leakage current and lead to lead leakage current. Lead refers to cables
that come in contact with patient body like ECG leads (Angelakis et al., 2014; Beckes,
2007; Cadick et al., 2006; Fadhl, 2013; Feinberg and Feinberg, 2001; Fluke, 2008;
Geojy, 2002; Park, 2014; Taktak and Brown, 2006; Wilkins, 2008; Zubair, 2010).
The safety of biomedical devices in Nigerian hospitals is often neglected. It is
the same story in many other African countries. Preventive maintenance schedules do
not have a clear cut program for safety testing of various devices. Deterioration such
as insulation breakdown and weakening of connection of device to ground begins as
soon as new equipment is installed. It can be accelerated by factors such as
environment, changing voltage conditions, severe duty cycles or overload. Healthcare
personnel and patients are therefore at risk usually due to electrical shock from
devices whose safety measures have been compromised (Zubair, 2010).
An effective electrical safety preventive maintenance program can reduce
accidents, save lives, and minimize costly breakdowns and unplanned shutdowns of
health care equipment. Failures can be averted by identifying and correcting
impending troubles before they become major problems requiring more expensive
and time consuming solutions (Cadick et al., 2006). A stich in time saves nine.
There are few trained biomedical devices maintenance technicians in Nigeria.
Only few of them in few teaching hospitals in some urban cities have access to
essential maintenance tools like electrical safety analyzers. Electrical safety analyzers
like other biomedical devices are imported to the country at very high prices and are
only available in just some of the major cities. Patients have to travel to the major
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Abdul R. Zubair, Olajide J. Odelanu, Obinna M. Ibe, Akinwale O. Coker, Academic and Applied Studies Vol.6 (Q.2), 2016, 1-19
cities to benefit from such devices. Most private, non-governmental and government-
owned establishments cannot afford the high costs.
The Nigeria economy is not in good shape due to the fall in the price of crude
oil in the international market and the fall in the value of Naira (Nigerian currency).
There is need to promote local design and manufacturing of goods and services
(Onuoha, 2013). Importation of goods into the country is believed to have seriously
undermined the nation’s growth and development (Buhari, 2016). Nigeria is now
looking inward for its economy growth, restricting foreign exchange on some items
and encouraging local manufacturers to start utilizing local raw materials in their
production.
Local production of electrical safety analyzers in Nigeria will make the device
affordable and available in nooks and corners of the country. This will improve the
safety and preventive maintenance of biomedical devices and healthcare delivery in
Nigeria. Engineers in different countries have been making efforts on indigenous
development of electrical safety analyzer and other biomedical devices (Jiju et al.,
2011).
In this work, an electrical safety analyzer is designed and constructed. The
International Electrotechnical Commission (IEC) 60601-Medical Electrical Equipment
standard provides the guidelines or regulations which are adhered to in the design
and construction of the analyzer. The International Electrotechnical Commission is a
non-profit, non-governmental international standards organization that prepares and
publishes International Standards for all electrical, electronic and related technologies
– collectively known as "electrotechnology" (Fadhl, 2013). In Europe the IEC has
established standards 60601 and 62353 (Becks, 2007; Park, 2014). These standards
dictate which types of tests are to be performed and the acceptable limits for each of
the different measurements. Typical tests on medical devices include Earth/Ground
resistance, leakage current, device current and mains voltage (Fluke, 2008).
The Electrical safety analyzer has been designed to meet all of the requirements
for testing hospital equipment according to the stated international standard (Cadick
et al., 2006). The various readings obtained are compared with the device under test
(DUT) ratings to ensure that the actual value remains within prescribed save limits.
II. Methods
A. Key Components
Components used in this work include ATmega16 Microcontroller, TL072
JEFET-Input Operational Amplifier, LM358 Single Supply Dual Operational-Amplifier,
LM7805 Voltage Regulator, and 20 x 4 Liquid Crystal Display (LCD).
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Abdul R. Zubair, Olajide J. Odelanu, Obinna M. Ibe, Akinwale O. Coker, Academic and Applied Studies Vol.6 (Q.2), 2016, 1-19
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Abdul R. Zubair, Olajide J. Odelanu, Obinna M. Ibe, Akinwale O. Coker, Academic and Applied Studies Vol.6 (Q.2), 2016, 1-19
R4 10
Vout x Vin x Vin 0.0103 x Vin (1)
R1 R2 R3 R4 972
Equation (1) is ideal. To obtain a more practical relationship between Vin and
Vout, linearization experiment was carried out. Vin (y) was varied from 10V to 240V
and a corresponding value of Vout (x) was measured and recorded as presented in
Table 1. For a linear relationship,
y a bx (2)
where a and b are the intercept and slope respectively. Using the mathematical least-
squares line-fitting technique described in (3) (Weisstein, 2016).
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n
x a y
x x b xy
2
(3)
where n is the number of iterations.
From Table 1, (3) becomes
16 20.243 a 1970
20.243 34.845265 b 3390.49 (4)
Solution of (4) gives a = 0.0777 and b = 97.2562, y 0.0777 97.2562 x and therefore
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Abdul R. Zubair, Olajide J. Odelanu, Obinna M. Ibe, Akinwale O. Coker, Academic and Applied Studies Vol.6 (Q.2), 2016, 1-19
a and b are the intercept and slope respectively. Using the mathematical least-squares
line-fitting technique described in (7).
n
y a x (7)
y y b xy
2
Solution of (8) gives a = -7.8683 x 10-4 and b = 0.0103, x 7.8683 x 10 4 0.0103 y and
therefore
Vout 7.8683 x 10 4 0.0103Vin
(9)
Vout serves as input to the Analog to Digital Converter (ADC) which is inside the
microcontroller. The output of the ADC is Count which is binary. 0-5V range of Vout is
made to correspond with the 0000000000-1111111111 range of Count. Vout is pulse
code modulated by ADC with 10 bits, 1024 quantized levels and a step size of
4.887589mV ( 5 1023 V). ( 1023Vout 5 ) in base 10 is evaluated and approximated to the
nearest whole number and then converted to base 2 to give Count as in (10).
1023
Count Binary Vout approximated to nearest whole number (10)
5 10
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Abdul R. Zubair, Olajide J. Odelanu, Obinna M. Ibe, Akinwale O. Coker, Academic and Applied Studies Vol.6 (Q.2), 2016, 1-19
Np
VR 5 x R5 x I
Ns
(11)
For this design, Np = 3, Ns = 1500, R5 = 470Ω. Thus for maximum device current
of 5A, VR5 = 4.7V. A precision full wave rectifier is used to rectify VR5 instead of full
wave bridge rectifier due to the problem of forward voltage drop associated with
bridge rectifier [9]. As shown in Figure 3(b), the precision rectifier consists of dual
operational amplifiers (configured as unity gain inverting and summer amplifier). The
rectified voltage Vout is given by (12) (Bode, 2008). For this design, Vin = VR5, R6 = 10k,
R7 = 10k, R8 = 10k, R9 = 20k and R10 = 20k. Therefore, Vout = Vin and Vout is given by
(13).
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Abdul R. Zubair, Olajide J. Odelanu, Obinna M. Ibe, Akinwale O. Coker, Academic and Applied Studies Vol.6 (Q.2), 2016, 1-19
R 7 R9 R9
Vin x for Vin 0
R6 R8 R10
Vout
R9
Vin for Vin 0
R10
(12)
Np
Vout x R5 x I
Ns
(13)
Eqn. (13) is ideal. To obtain a more practical relationship between I and Vout,
linearization experiment was carried out. Load of various ratings are used. Device
current I (y) and precision rectifier output Vout (x) were measured and recorded as
presented in Table 2.
TABLE 2
DEVICE CURRENT MEASUREMENT LINEARIZATION EXPERIMENTAL RESULTS
S/N y I (A) x Vout (Volt) y2 x2 xy
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Vout serves as input to another Analog to Digital Converter (ADC) which is also
inside the same microcontroller. The output of the ADC is Count which is binary and
which is similar to that encountered in section 2.3 and (10).
An algorithm was developed for the microcontroller to convert Count to Idisplay
which is displayed by the liquid crystal display (LCD) unit. The algorithm relates I display
with I by first caring out pulse code demodulation (decoding (10)) to obtain Vout from
Count and substituting Vout in (15) to evaluate I which is displayed as Idisplay on LCD.
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high input impedance JFET operational amplifier is included to amplify the signal to
an appreciable level. The output voltage of the JFET op-amp in the non-inverting
configuration as given by (18) (Bode, 2008).
R 21
Vout 1 x VR13
R 20
(18)
NP 2
where VR13 x R13 x I L x R13 x I L
NS 250
(19)
For this design, Np = 2, Ns = 250, R13 = 10 KΩ, R20 = 2 KΩ and R21 = 240 KΩ. Thus for
maximum leakage current IL=0.5mA, VR13 = 40mV and Vout = 4.84V.
Vout serves as input to another Analog to Digital Converter (ADC) which is also
inside the same microcontroller. The output of the ADC is Count which is binary and
which is similar to that encountered in section 2.3 and (10).
An algorithm was developed for the microcontroller to convert Count to ILdisplay
which is displayed by the liquid crystal display (LCD) unit. The algorithm relates ILdisplay
with IL by first caring out pulse code demodulation (decoding (10)) to obtain Vout from
Count and substituting Vout in (18) and (19) to evaluate IL which is displayed as ILdisplay
on LCD.
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Abdul R. Zubair, Olajide J. Odelanu, Obinna M. Ibe, Akinwale O. Coker, Academic and Applied Studies Vol.6 (Q.2), 2016, 1-19
5 Rg 1 1
Vout , 0.2 200
Rg R 23 Vout Rg
(20)
1 1
Therefore, 0.001 0.005
Rg Vout
(21)
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Eqn. (20) is ideal. To obtain a more practical relationship between R g and Vout,
linearization experiment was carried out. Different known resistors are used in place
of Rg and Vout is measured and recorded in Table 3.
TABLE 3
GROUND RESISTANCE MEASUREMENT LINEARIZATION EXPERIMENTAL RESULTS
x 1 Vout y2 x2 xy
S/N y 1 Rg
1 1
0.1289 200.09
Vout Rg
(25)
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Abdul R. Zubair, Olajide J. Odelanu, Obinna M. Ibe, Akinwale O. Coker, Academic and Applied Studies Vol.6 (Q.2), 2016, 1-19
Vout serves as input to another Analog to Digital Converter (ADC) which is also
inside the same microcontroller. The output of the ADC is Count which is binary and
which is similar to that encountered in section 2.3 and (10).
An algorithm was developed for the microcontroller to convert Count to Rgdisplay
which is displayed by the liquid crystal display (LCD) unit. The algorithm relates
Rgdisplay with Rg by first caring out pulse code demodulation (decoding (10)) to obtain
Vout from Count and substituting Vout in (23) to evaluate Rg which is displayed as
Rgdisplay on LCD.
G. Additional Features
The Electrical Safety Analyzer can be used to carry out safety tests on a
biomedical device after routine maintenance to ascertain that the device is safe for
use. The Electrical Safety Analyzer is fitted with additional features to enable it to be
used for monitoring of parameters of a biomedical device while in operation.
Whenever any of the parameters is outside safe range, the Electrical Safety Analyzer
isolates the device under use from the supply and activates a buzzer to alert the user
of the device.
The microcontroller is programmed such that whenever Vdisplay is outside the
range 220V±10%, it generates a signal to switch off a relay to isolate the device under
use.
The user is expected to set a limit for the device current I limit based on
manufacturer’s specification with the aid of a labeled rotary potentiometer VR1
shown in Fig. 6. Whenever Idisplay is greater than Ilimit, the microcontroller generates a
signal to switch off a relay to isolate the device under use.
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Abdul R. Zubair, Olajide J. Odelanu, Obinna M. Ibe, Akinwale O. Coker, Academic and Applied Studies Vol.6 (Q.2), 2016, 1-19
TABLE 4
COMPARISON OF MEASUREMENTS BY IMPORTED AND LOCALLY CONSTRUCTED ELECTRICAL SAFETY
ANALYZER
Mains Voltage Device Current Leakage Ground
(V) (A) Current (mA) Resistance (Ω)
Device Import Local Import Local Import Loca Import Local
Name ed ESA ESA ed ESA ESA ed ESA l ed ESA ESA
ESA
Hp 218 218. 0.06 0.06 0.00 0.00 0.51 0.50
Defibrillator 3
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Parameters %
Accuracy
Voltage 0.16
Device Current 2.22
Leakage 0.00
Current
Ground 1.80
Resistance
IV. Conclusions
The measurements made by the electrical safety analyzer constructed in this
work compare favorably well with those measurements made by imported electrical
safety analyzer on same medical equipment. A portable low cost electrical safety
analyzer with acceptable level of accuracy has been designed and constructed. Local
manufacturing of this device in large quantities will improve the safety and
preventive maintenance of biomedical devices and healthcare delivery in Nigerian
hospitals.
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