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Safety and Preventive Maintenance of Biomedical Devices in Nigerian


Hospitals: A Portable Low Cost Electrical Safety Analyzer

Article · January 2016

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Abdul Rasak Adegoke Zubair Olajide J Odelanu


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Academic and Applied Studies Vol.6 (Q.2), 2016, 1-19, ISSN: 1925-931X
Special issue on Electronic & Electrical Sciences

Journal of Academic and Applied Studies

Content available online @ www.Academians.org

Safety and Preventive Maintenance of Biomedical


Devices in Nigerian Hospitals: A Portable Low Cost
Electrical Safety Analyzer

Abdul R. Zubair*1, Olajide J. Odelanu2, Obinna M. Ibe3, Akinwale O. Coker4


1
Electrical/Electronic Engineering Department, Faculty of Technology, University of
Ibadan, Ibadan, Nigeria.
2
Electronic/Electrical Engineering Department, Ladoke Akintola University of
Technology, Ogbomosho, Nigeria
3
Stimulation and Sand Control at Schlumberger Nigeria Limited, Port Harcourt, Nigeria
4
Civil Engineering Department, Faculty of Technology, University of Ibadan, Ibadan,
Nigeria

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).

Keywords: Biomedical Devices, Safety, Measurement, Signal Processing, Nigerian


hospitals.
I. Introduction
Medical instruments are devices intended to diagnose, treat, or monitor the patient
under medical supervision. Regular care, repair and preventive maintenance of these

*Corresponding email address: ar.zubair@ui.edu.ng


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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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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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The ATmega16 is a low-power Complementary Metal Oxide Semiconductor


CMOS 8-bit microcontroller based on the Advanced Virtual RISC (Reduced Instruction
Set Computing) AVR enhanced architecture. This microcontroller has eight distinct 10
Bit Analog to Digital Converts (ADC) four of which are used for the various subsystems.
The TL072 is a Junction Field Effect Transistor (JFET) input operational amplifier with
high input impedance, low power consumption, wide common-mode and differential
voltage range, low input bias and offset currents.
The LM358 consist of two independent, high gain (100dB), internally frequency
compensated operational amplifiers which were designed specifically to operate from
a single power supply over a wide range of voltage 3-32V.
The LM7805 is a three terminal positive regulator available in the TO-220/D-
PAK package. It employs internal current limiting, thermal shut down and safe
operating area protection, making it essentially indestructible. The LCD used is an
industry standard HD44780 based controlled 4 lines x 20 characters LCD display with
BLACK characters on GREEN background and backlight. It has a wide viewing angle
and high contrast. Other supportive components used include resistors, capacitors
and diodes (Rowe, 2012; Theraja and Theraja, 2005). The ESA contains appropriate
electrical circuits to convert current or resistance measurement signals into suitable
voltage signals.
B. Power Supply Unit
The power supply unit is designed to provide regulated +5V DC and +12V DC
for other units. The ATmega16 Microcontroller, the TL072 JEFET-Input Operational
Amplifier, the LM358 Single Supply Dual Operational-Amplifier, the LM7805 Voltage
Regulator, and 20 x 4 Liquid Crystal Display (LCD) require +5V DC. 5V DC is also the
reference voltage for the Analog to Digital Converters (ADC) embedded in the
microcontroller. Relays require +12V DC. The block diagram and circuit diagram of the
power supply unit are presented in Fig. 1.

C. Voltage Measuring Sub-System


The block diagram and circuit diagram of the voltage measuring sub-system
are shown in Fig. 2. The mains supply voltage Vin is rectified by a bridge rectifier BR2.
Resistors R1, R2, R3 and R4 constitute the voltage divider network. Capacitor C2
removes ripples in the rectified voltage. Zener diode D1 limits Vout to 5V maximum.
0-500V range of Vin is made to correspond with 0-5V range of Vout. Vout is related to
Vin as in (1).

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Figure. 1. Power Supply Unit.

R4 10
Vout  x Vin  x Vin  0.0103 x Vin (1)
R1  R2  R3  R4 972

Figure. 2. Voltage Measuring Sub-System Supply Unit.

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

Vin  0.0777  97.2562Vout


(5)
TABLE I
VOLTAGE MEASUREMENT LINEARIZATION EXPERIMENTAL RESULTS

S/N y  Vin (Volt) x  Vout (Volt) x2 y2 xy

1 10 0.103 0.010609 100 1.03


2 20 0.206 0.042436 400 4.12
3 30 0.308 0.094864 900 9.24
4 50 0.513 0.263169 2500 25.65
5 70 0.719 0.516961 4900 50.33
6 90 0.925 0.855625 8100 83.25
7 100 1.027 1.054729 10000 102.70
8 110 1.130 1.276900 12100 124.30
9 120 1.235 1.525225 14400 148.20
10 140 1.430 2.044900 19600 200.20
11 160 1.645 2.706025 25600 263.20
12 180 1.852 3.429904 32400 333.36

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13 200 2.055 4.223025 40000 411.00


14 220 2.262 5.116644 48400 497.64
15 230 2.365 5.593225 52900 543.95
16 240 2.468 6.091024 57600 592.32
n  16  y  1970  x  20.243  x 2
 34.845265 y 2
 329900  xy  3390.49

For a linear relationship,


x  a  by (6)

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

where n = number of iteration


From Table 1, (7) becomes
 16 1970  a   20.243 
1970  (8)
 329900 b  3390.49

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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An algorithm was developed for the microcontroller to convert Count to Vdisplay


which is displayed by the liquid crystal display (LCD) unit. The algorithm relates
Vdisplay with Vin by first caring out pulse code demodulation (decoding (10)) to obtain
Vout from Count and substituting Vout in (5) to evaluate Vin which is displayed as Vdisplay
on LCD.

D. Device Current Measuring Sub-System


The block diagram of the device current measuring sub-system is shown in Fig.
3(a) while its circuit diagram is shown in Fig. 3(b). Current transformer T2 steps down
the device current I to a lower value which can be handled by the microcontroller. The
stepped down current flows through a shunt resistor R5. Voltage drop across R5 is
proportional to I which is the current flowing in the primary side of the current
transformer as shown in (11).

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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Figure. 3. Voltage Device Current Measuring Sub-System.

 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

1 0.7 0.595 0.49 0.354025 0.4165


2 1.7 1.446 2.89 2.090916 2.4582
3 2.5 2.125 6.25 4.515625 5.3125

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4 3 2.550 9.00 6.502500 7.6500


5 4.5 3.826 20.25 14.638276 17.2170
n5  y  12.4  x  10.542  y 2
 38.88 x 2
 28.101342  xy  33.0542

From Table 2, (3) becomes


 5 10.542  a   12.4 
10.542 28.101342  b   33.0542
    
(14)
Solution of (14) gives a = -0.000025 and b = 1.1763, y  0.000025  1.1763 x and
therefore
I  0.000025  1.1763Vout
(15)
From Table 2, (7) becomes
 5 12.4  a  10.542 
12.4 38.88 b   33.0542 (16)
    
Solution of (16) gives a = 2.1654 x 10-5 and b = 0.8502, x  2.1654 x 10 5  0.8502 y and
therefore
Vout  2.1654 x 10 5  0.8502 I (17)

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.

E. Leakage Current Measurement Sub-System


The leakage current measurement is very similar to the device current
measurement as shown in Fig 4. The current sensor is connected between the chassis
of the device under test and the earth. The leakage current IL is smaller compared with
device current I. Hence, a more sensitive current sensor is required; turns ratio of T3
and value of R13 are different from those of their equivalents in Fig 3. Furthermore, a

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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.

F. Ground Resistance Measuring Sub-System


The block diagram of the ground resistance measuring sub-system is shown in
Fig. 5(a) while its circuit diagram is shown in Fig. 5(b). The ground resistance refers to
the resistance between the chassis of the device under test and earth. A known
resistance R23 = 1 KΩ is connected in series with the ground resistance Rg of the device
under test. Rg is converted to Vout as given by (20).

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Figure. 4. Leakage Current Measuring Sub-System.

5 Rg 1 1
Vout  ,  0.2  200
Rg  R 23 Vout Rg
(20)
1 1
Therefore,  0.001  0.005
Rg Vout
(21)

Figure. 5. Ground Resistance Measuring Sub-System.

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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 1.0000 200.20020 1.00000 40080.12016 200.20020


2 0.6667 133.52918 0.44444 17830.04088 89.01945
3 0.5000 100.20040 0.25000 10040.12032 50.10020
2.1667 433.92978 1.69444 67950.28136 339.31985
n3  y  2.16674  x  433.92978 y 2
 1.69444 x 2
 67950.28136  xy  339.31985

From Table 3, (3) becomes


 3 433.92978  a   2.16674 
433.92978 67950.28136  b   339.31985
    
(22)
Solution of (22) gives a = -6.6825 x 10-4 and b = 0.005, y  6.6825 x 10 4  0.005 x and
therefore
1 1
 6.6825 x 10 4  0.005
Rg Vout
(23)
From Table 3, (7) becomes
 3 2.16674  a  433.92978
2.16674 1.69444 b   339.31985 (24)
    
Solution of (24) gives a = 0.1289 and b = 200.09, x  0.1289  200.09 y and therefore

1 1
 0.1289  200.09
Vout Rg
(25)

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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 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.

Figure. 6. Circuit for Pre-setting Device Current Limit.

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The International Electrotechnical Commission standard requires maximum


leakage current of 0.5mA for a single fault condition for a Class I device. The United
States of America standard requires a maximum leakage current of 0.3mA. This is to
ensure maximum protection against electric shock. This work adopted the United
States standard in this aspect. Whenever ILdisplay is greater than 0.3mA, the
microcontroller generates a signal to switch off a relay to isolate the device under use.
The complete circuit of the Electrical Safety Analyzer is presented in Fig. 7.
III. Results and Analysis
An imported electrical safety analyzer known as the BC Biomedical SA-2005 and the
locally constructed electrical safety analyzer were used to carry out the same
measurements on various medical devices at the University Teaching Hospital (UCH),
Ibadan, Oyo State, Nigeria. The results are presented in Table 4. Table 5 shows the
average percentage accuracy of the locally designed electrical safety analyzer
compared with the imported electrical safety analyzer.
The constructed Electrical Safety Analyzer presents acceptable accuracy. It is
observed that the accuracy of the locally constructed ESA compared to the existing
imported ESA is approximately 2.22%. The Food and Drug Administration (FDA)
stipulates that a device’s measurements must fall within a range of ± 20%. The tests
performed show that the constructed Electrical Safety Analyzer is well within the FDA
requirements.

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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

Figure. 7. The Complete Circuit Diagram of Electrical Safety Analyzer.

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

Marathon 217 217. 0.22 0.23 - - N.G. N.G.


Patient 5
Monitor
Local 217 217. 0.56 0.57 0.01 0.01 0.61 0.62
Ultrasound 4

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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

Pump 218 217. 0.03 0.03 - - N.G. N.G.


Syringe 9
Huntleigh 216 216. 0.21 0.20 - - N.G. N.G.
Patient 4
Monitor
Key N.G. – Device has no ground wire
TABLE 5
AVERAGE PERCENTAGE ACCURACY OF LOCALLY DESIGNED ELECTRICAL SAFETY ANALYZER COMPARED
WITH IMPORTED ELECTRICAL SAFETY ANALYZER

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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