Desing and Test of An Incubator Analyzer: Ntroduction

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Desing and Test of an Incubator Analyzer

Gamze Tilbe Şen Mehmet Yüksekkaya


Department of Biomedical Engineering Department of Biomedical Engineering
Başkent University Başkent University
Ankara, Turkey Ankara, Turkey
[email protected] [email protected]

Abstract— Incubators are cabins that provide the For newborn babies, body temperature is accepted as one
environment with necessary conditions for premature or of the most important variables of life. Body temperature
newborn babies, and they are designed to allow monitoring and measurement is usually performed in the detection of fever in
care of the baby. The incubator analyzer is the analyzer that the pediatric age group hence for infants it is performed to
shows the performance of the incubator. Knowing how close the observe if they can maintain their body temperatures. It is
values of a medical device are to the actual values is very known that body temperature has a daily rhythm and this
important in the treatment process. To ensure the accuracy of rhythm can be affected by many factors such as the presence
medical devices, tests and controls are required. As a result of of disease, ambient temperature or clothing. According to the
periodic tests and controls, it is possible to reduce the risks by
American Academy of Pediatrics (AAP) baby body
preventing incorrect measurements. If the temperature,
humidity and oxygen sensors of the incubators are measured
temperature is considered to be normal between 36.1 - 38 °C.
incorrectly, the baby's life would be threatened. This study aims Premature newborn babies have high skin permeability,
to determine the design requirements of a single incubator because of this it is vital for keeping the temperatures to the
analyzer that measures heat, oxygen and humidity in the certain levels. The incubator indicator becomes more
incubator and to design an analyzer. The general design of the important for newborns. As well as, heat loss should be
incubator analyzer consists of a battery circuit, a prevented by convection by keeping relative humidity
microcontroller, a liquid crystal display (LCD) screen, five between 60% - 65% in incubators. In order to have proper
temperature sensors, a humidity sensor and an oxygen sensor. respiratory activity accurate relative humidity is also
Incubator standards of our country and EU has been reviewed important [2].
according to the design. In addition, within the scope of the
project, the sensors in accordance with the standards have been In United States, as a result of retinopathy of prematurity
researched and determined, but due to their high cost, (ROP) blindness are estimated to occur in about 7.000 babies,
alternative sensors are preferred. By that the design of the between the years 1943-1953. In those years’ factors such as
analyzer can be a model for the actual device. Proper firmware light exposure, infection, anoxia, anemia, iron deficiency,
is programmed for temperature, oxygen and humidity sensors, hormone deficiency, have been implicated as the cause of this
and data from those sensors are processed and displayed on a epidemic blindness affecting premature babies. Besides, many
LCD screen. Also a suitable case is designed by computer aided studies in 1951-1956 reveal that the disease is caused by
programs. The analyzer is tested in incubators and functioned uncontrolled oxygen applied to newborns. Thereafter, the
properly. With this project, it is determined that a cost effective oxygen supply to premature babies was restricted and the
incubator analyzer can be designed and with more sensitive incidence of blindness decreased significantly [3].
sensors proper standards can be achieved. This project can be a
model for incubator analyzer design. Given these circumstances, control of the correct
functioning of the incubator used in the treatment of infants
Keywords—Incubator, Temperature Measurement, Humidity with an analyzer will help to prevent adverse situations.
Measurement, Oxygen Measurement, Calibration, Test Ultimately the purpose of this project is to perform a single
Equipment. analyzer design to measure and display the heat, humidity and
oxygen provided by the incubator. The temperature
I. INTRODUCTION differences in the different regions of the incubator will also
Incubators are devices, which are used to help the babies, be analyzed using multiple temperature sensors.
who’s born prematurely or problematic, to be able to continue
their vital functions. These devices are usually transparent, II. GENERAL INFORMATION
clean (sterile), they are with appropriate electronic equipment A. Incubator
and have sound isolation to allow monitoring and maintenance
Incubator is the cabinet where specific temperature,
of the baby. They provide the temperature and humidity
oxygen and humidity are specially created in which premature
environment, anti-bacterial filtered clean and necessary air
or newborn babies are placed in order to protect them from
which babies are accustomed to in the mother’s womb [1].
external factors that may cause harm [4].
The most important parameters used in the incubator to
Incubators are divided into fixed and transport type and
restore the health of the baby are temperature, humidity and
diversified as protection, care, monitoring and treatment. In
oxygen. These parameters are set by the medical personnel
addition to these, there are also infant beds which are called
according to the medical necessity and the babies are followed
heat beds to keep or increase the body temperature of
according to these adjusted values. Incorrect values directly
newborns; phototherapy process can be done in these beds and
affect the baby's vital functions. For instance as a result of a
also in incubators [5].
research of Ergün and friends, malfunctioned incubator used
for transferring the infants increased the rates of asphyxiation
(hypoxia) [1].

978-1-5386-4184-2/18/$31.00 ©2018 IEEE


B. Incubator Calibration
Incubator calibration is the process of reporting the results
of measurements to reveal the performance of the incubators,
using an analyzer device.
C. Incubator Standarts
The required standards for designing an incubator analyzer
are reviewed and shown below.
 IEC 60601-2-19:2009: Particular requirements Fig. 1. Temperature sensor test locations in an incubator.
for the basic safety and essential performance of
infant incubators. This standard is an When measuring the stability of the incubator temperature,
international standard and has been a source for the aim is to see the stability at the five determined points. In
the Turkish Standard. other words, it is determined the oscillation of temperatures at
these points. The maximum oscillation at each specified point
 TS EN 60601-2-19:2009: Specific features for should be 0.5 ºC.
the basic safety and essential performance of
infant incubators. The homogeneity test determines the distribution of the
temperature in the incubator. For this, the temperature
 TS EN 60601-2-20:2009: Specific features for difference between the center point and the other four points
the basic safety and performance of infant are examined. The temperature difference between M and A,
transport incubators. The performance tests of B, C, D must not exceed 1 ºC.
this standard are exactly the same as those of TS
EN 60601-2-19. Since it is only portable, it Incubators have an optional skin temperature sensor to
contains different technical standards related to monitor the body temperature of infants. This test is intended
its structure. to determine the accuracy of this sensor. The skin sensor is
placed close to the center and compared to the value at point
D. Incubator Performance Tests and Their Applications M in the final measurements. The difference with the center
Performance tests according to TS EN 60601-2-19 sensor must not exceed ± 0.3 ºC.
standard are given below.
The accuracy test between skin temperature and control
 201.12.1.101: Stability of the incubator temperature is a completely visual test. The difference
temperature between the skin temperature indicator and the incubator
temperature indicator is checked. The difference should not
 201.12.1.102: Homogeneity of the incubator exceed 0.7 ºC.
temperature
The measurements of the sensors M, A, B, C, and D are
 201.12.1.103: Accuracy of Skin Temperature averaged to determine the temperature display of the
Sensor incubator. The difference between this average and the
 201.12.1.104: Accuracy between Skin indicator should be at most 0.8 ºC.
Temperature and Control Temperature The humidity sensor of the incubator analyzer is placed at
point M. A deviation of ± 10% RH is allowed between the
 201.12.1.105: Accuracy of Incubator Indicators
humidity value in the incubator display and the reference
 201.12.1.107: Warm-up Time (Optional humidity sensor.
Measurement)
III. MATERIAL AND METHOD
 201.12.1.108: Exceeded Set Temperature
(Optional Measurement) A. Determining the Temperature, Humidity and Oxygen
Sensors
 201.12.1.109: Humidity Indicator Accuracy There are three main parameters that will affect the vital
 201.12.1.110: Oxygen Control (Optional functions of the baby in the incubator:
Measurement)  Temperature, 20ºC - 39ºC ± 0,1ºC
 201.12.1.111: Air Flow Rate (Optional  Humidity, 30% RH - 95% RH ± 5% RH
Measurement)
 Oxygen Concentration, 65 ± 1% O2.
 201.12.1.112: Weighing (Optional
Measurement) Sensors that will communicate with a microcontroller to
measure these parameters and that will provide the
 201.9.6.2.1.101: Noise Tests (Optional measurement values specified in the standards are searched
Measurement) and proper ones are selected.
When performing performance tests, the incubator base is The temperature and humidity sensors use the capacitive
divided into four equal parts. Four temperature sensors are humidity sensor and thermistor to measure the ambient air.
placed in the center of these parts and one placed in the center The measurement of the relative humidity is a value that varies
of the base as shown (Fig.1). Ensure that the sensors are depending on the ambient temperature and the amount of
positioned five cm above the base. ambient oxygen. The DHT-22 temperature - humidity sensor
was used to measure the relative humidity in the incubator.
Humidity measurement to be performed within the scope
of the project will be carried out between 30% and 95%, ± 5%
RH. The humidity sensor to be used produces 0 - 3.7V output
amplitude value corresponding to 0-100% humidity. The
output voltage value of the corresponding sensor coincided
with the microcontroller analog input values, and did not
require external circuit designs (Fig.2).

Fig. 5. Arduino Uno - LCD display connection.

Serial Peripheral Interface (SPI) communication is used in


Fig. 2. Microcontroller – temperature and humudity sensor connections. LCD - Ardunio communication. (Fig.5).
Oxygen directly affects the relative humidity in the air. D. Battery Circuit
The internal air exchange with the ventilation system in the The LM7805 positive voltage regulator will be used in the
incubators causes the amount of oxygen in the environment to battery circuit. With On / Off switch, current will be given to
change. Therefore, in systems where the amount of oxygen is the circuit at any time. (Fig.6).
not monitored, can cause errors in the measurement of
temperature and relative humidity. Also proper oxygen level
is vital for infant. The OOM 102 oxygen sensor was used to
measure the amount of oxygen in the incubator (Fig.3).

Fig. 6. Battery circuit design.

E. Exterior Design
For exterior design plastic components which are easy to
process and easy to cut, have impact resistant and lightweight
Fig. 3. Microcontroller - oxygen sensor connection. are used. According to TS EN 60601-2-19 standard,
temperature sensors should be five cm above the incubator
B. Microcontroller base (Fig.7, Fig.8). Apart from the central sensor, a base stand
A microcontroller is the component that combines all the is designed to hold four other sensors.
units that must be contained in a computer system into a single
integrated circuit. As a microcontroller, Arduino Uno has been
preferred because of the possibility to produce electronic
solutions with a single microcontroller and to store the
program in it and to work when required (Fig.4).

Fig. 7. Overall case design.


Fig. 4. Arduino uno as an electronic controller.

C. Display (LCD)
The Nokia 5110 is a low-cost LCD display, with a size of
84 × 48 pixels, supplied with 3.3V and easy to use.
Fig. 10. Testing the device in the humidity cabinet.

TABLE I. HUMIDITY TEST RESULTS


Reference Device Incubator Analyzer Deviation Value
Fig. 8. The symbolic drawing of the overall exterior design. (% Rh) (% Rh) (% Rh)
35.40 39.10 3.70
F. Design 41.55 43.80 2.25
50.40 52.80 2.40
The block diagram of incubator analyzer is shown below
(Fig.9).
In order to check the correct measurement of the
temperature sensor, temperature changes were made at 120
minutes intervals in the air conditioning cabinet (Fig.11). The
results obtained were within the ranges specified in the
standards (Table 2).

Fig. 11. Testing the device in the Air Conditioning.


Fig. 9. Incubator analyzer block diagram.
TABLE II. TEMPERATURE TEST RESULTS
IV. EXPERIMENTS & RESULTS REFERENCE INCUBATOR DEVIATION
DEVICE ANALYSER VALUE
A. Experiments and Results of Humidity and Temperature (ºC ) ( ºC ) ( ºC )
Tests 23.55 24.10 0.55
The sensor response was monitored by changes in ambient 30.50 30.90 0.40
humidity and temperature. During measurements, the sensor
has taken a measurement per second. In order to ensure that 35.20 34.90 -0.30
the values shown on the display do not change too much, the
average values of each of the ten readings of the sensor are
taken and printed on the LCD. The sensor accuracy was also B. Experiments and Results of Oxygen Tests
checked using the humidity cabinet and the air conditioning Usually chemical substances are used for the measurement
cabinet (Fig.10). Moisture is increased by increasing the of oxygen level. The ME2-O2 Oxygen sensor are used in the
humidity inside the cabinet. Humidity was reduced by using a design. It has a longer service life and a wider measuring range
vacuum motor at 30-minute intervals. A total of 3 values were than other sensors.
compared and the levels of acceptability were compared to
standards, as a result the values were found to be appropriate Arduino UNO has a 10-bit analogue to digital converter
(Table 1). (ADC). If zero volts are given to Arduino, the output value
will be zero, and this value corresponds to 0% oxygen
concentration. If five volts are given to Arduino, the output
value will be 1024, and this value corresponds to 30% oxygen
concentration.
Lcd-Oxygen sensor connections were performed and the V. CONCLUSION
oxygen concentration was read through the display (Fig. 12). With this project, it is determined that an incubator
calibrator can be designed. By using more sensitive sensors it
can also satisfies the requirements of the standards.
As a literature search, the incubator has been used in the
field of medicine, the incubator calibration procedure, the
investigation of the calibration standards, temperature,
humidity and oxygen sensor research were conducted.
Detailed investigation of the sensors was made and the
technical characteristics of the sensors were examined.
Standards for incubator calibration were reviewed. In order to
comply with the standards, the number of sensors of the
incubator analyzer was determined to be 5 points. Within the
scope of design, Microprocessor-LCD communication and
microprocessor temperature-humidity sensor communication
Fig. 12. LCD-Oxygen Sensor communication. and Microprocessor - Oxygen sensor communication are
provided by necessary firmware. The overall circuit of the
C. Incubator & Cost Analyses project has been designed, in addition the battery circuit and
The incubator analyzer was tested in an incubator and the the outer box design has been completed. Accuracy of the pre-
results were evaluated (Fig.13). boxing sensor was checked in the humidity and air
conditioning cabinet, and the acceptability of the obtained
values was evaluated. Printed circuit design was realized by
computer aided design, and the sensor, microcontroller, LCD,
rechargeable battery circuit, power switch, and charge input
connections are combined on the printed circuit.
The obtained test result are shown that with more accurate
sensors this analyzer can be used as an incubator analyzer.
ACKNOWLEDGMENT
Fig. 13. Testing the analyser in the incubator and comparing the results. The authors thank to Eren Kaya and Mehmet Oktay Eren
for their help in instrumentation, machining, PCB design and
Design and project work has been planned by taking into applying tests.
account realistic constraints/conditions (environmental
problems, sustainability, production, ethical, health, social and REFERENCES
political problems), and the costs of the materials used are
calculated (Table 3). [1] U. Ergün and U. Fidan, “Yeni doğan Ünitelerinde Kullanılan
Kuvözlerin Uzaktan İzlenilmesi,” Afyon Kocatepe Univ. J. Sci. Eng.,
vol. 16, 2016.
TABLE III. COST ANALYSIS REPORT.
[2] Anonymous, “Biyomedikal cihaz teknolojileri kuvözler,” Milli Eğitim
Cost Analysis Bakanlığı MEGEP Yayınları, Ankara, 2‐12, 2012.
₺ (Turkish [3] “Kalibrasyon.” [Online]. Available:
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[4] E. Kösa and N. Çınar, “Prevent hypothermıa in premature infants: use
1 Nokia 5110 Lcd 25 plastic wrap,” Balıkesır Heal. Sci. J., vol. 3, no. 3, pp. 161–165, 2014.
2 Arduino Uno 30 [5] E. Özdemirci, “Yenidoğan Kuvözleri İçin Performans Test Ünitesi,”
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3 ME2-O2 Oxygen Sensor 320
[6] “Koç Üniversitesi İnsan Araştırmaları Etik Kurulu - SSS | Araştırma ve
DHT-22 Temperature and Geliştirmeden Sorumlu Rektör Yardımcısı (AGSRY).” [Online].
4 40 *5 Available: https://vprd.ku.edu.tr/tr/irb/chr/sss. [Accessed: 31-May-
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5 Exterior Design 125
6 Power Bank 100
Total Cost 800

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