DEVELOPMENT OF A CALIBRATION TOOL FOR

INCUBATORS FOR NEONATAL PATIENTS IN THE

CITY OF MANAUS (BRAZIL, 2022)
Ricardo Souza de Lima Junior, Samuel Agostinho Ferreira, Newton Lima,
Newton Silva de Lima

To cite this version:

Ricardo Souza de Lima Junior, Samuel Agostinho Ferreira, Newton Lima, Newton Silva de Lima.
DEVELOPMENT OF A CALIBRATION TOOL FOR INCUBATORS FOR NEONATAL PATIENTS
IN THE CITY OF MANAUS (BRAZIL, 2022). XIII Mostra Científica - ULBRA Manaus | XIX
Semana Nacional de Ciência Tecnologia & Inovação, 2022, Oct 2022, Manaus, Brazil. �hal-03908757�

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DEVELOPMENT OF A CALIBRATION TOOL FOR INCUBATORS FOR NEONATAL
PATIENTS IN THE CITY OF MANAUS
(BRAZIL, 2022)
Ricardo Souza de Lima Junior1
Samuel Agostinho Ferreira 2
Newton Silva de Lima3

Abstract
In neonatology, the vulnerability of prematurely born patients is high and for this
reason they require special care to ensure the evolution of the clinical picture. Thus,
the use of neonatal incubators is primordial for the maintenance of their lives,
considering that they create an ideal environment, thus enabling the self-regulation of
body heat. However, their use must respect principles that ensure their functionality,
for this the Brazilian Technical Standard NBR 15943-2011 determines the guidelines
to be adopted by health establishments regarding the management of their
technologies, because through these programs it is possible to ensure the reliability
of the use of this equipment. To this end, the performance of calibration tests is a
mandatory factor, since this procedure certifies the veracity of the parameters offered
by this equipment during its use. This procedure is done by performing a set of
standardized steps with the help of an analyzer built to perform specific functions,
certifying the usability of the equipment through the analysis and comparison of
acquired data. However, the calibration instruments available in the market are
expensive and sometimes their availability is low, which can compromise the
execution of this type of service in hospitals. Thus, in this work, we will approach the
development of a low cost calibration instrument capable of measuring temperature,
humidity and noise, using affordable materials and with accuracy values within the
acceptable parameters of variation for the calibration of such equipment standardized
by NBR IEC 60601-2-19.

Keywords: NBR 17025, temperature, humidity, noise.

1
Electrical Engineering Academic, CEULM | ULBRA, ricardolima@rede.ulbra.br;
2
Electrical Engineering Academic, CEULM | ULBRA, sam.ago.fer@rede.ulbra.br;
3
Professor PhD, CEULM | ULBRA, newtonulbra@gmail.com
 2

Introduction
In neonatology, the importance of caring for prematurely born patients is
essential, because in this period their vulnerability is high and the health of these
individuals can be compromised by biological and environmental risks. Moreover, this
type of patient has difficulty in body regulation and may lose heat through
evaporation, radiation, convection and conduction (MINISTRY OF HEALTH, 2011).
Thus, it is necessary to define strategies that minimize the impacts caused by this
condition.
The use of hospital medical equipment for the treatment of patients is
widespread in society in general. Its role is essential for the patient's evolution,
considering that sometimes it performs functions that cannot be performed by human
beings. Thus, the use of neonatal incubators is indispensable for the treatment of
neonate patients, as their main function is to provide the newborn with a
thermo-neutral environment by controlling the temperature and relative humidity of
the air, in order to ensure the minimal production of body heat by the patient
(IAIONE, 1999).
However, the use of this equipment must respect principles to ensure the
reliability of the supplied parameters. For this, hospitals must have a management of
the technologies present in their technological park to ensure the traceability, quality,
efficacy, effectiveness, safety and performance, as stated by the National Health
Surveillance Agency (2010).
Thus, given the need to obtain consistent results and check whether the
information provided by a hospital medical device is cohesive, the calibration tests
are of paramount importance to provide the proper functioning of such equipment.
Moreover, calibration ensures the quality and credibility of patient care.
According to the International Metrology Vocabulary (2012), the definition of
calibration is a set of steps that establishes, under specified conditions, a relationship
between the values and measurement uncertainties provided by standards, using
this information to establish a relationship in order to obtain measurement results
from an indication.
In Brazil, the NBR IEC 60601-2-19 standard deals with the general provisions
for the performance and operation of neonatal incubators and determines that this
equipment must undergo periodic maintenance, stressing the importance of
performing annually or whenever necessary calibration tests and electrical safety
 3

analysis. To perform these services, equipment called analyzers are used, whose
purpose is to perform specific activities according to the purpose of the equipment
submitted to the procedures.
Currently, the analyzers present in the market are imported and have a high
price, making it difficult to purchase them; moreover, their cost-benefit ratio is low,
since these analyzers have outdated technology and complex operation.
As a result of the covid-19 pandemic and the increase in the production of
electronic equipment, silicon (ore used in the production of semiconductor
components and indispensable for making electronic boards) became scarce.
Because of this, the creation of alternative devices using accessible technologies has
become widespread. With this, it was observed that neonatal incubators provide
physical quantities that can be measured by low-cost sensors on the market.
Based on this principle, followed by the question: "is it possible to create a
calibration instrument for neonatal incubators using affordable resources available on
the market?", this paper was developed based on the following objective: To develop
a low-cost calibration device for measuring physical quantities provided by an
incubator for neonatal patients, which is able to perform the sensing and statistical
treatment of the data collected from the equipment:
● Measuring physical quantities such as: temperature, humidity and
noise;
● To be low cost, easy to handle, and reliable;
● Being able to perform the statistical treatment of the collected
parameters;
● Issue detailed reports and reports of the parameters provided by the
equipment being measured.
Therefore, the development of a calibration instrument using accessible and
low cost resources is not new, especially for incubators, however, with the
technologies present in the market and the accessibility of these items, the evolution
of the devices has been facilitated, integrating new ways of performing already
consolidated tasks in a simplified, efficient and effective manner. Throughout this
article, the construction of the proposed device and its integration with new
technologies will be described.
This project was submitted to the Research Ethics Committee of
CEULM/ULBRA, through Platform Brazil (CONEP).
 4

Materials and Methods

The project was developed in three stages, arranged as follows: planning,
construction and assembly of the prototype, and functional tests and direct
comparisons of the results.
1. Planning
During the planning stage, the physical quantities provided by the equipment
to be tested were taken into consideration. Thus, it was observed that neonatal
incubators, in general, have as their main functions the control of temperature,
humidity and oxygen. However, due to the hot air circulation system generated by the
resistance, a characteristic noise inside the incubator that needs to be measured is
noticeable, since the Brazilian standard NBR IEC 60601-2-19:2014 "Electromedical
equipment - Particular requirements for basic safety and essential performance of
incubators for newborns" establishes that the maximum sound level inside incubators
in normal operation mode should be 60.0 dB. Therefore, the construction of the
calibration procedure was focused on the parameters found in this type of equipment,
with the exception of oxygen. Thus, the sensors to be used to build the prototype
were selected to measure temperature, humidity and noise.
The prototype construction was focused on the use of accessible and low-cost
tools, aiming to guarantee the same reliability in relation to the equipment already on
the market. That said, the operating principle of the instrument developed was
divided into stages, structured as follows: sensing, processing, treatment, and
reporting.

Figure 1: Process flowchart.

Source: Authors, 2022.

 5

Sensing
The sensing stage will be performed through the use of sensors that will
acquire the data provided by the measured equipment:
Temperature and humidity sensor DHT22:

Figure 2: DHT22 sensor.

Source: Datasheet DHT22, 2017.

 6

Noise Sensor KY037

Figure 3: Noise sensor KY-037.

Source: Datasheet Ky-037, 2020.

Processing
For the processing of this data acquired by the sensing stage we used a
programmable board called ESP 32, which has the possibility of integrating its
functionality via wifi and currently has high accuracy compared to competing
embedded. This data will be sent to the MATLAB platform through an MQTT server
located in a domain that also belongs to mathworks, via internet connection.
 7

Server Mqtt - ThingSpeak

Figure 4: Interface ThingSpeak.

Source: Authors, 2022.

 8

Figure 5: ESP-32 Module.

Model ESP-WROOM-32

Power Supply 2,7 a 3,6 VDC

Output Signal Analog and Digital (including PWM)

Processor Xtensa 32-Bit LX6 Dual Core

WiFi 802.11 b/g/n: 2.4 a 2.5 GHz

Resolution 32-Bit of access and 4Mb

Interfaces UART, SPI, SDIO, I2C, I2S, IR, PWM;

Support Arduino IDE, Lua e MicroPython, Code C basic;

Source: Datasheet ESP-Wroom-32, 2020.

Treatment
The treatment of the data provided by the ESP 32 will be processed by a
firmware developed in the Matlab platform, which will be responsible for the
integration of the user interface and statistical treatment of the collected data. In this
way, the operator will be able to visualize the execution of the procedure.
Report
At the end of the calibration procedure, a report will be developed to show the
events observed during the calibration test, thus classifying the equipment's
suitability for use. In addition, it will contain information related to the identification of
the equipment, customer, and service provider, thus constituting a standardized
report that can be traced later.
 9

Figure 6: Interface App Designer.

Source: Authors, 2022.

2. Building and assembling the prototype

The prototype assembly was divided into two parts where the firmware was
developed to perform the programming, control, and distribution of the data, and the
hardware, responsible for the acquisition and processing of the obtained data.
The hardware consists of a logic board responsible for processing the data
obtained through sensors that will be strategically positioned inside the incubator.
The processing of this data is performed by programming based on some internal
conversion calculations of the board used. The ESP-32 was chosen because of its
resolution in receiving data that is more accurate than other competitors, thus
avoiding a percentage of error when collecting these data from the physical
environment.
Therefore, the data collected during the measurement will be forwarded to a
MQTT server, which will only have the function of allocating and making available the
data provided by the ESP. The data will be statistically treated by Matlab software.
To build the application responsible for the interface and data processing, the
app designer was used, MATLAB's graphical customization tool, which allowed the
construction of a customized interface according to the needs of the calibration
procedures. The graphical interface was built in a simplified way aiming at an easy
understanding for those who operate it, thus allowing the initialization of the
 10

calibration procedure steps, which can be executed according to the predefined

programming in the equipment under test. With this, the information collected by the
hardware will be processed by a statistical calculation, where the standard deviation,
measurement uncertainty and k factor will be verified, in order to make sure that the
equipment's operation is within what is expected for its error margin, thus ensuring its
suitability for use.
The calibration test will be divided according to the programming of the
temperature in the incubator designed to be collected every 5 min at a frequency of
three times for each sample. The temperatures used in the programming are: 30°C,
35°C, and 39°C.

3. Functional tests and direct comparisons of results

During this step, it was necessary to perform a series of tests to ensure the full
operation of the flowchart already established (sensing, processing, treatment and
reporting), where the verification of the operation of the sensors was performed as
well as the veracity of the measured values, the ESP connection with the wifi network
and sending packets to the MQTT server, after this verification and from there the
data could already be monitored. The next test was the connection to the MATLAB
platform and the integration of the obtained values with the statistical treatment code
to be visualized via the user interface application. Therefore, after ensuring the full
operation of the system, the calibration tests could be performed.
Initially in the prototyping phase, it was necessary to build an environment
where it would be possible to simulate an incubator, so an adiabatic environment was
built with cardboard box material for the casing, Styrofoam for thermal insulation, and
reflective tape to ensure that the internal environment was as isolated as possible
from the external environment, where we could have a fixed temperature value to be
verified the variation of the sensor. However, during the execution of the tests,
inconsistencies were observed in the values offered for measurement, indicating
variation in the values obtained.
Thus, there was the need to perform the tests with consistent values so that
the validation of the developed analyzer's operation could be concluded. For this, the
Fanem IT-158/TS neonatal transport incubator provided by the clinical engineering of
the Balbina Mestrinho State Maternity was used. This equipment in question is out of
 11

circulation due to compromised structures, thus not being used by the medical staff of
this hospital unit.
During the calibration test, a device to check temperature and humidity called
Thermohygrometer was used to help compare the values obtained by the analyzer,
thus making it possible to check the linearity and accuracy of the data obtained.
Then, the calibration test was performed for 24 hours in order to check the full
operation of the equipment under test. During the verification it was possible to notice
a variation in the values shown in the incubator in relation to the values measured by
the analyzer and the thermohygrometer, thus indicating the need for intervention in
the equipment measured, through corrective maintenance.
The data obtained by the analyzer and the hygrometer were similar throughout
the procedure, presenting minimal variations between 0.10°C and 0.20°C.

Simulation in Incubator A (temperature parameters)

Graph 1. 24h data - Temperature.

After the simulation of the calibration test was completed, a Wavelet (Wavelet
Graph) was performed with the data obtained, so that it is possible to highlight the
consistency of the measurements during the procedure.
 12

Graph 2. Temperature - Wavelet Transform

Final Considerations
During this article, the development of a calibration instrument for neonatal
incubators was presented, which had as objectives the creation of a low cost and
simplified usability analyzer that would ensure the same quality and safety as the
equipment already on the market. As shown in the results, the developed instrument
has the ability to accurately measure measurable physical quantities such as
humidity, temperature and noise, and is able to perform statistical treatments with the
data collected by it, ensuring the reliability of the parameters delivered by the
equipment under test. In addition, the MATLAB platform enabled the integration of
new resources, which allowed communication via the internet, not requiring the
connection of cables for data transmission, being sent via MQTT server.
The development of calibration instruments for neonatal incubators is not a
new subject and it is possible to find several projects with the same objective,
however, with technological advances it is possible to integrate new technologies
present in the market, thus bringing innovation to this type of procedure. The results
obtained during the testing phase open possibilities for changes in the way that the
collection of this data is carried out for the expected purpose, in order to speed up
the existing process, with currently available technology. Therefore, the performance
obtained during the testing phase proved satisfactory, considering that the proposed
objectives were met.
 13

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