EP4237800A1

EP4237800A1 - Baby incubator measurement and calibrator device

Info

Publication number: EP4237800A1
Application number: EP21810724.1A
Authority: EP
Inventors: Baki KARABÖCE; Emel ARI; Hüseyin Okan DURMU
Original assignee: Tuebitak
Current assignee: Tuebitak
Priority date: 2020-10-28
Filing date: 2021-10-27
Publication date: 2023-09-06
Also published as: WO2022090949A1; TR202017210A2

Abstract

The invention, which is the subject of the present patent application, is a baby incubator measurement and calibrator device designed to measure the ambient conditions of baby incubators on the basis of the IEC 60601-2-19:2009 standard and to perform their calibrations practically, quickly and accurately on-site (inside the incubator) in a portable way, together with six types of main operating sensors on it. The device has a compact structure consisting of two main components that can be easily assembled with openable and foldable arms, and has temperature, humidity, oxygen concentration, sound pressure level, light and pressure sensors. Another feature of the device is that it contains a TFT display that can be mounted with the body, an electronic processor and a power unit with various electronic elements. The developed device performs tests in accordance with the IEC 60601-2-19:2009 standard, and it can also measure parameters of other ambient conditions such as light intensity and ambient pressure, which have a direct effect on newborn health. The device can be used in instant measurement mode, it can keep the data of the calibration made with the calibration mode in its memory, and it is possible to access these data with the developed interface. The sensors on the device are metrologically traceable. For this reason, the calibration process is performed by comparing the measurement data on the TFT screen of the device and the sensor values (temperature, humidity, etc.) on the baby incubator device.

Description

BABY INCUBATOR MEASUREMENT AND CALIBRATOR DEVICE

Technical Field

The invention is related to a baby incubator measurement and calibrator device that enables the measurement of parameters such as temperature, sound pressure level, oxygen concentration, light intensity, atmospheric pressure and moisture content of newborn incubators and calibration of baby incubators. The invention is placed within the measurement area related to measuring devices in the field of physics science (physical parameters such as temperature, humidity, sound pressure level, pressure, light intensity etc. measurement and digital information processing of these physical parameters). The invention includes verified reference measurement sources (sensors) for physical parameters required for calibration of newborn incubators. The calibration of newborn incubators can be done practically, quickly and accurately on site (inside the incubator) with the help of the invention.

Prior Art

Newborns born prematurely and/or with health problems are placed in an incubator until their vital signs, nutrition and adaptation to the external environment return to normal when they make transition to a different environment from the environment they are used to in the uterus. They may have difficulty in keeping their vital values such as body temperature at a sufficient level and stable manner, beacuse of not completing their development due to preterm birth, and/or due to health problems they have. For this reason, newborns should be placed in a sterile environment at a constant temperature where care parameters such as temperature, humidity and oxygen are kept in a controlled manner in order to protect their current health conditions and prevent worsening of their health, in other words, they need fresh air purified by passing through an antibacterial filter with a certain humidity and a quiet environment where their sleep will not be interrupted.

Approximately one million children die each year due to premature birth complications, and many of the survivors have to continue their lives with problems such as learning difficulties, visual and auditory damage [1], One of the most common premature birth complications is respiratory problems. In the literature, there are many studies on newborns needing special care in the Neonatal Intensive Care Unit (NICU) until their respiratory conditions are regulated [2], It is vitally important for newborns to be in the Neonatal Intensive Care Unit (NICU) under appropriate and controlled environmental conditions where parameters such as temperature, humidity, and oxygen are kept in a controlled manner in the first phase of their lives. However, the environmental conditions required for newborns to continue their lives healthily should be provided correctly by the incubators in which they are placed, and the controls of the incubators should be carried out periodically within the conditions specified in the IEC 60601-2-19:2009 standard [3],

Improper incubator controls can lead to inaccurate measurement of vital signs of newborns and, as a result, many different morbidities. Incubator calibrators are used to control the incubator environment and thus evaluate the vital signs of newborns. Thanks to these devices, it can be checked whether the ambient conditions provided by the incubators operate within the ranges specified in the IEC 60601-2-19:2009 standard. Mainly measured parameters in baby incubator calibrators are temperature, humidity, airflow rate and sound pressure level [3], However, it is suggested that in addition to the basic parameters, oxygen concentration, pressure value and light intensity should also be measured [4],

The main physical parameters affecting the environment in the incubators used to create the environmental conditions determined by the standard for newborns and to control these conditions are temperature, humidity, oxygen concentration, sound pressure level and light intensity.

Temperature: Temperature is one of the most important factors affecting newborns. Newborns have difficulty in regulating and controlling their body temperature. The temperature of the mother's uterus is 38 °C and newborns who find themselves in a colder environment after birth begins to lose heat. If heat loss cannot be prevented, hypothermia occurs. The body temperature of newborns should not fall below 36.5 °C [5], Failure to control severe hypothermia is an important and urgent condition that poses a life-threatening risk. Hypothermia can cause serious neonatal infections and mortality as a comorbidity of preterm delivery and asphyxia [6], The consequences of persistent hypothermia are metabolic acidosis, increased oxygen consumption, hypoglycemia, brain damage, decreased oxygen diffusion to tissue, and increased mortality [7], To protect newborns from diseases due to the inability to control their body temperature, it is necessary to set the temperature value of the environment in the incubator correctly and to ensure that the adjusted temperature value is correct. Temperature measurements should be made at five different points per the standard [3], To control the homogeneous distribution of these measurements, the temperature difference test should be applied.

Humidity: Humidity is water vapor in the air. In order to keep the body temperature constant, the balance between heat production and heat loss must be well maintained. The most important factor in ensuring the heat balance is the amount of humidity in the environment. Evaporation occurs when the amount of moisture in the environment increases. Evaporation is the state of heat loss by the transfer of water from the skin to the external environment. Evaporation is one of the main causes of heat loss in premature newborns during the first week. In order to reduce heat loss by evaporation in newborns, the humidity rate in the incubator should be adjusted correctly. In studies, it was observed that water loss from the skin decreased by increasing the humidity in the incubator in preterm and low-weight newborns [8], Differences in skin maturation of premature babies vary depending on gestational and post-gestational age. The stratum corneum, the outermost layer of the epidermis, is an important barrier for water loss and preventing the entry of agents from the outside into the organism. The stratum corneum continues to mature structurally from week 24 to week 34. In infants bom before 32 to 34 weeks, the risk of infection, transepidermal water loss, temperature irregularity, absorption of tropical agents, or physical trauma may occur due to the immaturity of the "stratum corneum" [9], In order for newborns to continue their lives comfortably, it is necessary to control the humidity in the incubator correctly.

Oxygen Amount and Pressure: The use of oxygen gas in the treatment of oxygen deficiency for newborns is a very effective and frequently used treatment method. It is vital to monitor the use of oxygen, which is an offensive drug. Because the lack (hypoxia) or excess (hyperoxia) of oxygen causes serious diseases in the newborn. In the literature, there are studies stating that inappropriate use of oxygen causes diseases such as aging, DNA damage, cancer, retinopathy of prematurity, bronchopulmonary dysplasia, damage to brain development, and infection [10, 11], Premature retinopathy is seen when preterm and low- weight neonates are exposed to high oxygen concentrations [12, 13], In the 1950s, it was aimed to reduce retinopathy of prematurity by reducing oxygen therapy, but oxygen restriction caused mortality and morbidity [14, 15], These studies show the importance of monitoring the amount of oxygen. Oxygen is one of the most basic parameters to be followed for a newborn. In this study, an oxygen sensor was added to the incubator calibrator to measure the oxygen content of the environment, so it was aimed to prevent and control hypoxia or hyperoxia in newborns who mostly breathe spontaneously. The damaging effect of oxygen gas on tissues is related to its partial pressure rather than its density. Thus, high concentrations of oxygen gas delivered at high altitudes are less harmful than oxygen gas delivered at sea levels [16],

A-weighted Sound Pressure Level (dBA): Sound pressure level is measured in decibels, which is a logarithmic scale. A-weighting is filtering that simulates human hearing characteristics. In the auditory environment in NICU, there are both desired and unwanted sounds. Noise, defined as unwanted, unpleasant sound, is ubiquitous in our environment. Sound is one of the most important parameters for the healthy development of the newborn and is an important stimulus for brain development that starts from the fetal period and continues in the newborn period. After birth, the newborn's brain is still developing and remains vulnerable. High levels of noise that newborns are constantly exposed to in neonatal intensive care units can cause permanent neurological damage, increase in heart rate, sleep disturbances, decrease in oxygen saturation, increase in heart rate, crying, and overreaction to stimuli (irritability) due to tension and stress [17, 18], Newborns exposed to loud noise may have distractibility when they reach childhood [17], In experiments on rats, early exposure to high noise levels (70 dB) has been shown to delay maturation of the auditory cortex [19], In a study supporting this, newborns exposed to less sound pressure levels showed increased growth, mental development, better weight gain, better sleep, and oxygen saturation compared to those exposed to higher sound pressure levels [20], In newborn care units, where the sound pressure level is variable, more precise measurement is of great importance in order to prevent health problems that may occur in the newborn. In order to avoid these health problems, it is recommended that the sound pressure level of newborns in their environment should not exceed a certain level and that this should be followed up regularly.

Light Intensity: In the NICU, newborns are exposed to high and variable light intensity such as 600 lux - 900 lux [21], but the recommended maximum light intensity is 646 lux [22], In a study on baboons, it was seen that light has a great effect on the circadian rhythm, that is, the biological clock [23], It has been proven that the suprachi asmatic nucleus, which is responsible for the circadian rhythm, is photosensitive in the early premature stages of primates, and this sensitivity is mediated through the retina [23], The light sensitivity of the suprachiasmatic nucleus indicates that light is the main rhythm regulator. The suprachiasmatic nucleus sleepwake cycle controls the secretion of growth hormone, cortisol and melatonin hormones. The hormone melatonin, whose synthesis and release into the circulation occurs during the dark hours and is inhibited by light; is a powerful antioxidant known to be involved in the regeneration of cells, strengthening the immune system, regulating sleep rhythm and body temperature [24], Continuous exposure to light in neonatal care units can have negative effects on the growth and development of the newborn, sleep pattern, circadian rhythm, body temperature protection, and nutrition. In addition, light can cause retinal damage and photophobia. It has been observed that lighting the neonatal unit in accordance with the day and night cycle contributes to both the physical and behavioral development of the newborn [25], The light and dark cycle in the external environment is important in the regulation of the circadian rhythm. However, it is known that sleep regulation has an important effect on neurosensory and cortex development [26], It is seen in studies that exposure to high intensity and continuous light negatively affects newborn development. In the NICU, which is illuminated with artificial lighting, the level of illumination must be controlled and measurable in order to maintain the circadian rhythm and develop neurosensors and cortex in the newborn.

Within the scope of this study, a baby incubator measurement and calibrator device was developed in accordance with the IEC 60601-2-19:2009 standard. Production stages are shared in detail in the following sections. In addition to performing the tests specified in the standard, the developed device can also measure parameters such as temperature, humidity amount, oxygen concentration, sound pressure level and light intensity of the ambient conditions of the baby incubator environment, which are proven to have a direct effect on newborn health. Furthermore, the developed device provides the opportunity to calibrate the baby incubators by comparing these own measured parameters with the parameters measured by the baby incubators themselves. The device can be used in instant measurement mode or can be used in calibration mode. It can keep the data of the calibration in its memory and makes it possible to access these data with the developed interface. With its unique device-specific design, incorrect positioning of the sensors has been prevented, thus minimizing the user-induced uncertainty components that may occur during the measurements. Another important property of the device is its fast installation. While calibrating the developed device, calibration adjustment can be made with the adjustment function. In addition, the infrastructure of the device is designed to be suitable for simultaneous calibration of more than one baby incubator. In hospitals, baby incubators are usually full and a long time should not be spent for the calibration process. Thanks to the developed device, the baby incubator calibration process (data recording ability) can be done quickly.

Another property of the invention is that it is a portable device. In other words, with this invention, the calibration of baby incubators can be performed with the device, which is the subject of the present patent, produced in a portable design. When the literature related to baby incubator calibrators is examined, the following documents, including the known state of the prior art, containing inventions similar to the invention subject to the current patent application, were found.

Patent document numbered CN110368237A and entitled as “Baby incubator monitoring system” is related to the technical field of baby incubators and in particular to an baby incubator monitoring system. The monitoring unit consists of a first temperature sensor, a humidity sensor, a noise monitoring sensor, an oxygen sensor, and a load cell assembly. The baby incubator monitoring system invention states that it can simultaneously detect parameters such as temperature, humidity, oxygen concentration, noise level and baby weight, and obtain comprehensive environmental and baby sign data. But, it is not possible to measure these parameters due to the absence of ambient pressure sensor and light sensor in the invention subject to the aforementioned patent, as in the current patent application. At the same time, there is no information about the calibration of the baby incubators in the aforementioned document.

Utility model document numbered CN203981203U and entitled as “Baby incubator automatic calibration device capable of positioning sensors accurately” is related to a baby incubator autocalibration device that can accurately position sensors. The device consists of a large number of flexible pipes for positioning. The device uses helix lines and positioning flexible pipes to fasten the sensors. According to the JJF1260-2010 Baby Incubator Calibration Specification, the baby incubator is required to detect parameters such as temperature, humidity, oxygen and noise, and the temperature sensor must be placed at five points like A, B, C, D and E. Here, A is at the center of the test, and the other four points are at the center of the four areas divided by the long and wide centerline, and the fifth point must be in a plane 10 cm above the surface. The temperature sensor can be positioned correctly. The incubator auto-calibration device uses a spiral wire and a positioning hose to fix the sensor. From the invention of the baby incubator automatic calibration device, which can position the sensors correctly, it is understood that the device can measure parameters such as temperature, humidity, oxygen concentration, and noise level/sound pressure level according to the specified standard. It is understood that this utility model and the device subject to the current patent application use a similar standard in terms of temperature sensor positioning and calibration capability. However, it is not possible to measure these parameters due to the absence of ambient pressure sensor and light intensity sensor in the invention subject to the aforementioned patent, as in the current patent application. Patent document numbered CN206583547U and entitled as “Wireless baby's incubator automatic correcting device data acquisition system” is related to data acquisition system of wireless baby incubator automatic calibration device. The device consists of a chip, a temperature sensor, a humidity sensor, an oxygen sensor, a noise sensor, an RS232 communication module, an AD sampling module and a driver module, a touch screen, a power module, a WIFI module, and a host computer. Its document indicates that the chip is embedded in the software. It is understood that the device, which is the subject of the invention, titled “wireless baby's incubator automatic correcting device data acquisition system”, can measure parameters such as temperature, humidity, oxygen concentration, and noise level. In the device subject to the present patent, besides the sensors in the patent number CN206583547U, there are also ambient pressure and light intensity sensors.

Patent document numbered CN203929750U and entitled as “Environment quality detection and calibration testing device for baby incubator” is related to environmental quality test and calibration device. It is stated that the device has sensors such as oxygen content, temperature, humidity, noise sensors in a box, these sensors are electrically connected to an industrial computer, it has a display screen and a printing device for the output data of the sensors, and the data can be printed on paper with the printing device. It is understood from the invention entitled “environmental quality detection and calibration testing device for baby incubator” that the device can measure parameters such as oxygen content, temperature, humidity, and noise level/sound pressure level. In the device subject to the current patent application, besides the sensors included in the invention in the patent numbered CN203929750U, there are also ambient pressure and light intensity sensors.

Patent document numbered CN203893888U and entitled as “Infant incubator environment state detection instrument ” is understood that it is an environmental status detector of a baby incubator and it consists of temperature, humidity, oxygen content and noise sensors, data acquisition cards and a transducer. It is understood from the invention entitled “infant incubator environment state detection instrument” that the device can measure parameters such as temperature, humidity, oxygen content and noise. In the device subject to the current patent application, there are also ambient pressure and light intensity sensors in addition to the sensors included in the subject invention in the patent numbered CN203893888U.

However, the list of other patent documents encountered in the state of the prior art is as follows:

United States patent document numbered US 1933733 and entitled as “Infant Incubator”, United States patent document numbered US2243999 and entitled as “Baby Incubator and the Like”,

United States patent document numbered US2470721 and entitled as “Portable Infant Incubator”,

United States patent document numbered US2598532 and entitled as “Infant Incubator Equipment”,

United States patent document numbered US2641248 and entitled as “Portable Baby Incubator”,

United States patent document numbered US3326203 and entitled as “Infant Incubators”,

United States patent document numbered US3782362 and entitled as “Baby Incubator”,

Chinese patent document numbered CN201764990U and entitled “Multi -parameter multi - terminal wireless controlled baby incubator detection system”,

Chinese patent document numbered CN202614402U and entitled “Zigbe-based baby incubator temperature monitoring and alarm system”,

The patent document numbered WO2016/175717A1 and entitled "Oxygen Controlled Baby Incubator Automized According to Targeted Oxygen Saturation”,

Like all the other patent documents examined above are generally related to measurement devices in incubators.

During the studies carried out for the invention that is the subject of the current patent application, it was studied on device with two different designs. Both designs are a design designed as a portable type. However, as shown in Picture 1 below, the instrument panel was designed as a separate part in the first design. In the second design, the instrument panel is enclosed in the bottom main body. Prototypes were produced for both of two different designs.

Picture 1. First Prototype Designed and Produced, First Design

The second design as the invention subject to the present patent application is as shown in between Figure 1 and Figure 8. Thanks to the invention, which is the subject of the current patent application, measurement of the parameters such as temperature, humidity amount, oxygen concentration, sound pressure level and light intensity of the baby incubator environment, which has vital importance for the care of newborns, can be carried out in accordance with the IEC 60601-2-19:2009 standard. The device subject to the current patent application, which is metrologically traceable, measures parameter values (temperature, humidity, pressure, oxygen concentration, sound pressure level, light intensity) as determined by standards, with low standard deviation values and high accuracy. At the same time, calibration of baby incubators with the device subject to the current patent application are completed by comparing the values measured by the baby incubator and values belongs to the device subject to the current patent application for parameters such as ambient temperature, oxygen concentration, sound pressure level, ambient pressure, humidity amount and light intensity.

With this developed device, health institutions and/or calibration laboratories will be able to perform calibration and/or verification tests of baby incubators at their workplaces in a comfortable, easy, fast, practical and portable way.

References

1. Organization, W.H. Preterm birth 2015. February 03,2016 07.11.2019] ; Available from: http://www.who.int/mediacentre/factsheets/fs363/en/ 2. Outcomes for premature babies an information booklet for parents. 2009 29.11.2019; Available from: https ://www. schn. health, nsw.gov. aufiles attachments pcf update and recenl version of out comes o premature babies booklet 2006.pdf.

3. Institution, T.B.S., Medical Electrical Equipment, in Particular Requirements for the Basic Safety and Essential Performance of Infant Incubators. 2009. p. 23.

4. Ozdemirci, E., et al., Reliability assessments of infant incubator and the analyzer. Gazi University Journal of Science, 2014. 27(4): p. 1169-1175.

5. Mittal, H, L. Mathew, and A. Gupta, Design and development of an infant incubator for controlling multiple parameters. Int J Emerg Trends Electr Electron, 2015. 11: p. 65-72.

6. Lunze, K., et al., The global burden of neonatal hypothermia: systematic review of a major challenge for newborn survival. BMC Medicine, 2013. 11(1): p. 24.

7. Heimann, K., M. Schoberer, and T. Orlikowsky, Thermomanagement in Neonatology and Paediatrics: Clinical Problems and Challenges. Biomedical Engineering/Biomedizinische Technik, 2013.

8. Kosa, E. and N. Qrnar, PREMA PURE BEBEKLERDE HiPOTERMiNIN ONLENMESI: PLASTIK ORTU KULLANIMI. Bahkesir Saghk Bilimleri Dergisi. 3(3): p. 161-165.

9. CAIJSIR, H. andF. GULER, Riskli Yenidoganlarm Cilt Bakiminda Kamta Dayah Uygulamalar. Turkiye Klinikleri Hemsirelik Bilimleri, 2011. 3(2).

10. Sola, A., M.R. Rogido, and R. Deulofeut, Oxygen as a neonatal health hazard: call for detente in clinical practice. Acta Paediatrica, 2007. 96(6): p. 801-812.

11. Hildebrand, W., et al., Use and abuse of oxygen in the newborn. American family physician, 1978. 18(3): p. 125-132.

12. Kinsey, V.E., J.T. Jacobus, andF. Hemphill, Retrolental fibroplasia: cooperative study of retrolental fibroplasia and the use of oxygen. AMA archives of ophthalmology, 1956.

56(4): p. 481-543. 13. Lanman, J.T., L.P. Guy, and J. Dancis, Retrolental fibroplasia and oxygen therapy. Journal of the American Medical Association, 1954. 155(3): p. 223-226.

14. Avery, M.E. and E.H. Oppenheimer, Recent increase in mortality from byaline membrane disease. The Journal of pediatrics, 1960. 57(4): p. 553-559.

15. McDonald, A.D., Cerebral palsy in children of very low birth weight. Archives of disease in childhood, 1963. 38(202): p. 579.

16. Hekimoglu, A., Terapotik Gazlar: Oksijen, Karbondioksit, Nitrik Oksid Ve Helyum. Dicle Tip Dergisi, 2007. 34(1): p. 61-69.

17. Marik, P.E., et al., Neonatal incubators: A toxic sound environment for the preterm infant? Pediatric Critical Care Medicine, 2012. 13(6): p. 685-689.

18. EAH, G.T., Yenidogan Yogun Bakim Unitesindeki Premature Bebegin GeHsiminin Desteklenmesi.

19. Chang, E.F. andM.M. Merzenich, Environmental noise retards auditory cortical development, science, 2003. 300(5618): p. 498-502.

20. Turk, C.A., A.L. Williams, andR.E. Lasky, A randomized clinical trial evaluating silicone earplugs for very low birth weight newborns in intensive care. Journal of Perinatology, 2009. 29(5): p. 358.

21. Lotas, M., Effects of light and sound in the neonatal intensive care unit environment on the low -birth-weight infant. NAACOG's clinical issues in perinatal and women's health nursing, 1992. 3(1): p. 34-44.

22. Pediatrics, A.A.o., A.C.o. Obstetricians, and Gynecologists, Guidelines for perinatal care. 2002: Amer Academy of Pediatrics.

23. Hao, H. and S.A. Rivkees, The biological clock of very premature primate infants is responsive to light. Proceedings of the National Academy of Sciences, 1999. 96(5): p. 2426- 2429.

24. Ozqelik, E, et al., Melatonin: Genel ozellikleri ve psikiyatrik bozukluklardaki rolii. Psikiyatride Giincel Yaklasimlar, 2013. 5(2): p. 179-203. 25. Miller, C.L., et al., The effects of cycled versus noncycled lighting on growth and development in preterm infants. Infant Behavior and Development, 1995. 18(1): p. 87-95.

26. Taga, G., et al., Hemodynamic responses to visual stimulation in occipital and frontal cortex of newborn infants: a near-infrared optical topography study. Early Human Development, 2003. 75: p. 203-210.

Technical Problem that Invention Aims to Solve

In the literature reviewed and similar devices available in the market, a limited number of physical parameters such as temperature, sound pressure level and air flow rate are generally measured. In the invention, which is the subject of the current patent application, in addition to the mentioned parameters, environmental parameters such as oxygen concentration, light intensity, atmospheric pressure and humidity can also be measured. So, since the devices in the state of the prior art do not contain ambient pressure and light intensity sensors, they cannot measure the pressure of the environment and the light intensity in the environment. Thanks to the device subject to the current patent application, the temperature, sound pressure level, humidity and oxygen level of the environment can be measured at the values specified in the IEC 60601-2-19:2009 standard, as well as the pressure of the environment and the intensity of the light in the environment. Furthermore, the quick, easy openable-foldable and portable design of the device that is the subject of the current application, which can measure the specified parameters as specified in the standard, makes the device unique compared to its competitors in the market. At the same time, the device that is the subject of the invention allows the calibration of the baby incubators by comparing its own measured values with the values measured by the baby incubators, thanks to its ability to keep the measurement results in its memory. The device which is the subject of the invention also facilitates the calibration process with its user-friendly interface within the metrological traceability chain. The baby incubator measurement and calibrator device, which is the subject of the present patent application, has had a use as described in the current patent application for the first time to the best of our knowledge in the state of the prior art. Description of the Drawings

The baby incubator measurement and calibrator device subject to the present patent application is explained in the attached figures, but the figures given are not limiting for the device subject to the invention;

Figure 1 - Cross-Front General View of the Device

Figure 2 - Cross-Rear General View of Device

Figure 3 - Cross-Top General View of the Device

Figure 4 - Cross-Bottom General View of the Device

Figure 5 - Detailed Cross View of the Device

Figure 6 - Detailed Top View of the Device

Figure 7 - Detailed Rear and Bottom View of the Device

Figure 8 - Detailed Inside View of the Device

Description of References in the Drawings

The parts in the figures are numbered one by one and the corresponding numbers are given below.

(200) Detailed Cross-Front View of the Device

(201) Top Main Body of the Device

(202) Bottom Main Body of the Device

(203) TFT Screen / Touch Screen

(204) Electronic Processor, Cards and Electronic Elements

(205) Temperature Sensors

(206) Oxygen Sensor

(207) Noise Level Sensor / Sound Pressure Level Sensor

(208) Pressure Sensor

(209) Humidity Sensor

(210) Light Intensity Sensor

(211) Connection Cable (212) USB-TTL

(213) USB-B Breakout

(300) Detailed Top View of the Device

(301) Sensor Top Cover

(302) Nested Extendable Arm

(303) Extending Telescopic Arms

(304) Hinges

(400) Detailed Rear and Bottom View of the Device

(401) Top Main Body Bottom Cover

(402) Cable Entry

(403) Battery Box Cover

(404) Temperature Sensor and Its Aperture for Bed Temperature Measurement

(405) Bottom Main Body Lower Cover

(500) Detailed Inside View of the Device

Description of the Invention

The device, which is the subject of the invention, is a designed and developed compact portable device in order to measure the temperature, oxygen concentration, sound pressure level, pressure, humidity amount and light intensity of the baby incubator environment in accordance with the IEC 60601-2-19:2009 standard, and to calibrate the baby incubators by comparing its own measured values with the values measured by the incubators themselves. Thanks to the portable design of the said calibrator device, which is designed to work with six types of main sensors on it, the measurement of the parameters of the baby incubator environment that are important for the health of the newborn and/or the calibration of the incubators can be performed on-site (inside the incubator) in a practical, fast and accurate manner.

The present invention comprises at least one temperature, at least one humidity, at least one oxygen, at least one sound pressure level, at least one light intensity and at least one pressure sensor that enables the measurement of baby incubator’s parameters and provide the calibration of the baby incubator. In an embodiment of the device subject to the invention, there are 2-8 pieces, preferably 3 or 4, more preferably 5 or 7, more preferably 6 pieces temperature sensors, 3-5 pieces, preferably 4 pieces humidity, 3-5 pieces, preferably 4 pieces oxygen concentrations, 3-5 pieces preferably 4 pieces sound pressure levels, 3-5 pieces preferably 4 pieces lights and 3-5 pieces preferably 4 pieces pressure sensors.

In one embodiment of the invention, there are 6 pieces temperature sensors, two pieces humidity, two pieces oxygen concentration, two pieces sound pressure level, two pieces light and two pieces pressure sensors in the baby incubator measurement and calibrator device.

The device is a compact device consisting of two main components that can be easily mounted to each other. Temperature, humidity, oxygen concentration, sound pressure level, light and pressure sensors are located on the first main part, and furthermore this structure, which forms the main structure of the device, has extendable and foldable arms containing temperature sensor(s). The nestable arms can then be easily mounted on the body. In addition, there are temperature sensor(s) in the center and at the bottom of this main part to measure the bed temperature by contacting the bed. Since temperature measurement is the most basic parameter in baby incubators, this developed unique design prevents the incorrect positioning of temperature sensors, thus minimizes the user-induced temperature uncertainty component that may occur during measurements. Another main component of the device is that it works as mountable with the body and there is a TFT display, electronic processor and various electronic elements and power unit on it.

In another embodiment of the invention, there are six pieces temperature, one piece humidity, one piece oxygen concentration, one piece sound pressure level, one piece light and one piece pressure sensor on the first main part. In this embodiment, four pieces temperature sensors can be located at the nested and in the foldable arms, one of the other two pieces temperature sensors is in the center of this main part and the other one is at the bottom of this main part to measure the bed temperature by contacting the bed.

The developed device performs the tests specified in the IEC 60601-2-19:2009 standard, and it can also measure the parameters of other environmental conditions that have a direct impact on newborn health. The device can be used in instant measurement mode, it can calibrate the baby incubators, in other words, it can keep the data of the calibration in its memory, and it is possible to access these data with the developed interface.

Furthermore, the sensors on the device are metrologically traceable. In this way, the calibration process is carried out by comparing the measurement data on the TFT screen of the device with the sensor values (temperature, humidity, etc.) on the baby incubator device. With the software on the device, the data can be displayed both on the TFT screen and, if desired, can be transferred to the computer as data with the developed software interface.

The dimensions of the device are preferably 600 mm, 300 mm and 155 mm (as width at full arm opening x depth x height), respectively. When the arms are in the closed position, the diameter of the top main and bottom main body of the device is preferably 150 mm, and the height is preferably 155 mm. The device is in the measurement position with the arms in the open position, but the arms can be easily folded and later easily mounted on the body.

The temperature sensors on the device are in the range of -40 °C to +125 °C, with a resolution of ± 0.0625 °C, with an accuracy of ± 0.25 °C; humidity sensors measure humidity amount as 0.1% to 100% with an accuracy of ± 3%; pressure sensors measure pressure values in the range of 300 kPa to 1100 kPa; oxygen sensors measure the amount of oxygen concentration in the range of 0.1% to 100%, sound pressure level sensors measure the amount of sound pressure between 30 dB and 120 dB; and light intensity sensors can measure light intensities between 0 lux and 65535 lux.

The device is metrologically traceable. The working principle of the invention is as follows. The device is placed in the baby incubator with the arms and the bottom main body as open. Three main operations can be performed on the TFT screen as the command control software. These are Real Time Measurement, Incubator Calibration, and Test and Adjust. Real Time Measurement allows all parameters coming from the sensors within the incubator calibrator device to be measured and thus provides data to be observed instantly. On the Real Time Measurement screen, the temperature data from the temperature sensors on the arms and body of the device and the bed temperature taken by the temperature sensor from the area of the device in contact with the bed, light intensity, sound pressure level, pressure, humidity and percentage of oxygen concentration can be read. With the Incubator Calibration command, one of the commands on the device, all parameters in the baby incubator are measured and recorded, and the calibration of the baby incubators is done by comparing with the values measured by the incubator calibrator; At the same time, it is ensured that the measurement results can be made reportable. From the Test and Adjustment tab, the warm-up, temperature difference test and sound pressure level tests specified in the IEC60601-2-19:2009 standard can be performed.

The basic working principle of the device is as follows:

The device is placed in the newborn baby incubator in the open position. In the open position, the nested extendable arms (302) and the extending telescopic arms (303) on the top main body

(201) of the device are brought into the opening position by means of the hinges (304). Located on the top main body (201) of the device; temperature sensors (205) provide temperature data, oxygen sensor(s) (206) provide oxygen concentration, sound pressure level sensor(s) (207) provide sound pressure level, pressure sensor(s) (208) provide ambient pressure level, humidity sensor(s (209) provide humidity, and the light intensity sensor(s) (210) collects the light amount in the form of electrical signals and sends it to the processor. Likewise, the temperature sensor(s) (205) on the bottom surface in contact with the newborn baby incubator bed on the bottom main body (202) of the device collects the bed temperature data it detects and sends it to the processor. This information transmission takes place via the electronic processor, the cards to which the sensors are connected, and the electronic elements (204). All collected information is compiled by software and transmitted to the user with the touch TFT screen (203) on the bottom main body (202). The top main body (201) and the bottom main body (202) of the device are connected to each other with the connection cable (211). On the top main body of the device, there are two pieces USB input elements (212, 213) to export the collected data. On the top main body of the device, there is a sensor top cover (301) in order to replace the malfunctioning sensors. On the lower part of the top main body of the device, there are top main body bottom cover (401), cable entry (402) and battery box cover (403). The device can supply its energy both through the device it is connected to and the battery on it. On the bottom main body of the device, only the bottom main body lower cover (405) is located. The connection cable (211) of the device can be put between the top main body (201) and the bottom main body

(202) when the process is completed. In this way, the device becomes a single compact unit. In our invention, the fact that the device is a compact, portable and light-weight calibrator device, being made the calibration of the sensors within the traceability chain and being collected more parameters than the parameters required in the IEC60601-2-19:2009 standard constitute an advantage for the preferability of the device. In addition to this, the device allows calibration and traceability of the baby incubator with Incubator Calibration mode. Finally, the ability to take measurements beyond the requirements of the relevant standard (IEC60601-2- 19:2009) makes the product unique.

Industrial Applicability of the Invention With our invention, devices that can measure the ambient conditions of baby incubators in accordance with the IEC 60601-2-19:2009 standard and able to calibrate baby incubators by recording can be produced in series and offered to users.

Claims

CLAIMS A baby incubator measurement and calibrator device that enables the measurement of the parameters of newborn incubators and the calibration of the baby incubators, which comprises at least one temperature, at least one humidity, at least one oxygen, at least one sound pressure level, at least one sound pressure level, at least one light intensity and at least one pressure sensor. The baby incubator measurement and calibrator device according to claim 1, which comprises; device top main body, device bottom main body, tft/touch screen, electronic processor, cards and electronic elements, at least one temperature sensor, at least one oxygen sensor, at least one sound pressure level sensor, at least one pressure sensor, at least one humidity sensor, at least one light intensity sensor, connection cable, usb-ttl, usb-b breakout, sensor top cover, nested extendable arms, arm hinges, top main body bottom cover, cable entry, battery box cover, temperature sensor and its aperture for bed temperature measurement, and bottom main body lower cover. The baby incubator measurement and calibrator device according to claim 1, comprises; six pieces temperature, one piece humidity, one piece oxygen, one piece sound pressure level, one piece light intensity and one piece pressure sensor. The baby incubator measurement and calibrator device according to claim 3, having the appropriate connection infrastructure for the flow sensor. The baby incubator measurement and calibrator device according to claim 1 and claim 3, which comprises nested extendable arms. The baby incubator measurement and calibrator device according to claim 5, wherein the nestable arms can be removed and installed, and can be easily mounted on the body. The baby incubator measurement and calibrator device according to claim 5, wherein four of the six pieces temperature sensors are located in nested arms, one piece in the center of the main part and the other one in the bottom part of the main part so that it can make measurements by contacting the bed. The baby incubator measurement and calibrator device according to claim 1, wherein temperature sensors have a measurement capacity between -40 °C and +125 °C. The baby incubator measurement and calibrator device according to claim 8, wherein temperature sensors make measurement with a resolution of ± 0,0625 °C and an accuracy of ± 0,25 °C.

10. The baby incubator measurement and calibrator device according to claim 1, wherein the humidity sensor is a sensor that measures 0.1% to 100% humidity with an accuracy of ±3%.

11. The baby incubator measurement and calibrator device according to claim 1 wherein the oxygen sensor is a sensor that measures the amount of oxygen concentration in the range of 0.1% to 100%.

12. The baby incubator measurement and calibrator device according to claim 1, wherein the sound pressure level sensor is a sensor that measures the sound pressure amount between 30 dB and 120 dB.

13. The baby incubator measurement and calibrator device according to claim 1, wherein the light intensity sensor is a sensor that measures light intensities in the range of 0 to 65535 lux.

14. The baby incubator measurement and calibrator device according to claim 1, wherein the pressure sensor is a sensor that measures pressure values in the range of 300 to 1100 kPa.

15. The baby incubator measurement and calibrator device according to claim 1, wherein calibration adjustment can be made with the adjustment function while calibrating.

16. The baby incubator measurement and calibrator device according to claim 1, wherein the dimensions are preferably 600 mm, 300 mm and 155 mm (width at full arm opening x depth x height), respectively.

17. The baby incubator measurement and calibrator device according to claim 1, wherein, when the arms are in the closed position, the diameter of the top main and bottom main body of the device is preferably 150 mm, and the height is preferably 155 mm.

18. The baby incubator measurement and calibrator device according to claim 1, wherein said device has a touch TFT screen located on the bottom main body.

19. The baby incubator measurement and calibrator device according to claim 1, wherein it works as mountable with the body and includes a TFT screen, electronic processor, various electronic elements and power unit. 0. The baby incubator measurement and calibrator device according to claim 1 wherein it is making measurement on the basis of the IEC 60601-2-19:2009 standard. 1. The baby incubator measurement and calibrator device according to claim 1, wherein said device has three main operations: real-time measurement mode, calibration mode, and test and adjustment mode.

22. The baby incubator measurement and calibrator device according to claim 1, wherein the said device measures and reads of ambient temperature, bed temperature, light intensity, sound pressure level, pressure, humidity and percentage of oxygen concentration with the sensors it has in real-time measurement mode. 23. The baby incubator measurement and calibrator device according to claim 1, wherein said device enables baby incubator calibration by comparing the values measured with the sensors the device has in the calibration mode with the values measured by the baby incubators.

24. The baby incubator measurement and calibrator device according to claim 1, wherein said device realizes the warm-up, temperature difference test and sound pressure level tests specified in the IEC60601-2-19:2009 standard in test and adjustment mode.

25. The baby incubator measurement and calibrator device according to claim 1, wherein the said device is portable.