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Inspection and Testing of Pediatric and Neonate Incubators

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Inspection of Medical Devices

Part of the book series: Series in Biomedical Engineering ((BIOMENG))

Abstract

Infant incubators revolutionized the way medical care is provided to prematurely born infants or infants born with different kind of diseases and health problems. Due to development of technology infant incubators have been significantly improved from the time they were invented, but the main functions remained the same. Infant incubators provide optimal environmental conditions for infants to recover. This is achieved by controlling parameters such as temperature, relative humidity, air flow rate, oxygen concentration, suitable for medical treatment of certain conditions. Increased sophistication of medical devices, including infant incubators raises numerous questions regarding safety of device and reliability of controlled parameters within medical device. Regulatory bodies define requirements for infant incubators in manufacturing process, distribution and disposal. However, questions on requirements and methods for inspection of safety and performance of these devices are addressed more frequently. These inspections are most usually performed by trained clinical professionals who use specialized devices, analysers (phantoms). Using these calibrated analysers, traceability to international (SI) units of medical device measurement is ensured, which raises reliability of medical device treatment. This chapter describes types of infant incubators that are used in today’s healthcare system, as well as requirements on infant incubators stated in international standards and medical device directives. Description of infant incubator analysers is given at the end of this chapter.

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Abbreviations

AAP:

American Academy of Paediatrics

AAMI:

Association for the Advancement of Medical Instrumentation

AC:

Alternating current

ACOG:

American College of Obstetricians and Gynaecologists

CM:

Corrective maintenance

DC:

Direct current

FDA MAUDE:

US Food and Drug Administration Manufacturer and User Facility Device Experience Database

IEC:

International Electrochemical Commission

ISO:

International Organization for Standardization

NICU:

Neonatal intensive care units

PM:

Preventive maintenance

SI:

International System of Units

UNESCO:

United Nations Educational, Scientific, and Cultural Organization

UNICEF:

United Nations International Children’s Emergency Fund

UPS:

Uninterruptable power supply

UV:

Ultraviolet

WHO:

World Health Organization

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Author information

Authors and Affiliations

  1. Medical Devices Verification Laboratory, Verlab Ltd Sarajevo, Sarajevo, Bosnia and Herzegovina

    Lejla Gurbeta

  2. Clinical Center University of Sarajevo, Sarajevo, Bosnia and Herzegovina

    Sebija Izetbegović

  3. Canton Hospital Zenica, Zenica, Bosnia and Herzegovina

    Alma Badnjević-Čengić

Authors
  1. Lejla Gurbeta
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  2. Sebija Izetbegović
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  3. Alma Badnjević-Čengić
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Corresponding author

Correspondence to Lejla Gurbeta .

Editor information

Editors and Affiliations

  1. Verlab Ltd Sarajevo, Medical Devices Verification Laboratory, Sarajevo, Bosnia and Herzegovina

    Almir Badnjević

  2. Faculty of Electrical Engineering and Computing Zagreb, University of Zagreb, Zagreb, Croatia

    Mario Cifrek

  3. Faculty of Electrical Engineering and Computing Zagreb, University of Zagreb, Zagreb, Croatia

    Ratko Magjarević

  4. Institute of Metrology of Bosnia and Herzegovina, Sarajevo, Bosnia and Herzegovina

    Zijad Džemić

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© 2018 Springer Nature Singapore Pte Ltd.

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Gurbeta, L., Izetbegović, S., Badnjević-Čengić, A. (2018). Inspection and Testing of Pediatric and Neonate Incubators. In: Badnjević, A., Cifrek, M., Magjarević, R., Džemić, Z. (eds) Inspection of Medical Devices . Series in Biomedical Engineering. Springer, Singapore. https://doi.org/10.1007/978-981-10-6650-4_11

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  • DOI: https://doi.org/10.1007/978-981-10-6650-4_11

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  • Publisher Name: Springer, Singapore

  • Print ISBN: 978-981-10-6649-8

  • Online ISBN: 978-981-10-6650-4

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