WO2023229552A1 - Installation de test de dispositif de nettoyage par ultrasons - Google Patents

Installation de test de dispositif de nettoyage par ultrasons Download PDF

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Publication number
WO2023229552A1
WO2023229552A1 PCT/TR2022/051101 TR2022051101W WO2023229552A1 WO 2023229552 A1 WO2023229552 A1 WO 2023229552A1 TR 2022051101 W TR2022051101 W TR 2022051101W WO 2023229552 A1 WO2023229552 A1 WO 2023229552A1
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WO
WIPO (PCT)
Prior art keywords
test
frame
test device
cleaning
ultrasonic
Prior art date
Application number
PCT/TR2022/051101
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English (en)
Inventor
Umut Doğu KAYA
Original Assignee
Necati̇ Kaya Tibbi̇ Ci̇hazlar İthalat Ve İhracat Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Necati̇ Kaya Tibbi̇ Ci̇hazlar İthalat Ve İhracat Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ filed Critical Necati̇ Kaya Tibbi̇ Ci̇hazlar İthalat Ve İhracat Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
Publication of WO2023229552A1 publication Critical patent/WO2023229552A1/fr

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01H—MEASUREMENT OF MECHANICAL VIBRATIONS OR ULTRASONIC, SONIC OR INFRASONIC WAVES
    • G01H17/00—Measuring mechanical vibrations or ultrasonic, sonic or infrasonic waves, not provided for in the preceding groups
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/70—Cleaning devices specially adapted for surgical instruments
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B08—CLEANING
    • B08B—CLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
    • B08B3/00—Cleaning by methods involving the use or presence of liquid or steam
    • B08B3/04—Cleaning involving contact with liquid
    • B08B3/10—Cleaning involving contact with liquid with additional treatment of the liquid or of the object being cleaned, e.g. by heat, by electricity or by vibration
    • B08B3/12—Cleaning involving contact with liquid with additional treatment of the liquid or of the object being cleaned, e.g. by heat, by electricity or by vibration by sonic or ultrasonic vibrations

Definitions

  • the invention is related to a test device that neutralizes the impact of pressure and fluctuation in the water to obtain a more accurate measurement of results with the ultrasonic cleaner that is used in hospitals, oral and dental health centers, central sterilization units, and service companies to ensure that the instruments used during surgical operations are cleaned from all kinds of contaminants and residues that may cause infection in order to prevent infections that may occur before contact with the human body.
  • Surgical Site Infections are infections that develop in the relevant incision site, organ or space after an operation (procedure). These infections, which would not develop if the patient had not undergone the operation, are therefore associated with health care, that is, with the surgery performed. Risk factors for the development of SSI may be related to the health care service provided before, during, and after surgery. In recent years, we have seen some significant advances in infection control measures for SSIs.
  • Surgical instruments must be cleaned after each use to prevent surgical site infection.
  • surgical instruments may have blood, solutions, organic residues, and residues of chemical substances of different types on them after an operation. It is necessary to clean those residues and particles.
  • Pre-cleaning is one of the most important steps in the disinfection or sterilization of surgical instruments. Cleaning those using only water reduces the risk of infection by 50%.
  • cleaning the equipment with chemical agents is considered one of the essential steps for safety.
  • Organic residues on the instruments prevent safe sterilization as they increase the microbiological load.
  • Organic contamination prevents the contact of the sterilization agent with the instrument, thus rendering it ineffective. That makes a thorough pre-cleaning step extremely important.
  • the cleaning process may be performed using manual, automatic, or ultrasonic cleaner. Cleaning instruments with a machine delivers a longer service life to the instrument and provides a great advantage in terms of personnel health. Using a machine for cleaning the instruments also eliminates the need for pre-cleaning.
  • the pre-cleaning process is performed on the used surgical instruments before the sterilization process to remove all visible blood stains and residues from the human body, reduce the number of microorganisms on the instrument (this will make the sterilization process more effective and prevent the emergence of endotoxins from dead microorganisms), and to protect the instruments from corrosion.
  • One of the important points is to check whether the cleaner to be used in the pre-cleaning process has a corrosive effect on surgical instruments made of chrome steel, which is sensitive to corrosion.
  • Alkaline detergents which provide effective cleaning in automatic machines, may be used for pre-cleaning. Chlorine and chlorine (20 ppm) compounds can be used for cleaning and disinfecting at lower temperatures, but they may cause corrosive effects.
  • More sensitive instruments should be cleaned with mildly alkaline detergents with a pH of 8-10.
  • the quality of the water is also important for effective cleaning in the pre-cleaning phase.
  • the water used in the machine must be demineralized to prevent corrosion. Heavy metal ions (iron, copper, manganese) in water may discolor the instrument and create stains, like those discolored (brown, blue) spots after oxidation. Rubbing with acetic acid, phosphoric acid, or citric acid would remove these stains. However, that requires extra labor and time.
  • the instrument used in any invasive procedure is contaminated with tissues, blood, and body fluids. The lumened instruments are especially affected by this kind of contamination as they are filled with those wastes. These used and contaminated instruments must undergo another process before being used on another patient.
  • Cleaning constitutes the main phase of this process. Since organic residues on the instrument increase the microbiological load, safe sterilization is not possible without removing them. Organic residues contain proteins and these proteins stick to each other stronger at 50°C, causing coagulation and spreading over larger areas with the increase in temperature. This makes the pre-cleaning of surgical instruments the most important step of the sterilization and disinfection process.
  • the cleaning process is performed using manual, automatic or ultrasonic cleaner. Using a machine in the cleaning process delivers a longer service life to the instrument and provides a great advantage in terms of personnel health. Furthermore, using a machine eliminates the need for pre-cleaning. Ultrasonic means the vibration rate of high-frequency sound waves that humans cannot naturally hear.
  • Ultrasonic cleaners use ultrasonic waves of at least 35 kHz frequency for 3 minutes to clean the instruments. Those waves increase and decrease the pressure of the liquid rapidly. The sudden decrease in pressure results in the formation of gas bubbles in the water, which later burst with the increase in pressure. This movement resulting from gas bubbles is called cavitation. The vibration created by sound waves has the same effect as brushing.
  • Ultrasonic cleaners have a transducer that converts electrical waves into ultrasonic waves. This transducer is installed at the bottom of the cleaning tank containing the cleaning liquid. The said ultrasonic cleaner is used for cleaning stainless steel and precision instruments. It is a support device for cleaning harder stains to remove.
  • the instruments should be rinsed manually or with a machine, using demineralized water.
  • glass slide and foil tests are used for the inspection of ultrasonic cleaners. The glass slide test is performed by wetting the frosted part of the slide and drawing an “X” from corner to corner using a no. 2 pencil. Then it is immersed in the cleaning solution. After that, the device is turned on and the drawn mark is visually inspected. The test verifies that the device works effectively if the “X” mark begins to be removed immediately and disappears completely within 10 seconds.
  • the foil test three pieces of aluminum foil of 10X20 cm are cut. Each piece is folded over a rod and immersed in the tank.
  • the invention is related to a test device that meets the aforementioned needs, removes all the disadvantaged and adds a few new advantages, and that neutralizes the impact of pressure and fluctuation in the water to obtain a more accurate measurement of results with the ultrasonic cleaner that is used in hospitals, oral and dental health centers, central sterilization units, and service companies to ensure that the instruments used during surgical operations are cleaned from all kinds of contaminants and residues that may cause infection in order to prevent infections that may occur before contact with the human body.
  • the aim of the invention is to ensure more accurate measurement results by neutralizing the effect of pressure and fluctuation in the water, thanks to the rod put through the center to fix the developed test device.
  • An aim of the invention is to ensure that the ultrasonic cleaning device used in the cleaning of surgical instruments is subjected to both the foil test and the pollution test with the help of the test device.
  • Another aim of the invention is to minimize the risk of infection and contamination of the material by ensuring the performance of both aluminum foil and contamination testing.
  • Another aim of the invention is to report the results, thanks to the documentation feature of the test device, in addition to its measurement function.
  • Another aim of the invention is to enable the determination of the contamination rate by testing the ultrasonic cleaner in a shorter time and easily with the help of the test device.
  • Another aim of the invention is to reduce production costs as the test device is produced from plastic materials using the injection method.
  • Figure 1 The schematic overview of the test device
  • FIG-2 The schematic overview of the aluminum foil on the frame.
  • the invention related to a test device (10) that neutralizes the impact of pressure and fluctuation in the water to obtain a more accurate measurement of results with the ultrasonic cleaner that is used in hospitals, oral and dental health centers, central sterilization units, and service companies to ensure that the instruments used during surgical operations are cleaned from all kinds of contaminants and residues that may cause infection in order to prevent infections that may occur before contact with the human body is described only as an example for better understanding of the issue and without any limitation.
  • Ultrasonic cleaning is the process of removing contaminants from the instrument in the tank by applying high-frequency sound waves to the liquid-filled tank.
  • Devices that perform this process are called ultrasonic cleaners.
  • Ultrasonic cleaners have many uses and are produced in various types and sizes.
  • the material to be cleaned is placed in a liquid and cleaned with ultrasonic sound waves sent to the container with the liquid.
  • High-frequency sound waves are used to produce about 30,000 pressure changes per second, changing the pressure from high to low and vice versa. Sound waves produce millions of microscopic air bubbles. The air bubbles react to large pressure changes by first expanding, then contracting, and collapsing. These collapses release a great amount of energy.
  • the test device (10) shown in Figure-1 consists of a frame (11) made of plastic-based material using the injection method and an aluminum foil (12) stretched inside this frame (11), unlike the current method where the aluminum foil is wrapped over a pencil or similar object.
  • the feature of the mentioned test device (10) is neutralizing the effect of pressure and fluctuation in the water thanks to the rods put through rod holes (17) positioned on the frame (11). It allows fixing the frame (11) shown in Figure-2 with the rod put through the rod hole (17) positioned in the middle and yields a more accurate measurement of the results.
  • the mentioned test device (10) performs an aluminum foil test to determine the performance of the ultrasonic cleaner and a contamination test to determine if the surgical instruments are properly cleaned.
  • the mentioned test device (10) is placed in the ultrasonic cleaner together with the surgical instrument set to be cleaned. Scratches, tears, and/or holes occur on the foil (12) with the energy applied by the ultrasonic cleaner during the cleaning process. These scratches, tears, and/or holes formed on the foil (12) after the cleaning process inform us about the performance of the device and show whether adequate ultrasonic cavitation is applied to the surgical instruments.
  • a test result notification section (13) showing whether the cleaning process is successful or not, the tester notification section (14) showing the person carrying out the cleaning process, the test date notification section (15) showing the date the cleaning process was performed and the set notification section (16) showing the main field of use of the cleaned surgical instrument, such as orthopedics, general surgery, etc., were installed on the aforementioned frame (11) to record the information about the process and making the documentation after the cleaning process.
  • the test device (10) is removed from the ultrasonic cleaner, these sections are completed and the test device (10) showing the test result is stored.
  • the said test configuration is designed to feature two foils (12) on the same test device (10).
  • said test units (10) gradual dissolution was achieved by using foils (12) of different thicknesses, one thicker and the other thinner.
  • the double test device (10) method enables measurement of the performance of the device and the cleaning process at once, thus providing a more guaranteed result.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Physics & Mathematics (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cleaning By Liquid Or Steam (AREA)

Abstract

L'invention concerne un dispositif de test (10) mis au point pour tester des dispositifs de nettoyage par ultrasons, comprenant un cadre (11) réalisé dans un matériau à base de plastique à l'aide d'un procédé d'injection, sur lequel les informations de test sont enregistrées et une tige placée à travers le centre du cadre (11) pour neutraliser l'effet de pression et de fluctuation dans l'eau.
PCT/TR2022/051101 2022-05-24 2022-10-07 Installation de test de dispositif de nettoyage par ultrasons WO2023229552A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2022/008367 2022-05-24
TR2022008367 2022-05-24

Publications (1)

Publication Number Publication Date
WO2023229552A1 true WO2023229552A1 (fr) 2023-11-30

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Family Applications (1)

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PCT/TR2022/051101 WO2023229552A1 (fr) 2022-05-24 2022-10-07 Installation de test de dispositif de nettoyage par ultrasons

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117838249A (zh) * 2024-03-07 2024-04-09 江苏百宁盈创医疗科技有限公司 一种便于避免交叉感染的超声刀设备

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102042871A (zh) * 2010-10-22 2011-05-04 中国人民解放军海军潜艇学院 超声波清洗机性能的铝箔测试方法
TR201809927U5 (tr) * 2018-07-12 2018-07-23 Necati Kaya Tibbi Cihazlar Ithalat Ve Ihracat Sanayi Ve Ticaret Ltd Sirketi Ultrasoni̇k test ci̇hazi
CN211839175U (zh) * 2020-02-27 2020-11-03 茌平县七星医药包装材料有限公司 一种立式药用铝箔清洗机

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102042871A (zh) * 2010-10-22 2011-05-04 中国人民解放军海军潜艇学院 超声波清洗机性能的铝箔测试方法
TR201809927U5 (tr) * 2018-07-12 2018-07-23 Necati Kaya Tibbi Cihazlar Ithalat Ve Ihracat Sanayi Ve Ticaret Ltd Sirketi Ultrasoni̇k test ci̇hazi
CN211839175U (zh) * 2020-02-27 2020-11-03 茌平县七星医药包装材料有限公司 一种立式药用铝箔清洗机

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117838249A (zh) * 2024-03-07 2024-04-09 江苏百宁盈创医疗科技有限公司 一种便于避免交叉感染的超声刀设备
CN117838249B (zh) * 2024-03-07 2024-05-28 江苏百宁盈创医疗科技有限公司 一种便于避免交叉感染的超声刀设备

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