Technical Field

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.

State of the Art

The Turkish word "cerrahi" (surgical in English) means using hands. The phrase surgical operation, on the other hand, means the treatment of a disease with surgery in medicine. Surgical Site Infections (SSI) 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. Despite the measures like the ventilation of the operating room and improvements in sterilization methods, barrier measures, surgical techniques, and antibiotic prophylaxis, SSIs are still an important issue. Surgical instruments must be cleaned after each use to prevent surgical site infection. Depending on the type of operation, 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%. On the other hand, 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.

Today, 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. It is not used for cleaning flexible endoscopes, rubbers, silicones, motorized systems, optical and camera systems, and lamp cables. For the ultrasonic cleaning process, surgical instruments must be put in suitable containers in a way that they do not contact each other. The temperature of the solution to be used should be 40°C. Using appropriate detergent and the correct method prevents protein coagulation at high temperatures in the ultrasonic cleaning process. The high temperature facilitates the movement of the gas in the solution and increases the effect of ultrasonic maintenance. Detergents recommended for a lower temperature should be used when the process is performed at low temperatures. The presence of acid solutions in the ultrasonic cleaning process and cleaning various alloys at once may cause electrolysis and corrosion. After the procedure, the instruments should be rinsed manually or with a machine, using demineralized water. Today, 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. In the other method, 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. One of those rods is placed in the middle of the tank, and the other two at a distance of 5 cm from each end of the tank. The device is turned on for 10 minutes. Each aluminum foil should be perforated and wrinkled if the device had worked correctly. After, a visual inspection is used to verify if the device is working effectively. Today, the foil test method is the more common method. However, the foil test is not suitable for documentation as it does not have a compact form. On the other hand, this test only verifies whether the ultrasonic cleaner is working or not. It does not test the contamination. The fact that the contamination test is not performed increases the risk of infection or contamination of the instruments used in surgical operations.

Consequently, the necessity of an ultrasonic cleaner test device that eliminates the disadvantages of the present technique and the insufficiency of the existing solutions have made it necessary to make a development in the related technical field.

Brief Description of the Invention

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.

Based on the state of the art, 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.

The structural and characteristic features as well as all the advantages of the invention can be understood more clearly with the following figures and the detailed description that refers to the said figures; therefore, the evaluation is required to be made by taking these figures and the detailed description into account.

Short Description of Figures

This invention should be considered with the figures described below in order to understand the configuration and advantages with the additional components of the present invention.

Figure 1 ; The schematic overview of the test device,

Figure-2; The schematic overview of the aluminum foil on the frame.

Reference Numbers 10. Test device

11 . Frame

12. Foil

13. Test result notification section

14. Tester notification section

15. Date notification section

16. Set notification section

17. Rod hole

Detailed Description of the Invention

In this detailed description, 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. In the ultrasonic cleaning process, 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. At the point of the collapse, the temperature reaches 5000 °C and the pressure to hundreds of atmospheres, eventually forming shock waves. Ultrasonic cleaning occurs as these shock waves hit the surface of the instrument to be cleaned in the liquid with great speed and create a kind of brushing effect. Ultrasonic cleaning can be 16 times more effective than manual cleaning.

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. After the said test device (10) is removed from the ultrasonic cleaner, these sections are completed and the test device (10) showing the test result is stored.

In a preferred embodiment of the invention, the said test configuration is designed to feature two foils (12) on the same test device (10). In the said test units (10), gradual dissolution was achieved by using foils (12) of different thicknesses, one thicker and the other thinner. Thus, it was possible to measure the performance of the ultrasonic cleaner and determine whether sufficient ultrasonic cavitation was applied to the surgical instruments. 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.