Aspirating periosteal

Medical device for the maxillary
sinus-lift procedure

Conceived by Dr. Fabio Costa medical director at the Maxillofacial Surgery Clinic, Udine
Designed, manufactured and certified by DenTag srl.

INITIAL IDEA

Integrate in one medical device all actions that usually are carried out in different times or by several operators: maxillary sinus membrane elevation and aspiration of liquids.

ADDITIONAL SAFETY

Relevant decrease in the chances of damaging the sinus membrane caused by the inappropriate positioning of the suction cannula.

OUTCOMES

Greater safety during surgery, reduction of surgery duration and better view of the surgical intervention area.

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Tips size

Aspirating periosteal tips come in two sizes: 3.5 mm and 5.0 mm, to respond to different types of operation.


Aspiration hole

Aspiration hole is placed on the inside of the periosteal’s curve to prevent any damage to the membrane.


OR seals

OR seals made of a material resistant to sterilization’s high-temperatures.


Device components

The device consists of three separate components to facilitate and improve cleaning and sterilization procedures.


Operating instructions of the aspirating periosteal

(available in all packages)

Intended use:

Stainless steel aspirating periosteal elevators are reusable surgical devices, for clinical dentistry use only. They are used in maxillary sinus-lift procedure, during Schneider membrane elevation procedure. These aspirating periosteal elevators must be connected to a suction system. These are surgical instruments, therefore must exclusively be used by licensed dentists. The suction unit must comply with current regulations and maintained according to instructions.

Contraindications:

Because of the peculiarity of these devices, there are no known contraindications.

Instructions for use:

Aspirating periosteal elevators must be used according to recognized principles of correct dental practice. The suction on the working part of the periosteal elevator facilitates maxillary sinus lift operation, because the use of a suction cannula is no longer needed. The aspirating dissector must be connected to a suction system through the suction connecting tube, funnel/funnel, supplied with the kit.

Cleaning and disinfection:

The device is NON-STERILE when sold, therefore it must be carefully cleaned, disinfected and sterilized before use. To prevent excessive biological buildup or the risk of cross infections, the cleaning and sterilization procedures must be carried out before every use.

Immediately after use, rinse the device in running tap-water in order to remove larger debris. For an effective cleaning, divide the instrument in its three parts by unscrewing the two ends from the central component (handle), remove OR rubber seals, and immerse all elements in hot water for 10 minutes. Subsequently, carefully rinse all parts in running tap-water and use suitable brushes to clean insides. Accurately clean the suction hole on the working part, using a very thin soft bristle brush. Do not use metal bristle brushes nor steel wool. If possible, blow compressed air on the suction hole. Cleaning procedures should be carried out at the soonest after use, to prevent any damage to steel caused by blood residues, or obstruction of the aspirating hole due to blood clots. Check OR rubber seals for any damage and replace them, if needed. After rinsing, proceed with ultrasonic cleaning using an aldehyde-free cleanser/disinfectant (e.g. based on quaternary ammonium salts), strictly complying with concentrations recommended by the manufacturer. Immerse completely all parts in the solution. Comply with recommended concentration of the solution, frequency (34-50kHz), water temperature (approx. 50°C), and contact time (10 mins.). Subsequently, rinse instruments with distilled or sterile water and dry them. NOTE: Use personal protective equipment (gloves, protective mask, goggles etc.) at all time during the procedure.

Sterilization:

After cleaning and disinfection, verify that instruments are duly dried and put them in medical grade paper and transparent polyester/propylene pouches – like “Eurosteril pouches for sterilization” by EURONDA – that can be sterilized by steam, as stated by the manufacturer. Seal the envelope with a suitable heat sealer, at a temperature between 170° and 200° C, and put all pouches containing instruments in the steam autoclave. Sterilization must be done by steam in autoclave with a 134°C process for 3 minutes. Any other process should be validated by the user; however, it is recommended NEVER to exceed the temperature of 175°C, as it could damage the materials. After the sterilization, store each device in sterile containers, to avoid contamination. Store all pouches containing sterilized medical devices in a lightless environment, at a room temperature between +5° and +30°C, with a relative humidity < 50% and avoid direct exposure to heat sources. Before reusing the medical device, check the chemical pH indicator and the sterilization pouch: if damaged sterilize again. These cleaning and sterilization procedures can be repeated endlessly, as they do not cause deterioration of the device. The estimated life span of this device is usually determined by wear and damages caused by use and may vary from the user’s practical techniques. However, at least thirty operations are guaranteed (excluding OR rubber seals).

Before disposal of worn out devices, clean and sterilize thoroughly and then dispose according to applicable laws.

IU 33-01 rev.3, 3rd of April 2019

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