Euronda EM40 Aspirator Tip Instructions

Euronda EM40 Aspirator Tip

Product Information

Product Name: EM19, EM21, EM40 Aspirator Tip
Manufacturer: Euronda S.P.A.
Country of Origin: Italy
Date of Manufacture: 12.2022
Batch Code: 0051 REV. 07/2022
Medical Device: Yes
Catalogue Number: Consult instructions for use
Distributed by: UDI Code

Product Usage Instructions

1.  Wear protective gloves when using the EM19, EM21, and EM40 Aspirator Tip.
2. Wear protective goggles to protect your eyes.
3. Use a face mask for additional protection.
4. Use protective clothing to prevent contact with the product.
5.  Before use, prepare the treatment area by cleaning it with detergent wipes to remove organic dirt and transport the product from the treatment chair to the reprocessing area.
6. For manual cleaning, rinse, disinfection, and final rinsing, follow the instructions provided.
7. Protect the product from heat sources and moisture.
8.  Refer to the instructions for use for further information on the product.

Please note that these instructions are provided as a summary. For complete and detailed instructions, consult the official user manual provided with the product.

INTENDED USE
A rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of fluids, aerosols and debris during a dental procedure, thus ensuring a dry surgical field. The device can be sterilized and it is reusable.

USER
Only for use by dental personnel and qualified staff.

PATIENT TARGET GROUP
The aspirator tip is used in the context of an outpatient or surgical dental procedure on minors and adults, regardless of gender, including pregnant and breastfeeding women.

CHARACTERISTICS OF THE DEVICE

SPECIFICATIONS OF USE

• Consult the section of the Instruction for Use provided  with the dental unit or surgical aspirator related to the connection of the aspirator tip to the handpiece of the dental unit or surgical aspirator.
• Visually inspect the integrity of the product.
• Connect the cannula to the suction system tube of the dental unit or surgical aspirator, using an adapter if necessary.
•  Activate the suction system. The correct functioning implies the suction of fluids and aerosols only from the ending tip of the cannula, without further aspiration points, i.e. in the connection with the dental unit or from holes in the cannula itself. In such cases, stop using the device immediately and dispose of the unit.
• After use, handle the device as specified in the REPROCESSING INSTRUCTIONS.

WARNINGS

• The use of the device is contraindicated in patients with sensitivity or allergies to polypropylene.
• The mechanical action of rubbing the cannula on the inner mouth might cause irritation and superficial redness
• Devices are not sterile on delivery. Hence, before they are used the first time, and every time after each patient treatment, they must undergo complete REPROCESSING. Please refer to the REPROCESSING INSTRUCTIONS.
• Failure to comply with the REPROCESSING cycle exposes  to the risk of cross infection
• Before every use, the product must be visually inspected for any signs of wear or tear.
• In case of damage, the device must not be used and must be disposed of immediately.
• Collect and clean the device immediately after use. Dried or fixed residues can make cleaning more difficult or ineffective.
• Report any serious incident that has occurred to the manufacturer and to the competent authority.

SHELF LIFE OF THE DEVICE
Maximum 100 sterilization cycles.

DISPOSAL
If not sterilized after its last use, the device must be treated and disposed of as hospital waste, since cross infection risks might occur. Alternatively, the sterilized device may be disposed according to the national regulations.

REPROCESSING INSTRUCTIONS

Risk analysis and categorization
A risk analysis and categorization of this medical device must be performed before its reprocessing by the user. The user is responsible for the correct classification of the medical products, the definition of the reprocessing steps and the performance of the reprocessing.

Reprocessing procedure

• Comply with all national directives. standards and specifications for the cleaning, disinfection and sterilization of medical products as well as the applicable specifications for dental practices and clinics.
• The person conducing the reprocessing is responsible for ensuring that the reprocessing, performed using the adequate equipment, materials and personnel. achieves the desired results.
• The validation and routine monitoring of the reprocessing procedure are required; all devices used (ultrasonic bath, cleaning and disinfection device. sealing device, steam sterilizer) must undergo regular maintenance and inspections.
• Any deviation from the instructions described herein by the reprocessing staff could lead to lower effectiveness and possible negative consequences, which lie solely within staff responsibility.

The recommended reprocessing procedure consists of at least the following steps:

• Pre-cleaning.
• Manual cleaning, intermediate rinsing, disinfection, final rinse, drying.
• Automatic cleaning and disinfection.
• Check for function.
• Packing.
• Steam sterilization.
• Clearance of the device.
• Storage.

Pre-cleaning
RISK OF INFECTION FROM CONTAMINATED PRODUCTS

• Reprocess the device correctly and promptly before its first use and after every subsequent use

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Wear protective gloves.| Wear protective goggles.
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Use a face mask.| Use protective clothing.

Preparation at the point of use prior to reprocessing

• Directly after the treatment, aspirate at least 200 ml cold water.
• Sequentially wipe down the exterior surfaces with two cleaning wipes to remove coarse organic and inorganic soiling.
• The cleaning wipes shall be compatible with polypropylene.
• Instruction for use of the wipes shall be followed.
• Place the product in a special container with a cleaning and disinfectant agent.
• Instruction for use of the cleaning and disinfectant agent shall be followed.
• Protect the unit from contamination when transporting it from the treatment chair to the reprocessing location.

Manual cleaning, intermediate rinsing, disinfection, final rinse, drying

• A disinfectant or a combined cleaning and disinfectant agent is required for manual disinfection. It must have the following properties: certified, possibly virucidal efficacy (DVV/RKI, VAH or European Standards), aldehyde-free and suitable for use with polypropylene.
• Comply with the concentration, temperature, reaction time and post-rinsing specifications issued by the manufacturer of the cleaning and disinfectant agent.
• Use clean, dry, oil- and particle-free compressed air.
• Never use brushes with metal bristles.
• Select a cleaning brush with nylon bristles to clean the external surtace.
• Select a round cleaning brush with nylon bristles for aspirators to clean the inner surface
• Water shall have good microbiological quality (at least drinking water quality) and shall be at a temperature < 35°C.

Cleaning

• Place the device in a cleaning and disinfectant bath so that it is fully immersed.
• Comply with the reaction times of the cleaning and disinfectant agent.
• Brush all exterior and interior surfaces completely with a hygienic brush keeping the device immerged in the ready-to-use solution.

Intermediate rinsing

• After the reaction time prescribed by the manufacturer, rinse thoroughly under water for at least 1 minute until all residues have been removed.

Disinfection

•  Place the device in a cleaning and disinfectant bath so that it is fully immersed.
• Comply with the reaction time of the cleaning agent and disinfectant.

Final rinse

• After the action time prescribed by the disinfectant manufacturer, rinse thoroughly under water for at least 1 minute until all disinfectant residues have been removed.

Drying

• Dry at a clean location using a hygienic, lint-free cloth.
• Blow dry the device with compressed air in a clean location

Automatic cleaning and disinfection

• A certified washer-disinfector with the following properties and validated processes is required:
• compliant to EN ISO 15883
• certified program for thermal disinfection (A0 value ≥3000)
• program suitable for the device with at least one final rinsing cycle
• If the washer-disinfector uses chemical cleaning agents and disinfectants, the following properties are required: non-fixing and aldehyde-free, compatible with polypropylene. Manufacturer’s instruction for use  shall be consulted.

Automatic cleaning and disinfecting

•  Position the device using the suitable holders in the washer-disinfector, so that the water flows easily and rinses the inner surfaces.
• Follow the instruction for use of the washer- disinfector.

Check for function

• After the end of the cleaning and disinfection cycle, check the device for any residual soiling and moisture. If necessary, repeat the cycle.
• Dispose of the device if damaged.
• The device should be packaged as soon as possible after drying and checking.

Packing

• Select a certified sterile barrier system suitable for the product and the steam sterilization procedure:
• Reels or pouches made of paper and plastic film
• Temperature resistance up to 138°C
• Compliant with EN ISO 11607-1, EN 868-5
• The sterile barrier system must be large enough. Once it is loaded, the sterile barrier system must not be under strain

Steam sterilization

RISK OF INFECTION DUE TO INCORRECT STERILIZATION

• Only steam sterilization must be used.
• Comply with all of the specified process parameters.
• Comply with the manufacturer’s instructions regarding use of the steam sterilizer.
• A certified steam sterilizing unit with the following properties and validated processes is required:
• compliant with EN 13060 or equivalent suitable program for the products listed (for example hollow bodies, fractionated vacuum procedure in three vacuum steps)
• validated process in accordance with EN ISO 17665-1

Steam sterilization

• Position the packed device on the tray of the steamsterilizing unit following the instruction for use provided by the manufacturer of the sterilizer
• Select a B sterilization cycle
• Pre-vacuum: 3 x
• Sterilization temperature: 134°C
• Sterilization time: 5 minutes
• Drying time: at least 10 minutes

Clearance of the device
The reprocessing of the medical device ends with the documented clearance for storage and renewed use.

• Document the clearance of the medical product after reprocessing.

Storage

• Storage times shall depend on the type of packaging used and the storage environment.
• Packaging must be protected against dust, humidity, excessive temperature fluctuations, damages and all contamination risks.
• Potential external contamination of the sterile barrier system should be taken into account in terms of aseptic preparation when establishing the storage conditions.

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