INSTRUCTIONS FOR USE Disposable saliva ejector
1. IDENTIFICATION OF THE MEDICAL DEVICE AND OF THE COMPANY
Company identification :
WORLD - WORK srl Via del Progresso, 47 36054 Montebello Vicentino (VI) tel. 0444/574297
fax 0444/370543
e-mail: info@worldwork.it
Product name :
Disposable saliva ejector World Work
Product description :
Disposable saliva aspirator consisting of: 1) a transparent PVC tube or in various transparent and non-transparent colors, with iron framework galvanized or copper-plated (wire inserted on the wall of the cannula); 2) perforated cap, in neutral transparent PVC or POLYETHYLENT (LDPE) or in various colors- transparent and non-transparent caps can be welded to the tube or removable. The “aesthetic” variants of the product are identical in its components and operation: these consist exclusively of the different color combinations of the cannula and / or cap, whether it is welded or not welded, by the wire (galvanized or copper-plated) and finally, the length of the cannula and the quantity of pieces per package (bag) and carton (packaging). The cannula is also produced in a mint and strawberry flavor variant.
Technical specifications:
Cannula: Length: 130mm ± 10 (short model) or 150mm ± 10 (long model) External diameter: 6.50 mm ± 10 Appearance: smooth surface
Filter part: Length: 14.25 mm ± 0.10 (vers. In LDPE) 14.50 mm ± 0.10 (vers. In PVC) External diameter: 9.00 mm ± 0.10 Shape: filter with n. 6 openings of about 1 mm
2. INSTRUCTION FOR USE
Intended use:
Disposable cannula for saliva aspiration
Directions for use:
The medical device contained in the package must be used exclusively to aspirate the saliva of patients receiving dental treatment Do not use the medical device for uses other than the indications for use, such as direct aspiration on the surgical site. The individual materials that make up the cannulae can cause individual intolerance and related allergic reactions and / or irritation. Contact the manufacturer immediately in the event of an accident or near-miss.
Warnings :
Recipient patients:
People of any age, gender and physical characteristics
Users:
Dentist and dental assistant
Clinical benefits:
Promotes dental performance and reduces patient discomfort
Performance characteristics:
Maintenance of the shape modeled by the user Stable fixation of the cap to the cannula
Guaranteed passage of saliva even in conditions of bent cannula No leakage of the wire from the cannula in all conditions of use.
Use of the product:
The device must be checked before each use in order to detect anomalies and/or damage during transport and/or storage: 1. do not use if the package is not intact 2. take the cannula and check: • general functionality of the device • adequate degree of cleanliness of the device • absence of cuts, holes, lacerations or abrasions • integrity in general 3. make sure, exerting a slight traction, that the tipis firmly anchored to the cannula SIf the above conditions are met, the device can be considered ready for use; otherwise it is necessary to remove the device from service immediately and contact the manufacturer. Usage: 1. Press the cannula to the terminal of the suction circuit of the pneumatic or hydraulic saliva
suction system and check that it is correctly connected 2. Shape the cannula to fit the patient’s oral cavity.
Prduct storage:
The device must be stored in a dry, well-ventilated place, protected from light and sun. It must not come into contact with heat sources and flammable agents and/or substances, chemical agents, which could alter its safety characteristics. Protect from frost and humidity.
• Temperature of use: from 5 to +40 ° C • Storage temperature: from 5 to +40 ° C • Relative humidity: 0 to 100% • Store the material raised off the ground.
When opening the carton: • Remove the packaging and arrange the material in a visible way. • Check that all the parts included in the accompanying document are present. Once the carton has been opened, the individual bags must be stored away from light and heat sources. After opening, the package must be closed in order to avoid any contamination of the product. The device is supplied NON-STERILE and is single use, reuse is prohibited. Damage to the device caused during transport and handling is not covered by the warranty. Repairs or replacements of damaged parts are the responsibility of the customer.
Disposal of the product:
At the end of use, the cannula has to be removed and disposed of in accordance with the provisions in force in the user’s country.
Pay attention to the handling and disposal of the medical device, using adequate personal protective equipment to avoid possible infections or microbial risks.
Risk of reuse:
Severe / permanent injury or severe worsening of the patient’s condition.
Contraindications:
Due to the particularity of these devices, there are no known contraindications and side effects.
3. PRODUCT PACKAGING AND LABELING The product is packed in non-sterile bags of 100 or 250 pieces. Each package is equipped with specific labeling. 4. INFORMATION ABOUT CONNECTING WITH OTHER DEVICES The device must be connected to the common saliva suction system used in the medical-dental environment. There are no accessories or connection to other devices. 5. LIMITS OF LIABILITY The construction of the product is particularly aimed at ensuring a high degree of operational safety, within the limits set by these instructions for use. The manufacturer assumes no liability in the event of use of the product in the conditions hereinafter considered as improper use:
• Anything not specifically covered by the instructions • Failure to comply with the manufacturer’s prescriptions • Total or partial non-compliance with the instructions • Inappropriate storage • Use for purposes other than that set for the device
6. REPORTING OF SERIOUS ACCIDENTS Report any serious incident in relation to the device to the manufacturer and the competent authority of the Member State where the user and / or patient is established.
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