Disposable Intranasal Atomization Device

Disposable Intranasal Atomization Device is a special drug delivery device, which consists of a needle, a dose limiter, an atomizing device, and a syringe. It can atomize liquid drugs into particles of different sizes and absorb them through the nasal mucosa Acting on specific parts or the whole body, it has the advantages of being painless and avoiding the first-pass effect, and is suitable for the delivery of various types of drugs such as vaccines and peptides.

Application

Disposable Intranasal Atomization Device is used for aerosolizing liquid drugs, and is suitable for clinical aerosol administration in the nasal cavity.

Advantage

1. Painless administration: Umbrella-shaped spray avoids local pain or inflammation caused by injection, and is more easily accepted by patients.

2. Rapid absorption: micron-sized, evenly distributed drug droplets can be sprayed out through the atomization device, and the absorption effect is good.

3. Self-destruction device: push the push rod to the bottom to achieve the purpose of self-destruction of the device, ensuring the safety of one-time use.

4. Precise drug administration: the dose limiter can realize a single quantitative drug administration (the control dose is 0.1ml±0.005ml).

Product Performance

1. Appearance: The product should be clean, free of particles and foreign matter, and should not have burrs, burrs, plastic flow, or defects; the syringe jacket should be transparent enough to clearly see the reference line, and there should be no obvious lubricant accumulation on the inner surface ;The plastic needle should be clean, the needle tube should be straight, and the needle point should be free of defects such as burrs and hooks.

2. Scale: The scale and numbers meet the specified requirements, and the printing should be complete, with clear handwriting, clear lines, and uniform thickness.

3. The distance between the hands of the syringe should not be less than 8mm; the fit between the piston and the jacket should be good.

4. The patency of the Luer needle should be good, and the particle pollution index should not exceed 90.

5. Body tightness: There should be no liquid leakage or gas leakage at the piston, and the piston and push rod should not be separated.

6. Capacity tolerance: the maximum tolerance equal to or greater than 1/2 of the nominal capacity shall be ±5% of the discharge volume.

7. Residual volume: The volume of liquid remaining in the Luer tube should not exceed 0.1mL, and the residual volume of the entire product should be less than 0.2mL.

8. Fog particle equivalent volume particle size distribution: DV10: 12±4µm, DV50: 29±6µm, DV90: 50±10µm.

9. The controlled dose of the dose limiter should be 0.1mL±0.005mL.

10. The residual amount of ethylene oxide should not exceed 10μg/g.

11. The product is sterilized by ethylene oxide and should be sterile, and the bacterial endotoxin limit should be less than 0.5EU/mL.

Contraindications

1. Those who are allergic to product materials (polypropylene plastic/PP+polycarbonate/PC+isoprene rubber) are prohibited.

2. It is forbidden for those who are not suitable for nasal administration.

Precautions, Warnings, and Tips

1. This product should be purchased and used under the guidance of a doctor.

2. This product can only be used by the same person, and cannot be used by multiple people at the same time.

3. The nasal spray device of this product is designed for self-destruction and is limited to one-time use. Secondary sterilization is strictly prohibited.

4. This product should be operated by professional medical personnel.

5. This product is provided aseptically. If the package is damaged, there are foreign objects inside, or the protective cover falls off or is polluted, it is forbidden to use it.

6. It is forbidden to use this product beyond the expiration date.

7. Please read the instruction manual carefully before use.

8. This product is strictly prohibited for human injection.

9. When operating the product, it is forbidden to touch the liquid medicine or needle with hands or unsterilized items.

Installation and Usage Instructions

1. Open the package, take out the syringe and plastic needle, install the plastic needle on the top of the syringe, and tighten it.

2. Open the medicine used together, take off the plastic needle cover, and draw out about 0.2ml of medicine.

3. Put on the needle shield, unscrew the plastic needle and discard it.

4. Remove the nasal spray device and screw it onto the top of the syringe.

5. Install the dose limiter according to the usage requirements. Pinch the end clip of the dose stopper so that the notch of the clip is up.

6. Flick the syringe lightly to expel air bubbles, push the syringe plunger, and use the edge of the dose limit clip to press against the syringe jacket. When the exhaust action is completed, the dose is automatically calibrated to 0.2mL.

7. Rotate the dose limit clip 90°, perpendicular to the bead of the syringe. Tilt the patient's head back slightly, put the nasal spray head against one nostril and quickly push the push rod to complete the nasal administration on one side.

8. Remove the dose limiting clip, put the nasal spray head against the other nostril, and push the push rod to the bottom quickly and firmly to complete all the doses. During the second administration, it is normal for the syringe plunger to be slightly stuck.

Product maintenance and maintenance methods, special storage, transportation conditions, methods

After packaging, the product should be stored in a ventilated, dry and clean warehouse with dust-proof measures. When storing, keep away from heat sources and avoid direct sunlight. Transport with general means of transportation, and handle with care during transportation and loading and unloading. The means of transportation should be kept clean and dry, and the product should be strictly prevented from being damp, polluted and damaged. Do not mix with toxic, corrosive or flammable materials during transportation.

Product Certificate

Medical Device Certificate