Components It is made of inner PVA sponge
Indications Hemostasia of nose bleeding, Hemostasia after nasal operation( turbinectomy, nasal septum surgery, nasal polypectomy).
Applications
1. Choose suitable size and take out the product; 2. Insert the nasal dressing into the nasal cavity; 3. Infuse distilled water with injector till the nasal dressing expands suitably; 4. Fix the pulling string; 5. Observe the wound after 24~48 hours. If there is no active bleeding, soften the nasal dressing with some sterile water. Take out the nasal dressing till it is softened.
Contraindications
1. Allergic people are not allowed to use. 2. It is disposable product, please use after opening. 3. No reuse. 4. Do not use if the packing is torn...
Storage Please store it in dry, clean and ventilated place without caustic gas in room temperature.
Shelf Life: 2 years
Indications
Hemostasia of nose bleeding, Hemostasia after nasal operation( turbinectomy, nasal septum surgery, nasal polypectomy).
Quality control
We have established the Quality System and SOP according to ISO 13485 and Medical Device Directive 93/42/EEC. The quality control points during in production process were established to ensure the non-confirming products not to enter into next process or out of factory. On the other hand, the internal audits are implemented and submit some deviation then correction and protection action.
No. | Test subject | Standard items | Requirements | Results | |
1 | 2 | ||||
1 |
Components and materials |
4.2.1 | Composed of PVA sponge (dry compression molding) and traction string (Non-absorbent thread). | complied | complied |
2 | 4.2.2 |
Made of foam of polymer materials |
complied | complied | |
3 | 4.3 | Size:80mm×20mm×15mm | 79.5×19.5×14.7 | 79.6×19.5×14.6 | |
5 | Traction String Length>40mm | 160 | 159 | ||
6 | 4.4 |
Surface clean, color uniform, free of impurities, burrs, damage and other defects |
complied | complied | |
7
|
4.5 |
Traction string be firmly attached,not be torn off in normal use, be able to withstand at least the pull of 5N |
complied | complied |
Sizes |
|
KHB-452016 |
Small, with airway and strings |
KHB-602016 |
Middle, with airway and strings |
KHB-802016 |
Large, with airway and strings |
KHB-1002016 |
Extra Large, with airway and strings |