PVA Nasal Dressing 80x20x15 mm

SIDA-CEL nasal hemostatic sponges are mainly comprised of PVA expansive sponge, in various sizes, with or without hemostatic gauze cover, string and airway tube.

PRODUCT PROPERTIES
When in contact with water, the gauze cover can form a viscous gel and block the bleeding capillary vessel quickly. In the meantime, the expanded sponge provides a controlled pressure on bleeding site. This double function makes the hemostasis easily accomplished.

INDICATIONS
Epistaxis and post-operative hemostasis of nasal cavity and paranasal sinus.

CONTRAINDICATIONS
Those who are allergic to the product are prohibited.

PRECAUTIONS
Package should be checked before use. Product must not be used if its package has been damaged.

After the product is opened, keep it dry. Before use, product should not be moistened with water or water-bearing liquid.
When the product is used, keep gloves and apparatuses dry.
When the product is used for ENT department, the string must be fixed to the wing of the nose or the cheek, to prevent being aspirating into the respiratory tract.
Product should not be kept in the wound for more than 72 hours.
Product can’t be re-used.
ADVERSE EFFECTS
In rare instances, the physiochemical conditions associated with nasal surgery, both with and without nasal packings, may prevent a risk of toxic shock syndrome (TSS). Warning signs of TSS include sudden fever, vomiting, diarrhea, dizziness, fainting (or near fainting when standing up), and/or a rash like a sunburn.
Nasal dressings exhibit no antimicrobial properties; they are not bacteriostatic towards pre-existing infections, nor do they recommended that appropriate treatment be instituted.

Rarely, displacement and ingestion of nasal dressing may occur.
Expansive sponge is non-toxic and is considered safe to pass in the alimentary tract. The patient should be monitored in the normal manner as an ingestion of any non-toxic material. If aspiration should occur, prompt medical intervention is imperative, with close patient monitoring and airway support pending the removal of the material.
DOSAGE AND ADMINISTRATION
1. Select a proper type of Nasal Dressing and unpack the product, then take it out.
2. Insert the Nasal Dressing into the part required along the nasal meatus.
3. Inject a proper amount of sterilized water, saline or antibiotic solution into the gel expansive sponge with an injector, to make the sponge expand fully.
4. Fix the string to the wing of the nose.
5. After 24 to 48 hours, observe whether there is active hemorrhage. If not, inject sterilized water or physiological saline into nasal cavity to saturate the sponge. Ten minutes later, gently pull the string and take the product out.
STORAGE
Make sure to store in a shady, well-ventilated and clean room,
without corrosive gas. The preferred storage temperature should
be between 5 - 45 oC.

Nassal Dresing Raw-Material Specifications: Water soluble synthetic polymer

• Specially designed to stop nasal bleeding immediately and efficiently
• Minimizing edema. 
• Comfortable for patients.
• Lint Free.
• High absorption PVA material.
• Swell and Seal technology, activated within seconds after coming in touch with blood or other fluids inside the nose cavity.

PVA as a material is:

• White, odorless material
• With pH 6~8
• Non toxic

PRODUCT SPECIFICATIONS

Type: Sterile
Material: PVA
Size (cm): Major sizes: 80x20x15cm and 100x20x15cm
Available in many others, upon request.
Features: Available in various sizes, with or without hemostatic gauze cover, string and airway tube
Ref. No.: 181XX (please advise label for the specifications)
Intended Use: Epistaxis and post-operative hemostasis of nasal cavity and paranasal sinus.
Certification: CE 0653
Classification: Class Ιs, according to Annex IX of Council Directive 93/42/EEC
Sterilization Method: Irradiation
Conformity: MEDDEV 2.4/1 Rev. 9 - June 2010 Rule 5
Applicable Standards: ISO 9001, ISO 13485, ISO 14971, ISO 11607, ISO 10993, ISO 13726, ISO 15223, ISO 14079, ISO 11137
Storage Conditions: Dry and ventilated place, with no active gases, under 5-45oC
Shelf Life: 3-year
Primary Packing: Individually packed in foil bags as per different dimensions
Secondary Packing: Box of 5/10/15 packs as per different dimensions
Precaution: Gloves and surgical instruments should be kept dry before use.