DSI DENTAL Absorbable Hemostatic Compressed Sponge Instruction Manual

DSI DENTAL Absorbable Hemostatic Compressed Sponge

Product Information

Specifications

• Product Name: Absorbable Hemostatic Compressed Sponge
• Model: DSI Sponge HD
• Composition: Each DSI Sponge HD 10×20 plug contains 90mg of hydrolyzed collagen
• Intended Use: Used as haemostatic agents after tooth extractions and oral surgery

Product Usage Instructions

Application Form
The sterile absorbable DSI Sponge HD plugs are used as haemostatic agents after tooth extractions and oral surgery. The application of DSI Sponge HD into the defect cavity supports the stabilization of the produced blood clot whilst helping to control bleeding at the application site.

Mode of Application

1. Remove DSI Sponge HD from sterile packaging.
2. Cut the sponge to the desired shape and size with sterile instruments.
3. Use the sponge in a dry state with light pressure for better adhesion and haemostasis.
4. Insert the DSI Sponge HD into the extraction socket or cavity as required.
5. Suture over or hold in place with fibrin glue if needed.
6. Use dry instruments and gloves due to collagen’s affinity with blood-covered surfaces.

Post-Operative Care
Do not rinse your mouth out on the day of surgery. Follow all post-operative care instructions provided by your healthcare provider.

FAQ

Can DSI Sponge HD be reused?

No, DSI Sponge HD is intended for single use only. Reusing the product can pose a risk of infection for the patient and user.

What are the contraindications for using DSI Sponge HD?

Do not use DSI Sponge HD in patients with a known hypersensitivity to collagen products, in infected areas, or during pregnancy and lactation.

Are there any side effects associated with DSI Sponge HD?

While the risk is low, there is a possibility of intolerance reactions despite the confirmed low antigenicity of the product.

APPLICATION FORM

The sterile absorbable DSI Sponge HD plugs are used as haemostatic agents after tooth extractions and oral surgery. The application of DSI Sponge HD into the defect cavity supports the stabilization of the produced blood clot whilst helping to control bleeding at the application site.

COMPOSITION
1 DSI Sponge HD 10×20 plug contains 90mg of hydrolyzed collagen.

INTENDED USE

The DSI Sponge HD plugs are used as haemostatic agents after tooth extractions and oral surgery. DSI Sponge HD can be combined with DSI Repio Glue in patients with an increased risk of bleeding.

MODE OF APPLICATION

• After removal from the sterile packaging DSI Sponge HD can be cut to the desired shape and size with sterile instruments. Please read instructions carefully prior to use.
• The DSI Sponge HD plugs are used in a dry state with light pressure to achieve better adhesion and haemostasis.
• The DSI Sponge HD is inserted into the extraction socket or the cavity as required.
• Once inserted into the desired cavity DSI Sponge HD can be sutured over and/or held in place with fibrin glue as required.
• Due to the affinity of collagen with blood-covered surfaces, dry instruments and gloves should be used when administering the DSI Sponge HD.
• Due to the absorbability of the DSI Sponge HD plugs, they do not have to be removed. Plugs will be absorbed within 3 – 4 weeks;
• Absorption time may differ as it is dependent upon multiple patient-specific factors including but not limited to the site of implantation, comorbidities and blood perfusion.
• DSI Sponge HD may only be used by qualified medical professionals.

Medical treatment of severe bleeding disorders is mandatory prior to the beginning of the procedure. Unless otherwise prescribed, the DSI Sponge HD can be applied directly into the extraction alveolar. The DSI Sponge HD plugs mould themselves into the site of extraction or excision wound respectively, stop bleeding and will be absorbed.

CONTRAINDICATIONS

• The DSI Sponge HD must not be used in patients with a known hypersensitivity to collagen products
• The DSI Sponge HD must not be used in infected areas.
• The DSI Sponge HD must not be used during pregnancy and lactation.

WARNINGS

• Chlorine-releasing antiseptic agents, tannins and caustics should not be used in combination with collagen.
• DSI Sponge HD plugs are not intended to be sutured through; doing so may compromise the performance of the DSI Sponge HD.

SIDE EFFECTS
There is a possible risk of intolerance reactions, despite the confirmed low antigenicity.

FURTHER NOTES

• Due to the affinity of collagen to bleeding surfaces, dry instruments and gloves have to be used when applying DSI Sponge HD.
• The product is intended for single use only.
• DSI Sponge HD must not be reused, there is a risk of infection for the patient and/or user and the functionality of the product cannot be guaranteed.
• Remaining material, left over due to cutting for example, must be disposed of according to local procedures and guidelines.

NOTES FOR POST-OPERATIVE CARE FOLLOWING DENTAL SURGERY

• Actions to be avoided:
• Do not rinse your mouth out on the day of surgery (may dislodge clot).
• Do not drink alcohol or hot drinks on the day of surgery (may increase blood pressure or induce hyperaemia).
• Do not smoke for at least 24 hours (causes vasoconstriction).
• Carry out physical activity on the day of surgery (increasing blood pressure). Recommended:
• Sip lukewarm drinks carefully (helps avoid clot removal by washing out the socket).
• Bite on gauze or clean, damp handkerchief for 10 minutes if the area bleeds, preferably sitting upright in a chair.
• Rinse mouth gently with hot salt mouthwash or Chlorhexidine (0.2%) mouthwash after 24 hours. Continue regular mouthwash use over the following week, especially after meals.
• Clean teeth as normal, avoiding the area of surgery for 24 hours.

STERILITY
DSI Sponge HD may not be re-sterilized and opened single packs must be discarded. Do not re-use DSI Sponge HD in whole or in part, as it may compromise sterility and/or the performance of the product.

STORAGE

• Store between 0-25°C.
• Store protected from moisture and direct sunlight.
• Do not refrigerate.
• Store out of the sight and reach of children.

PRODUCT CONFORMS TO THE ESSENTIAL REQUIREMENTS OF THE COUNCIL DIRECTIVE 93/42/EEC CONCERNING MEDICAL DEVICES.

SYMBOLS

Visit www.dsisrael.com or email to [email protected] for more information.

References

• DSI Dental Solutions -> Leading Dental Supplier in Israel

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