[Intended use]:

The Sterile Hydrocolloid Dressing is used to treat low exudating wounds. It is suitable for debridement of trauma and postoperative wound care.

[Intended users of the device]:

Laypersons.

[Intended patient population]:

Adults and children.

[Indication]:

The Sterile Hydrocolloid Dressing is used to treat low exudating wounds. It is suitable for debridement of trauma and postoperative wound care.

[Contraindications]:

Hydrocolloid dressing should not be used on infected wounds nor on third degree burns. It should not be used on highly exudating wounds.

[Clinical benefits]:

Ø  Creates a moist environment, suitable for treating chronic wounds, promoting wound healing, while slight cooling effect aids patients comfort.

Ø  Waterproof.

Ø  Soft protect for wound.

Ø  Leaves no residue on wound upon removal of the dressing.

[Side effects]:

The product have no known side effects.

[Sterilization]: Radiation

[Shelf life]: 3 years.

To apply the wound dressing: 

1.Keep the skin surrounding the wound clean and dry for secure application.

2.Select a dressing of certain specification according to the wound area. The dressing should be larger than 5-10mm than the wound in margins.

4. Open the outer package and pick out the product, strip the release paper off PU film, place the PU film on the wound directly.

To remove the wound dressing:    

1. Carefully remove the Hydrocolloid Wound Dressing by lifting one edge and gently peeling the dressing from the wound site.

 2. Properly dispose of the dressing.

Warning: Do not reapply after removal

3. Prior to re-dressing, cleanse the wound as directed by a health care professional.

4. Repeat the application procedure outlined above as needed.

[Use warnings]:

Ø  Can not use it when the package is damaged;

Ø  For single use;

Ø  Destroy it after using;

Ø  Using it immediately after opening the primary package.

[Storage and transportation]:

1, Store at room temperature, protected from moisture, light, and dust.

2, The device shall be taken care during transportation and handling.

[Contact information]:

Name: Zhejiang Wellong Medical Technology Co., Ltd.

Address: Lvshan Industrial area, Changxing County, 313105 Huzhou, Zhejiang Province, China

Website: www.wellongmedical.com

The authorized representative of European Union:

Name: Shanghai International Holding Corp. GmbH (Europe)

Address: Eiffestrasse 80, 20537 Hamburg, Germany

Tel: +49-40-2513175

Fax: +49-40-255726

E-mail: shholding@hotmail.com

Contactor: JIN LIANG

Single Registration Number (SRN): DE-AR-000000001