English / Turkish

The Name or Trade Name of The Medical Device

HYDROGEL Wound Dressing
HYDROGEL Wound Dressing is a sterile single use device available in various sizes.

HYDROGEL Wound Dressing 10x10 cm
HYDROGEL Wound Dressing 10x20 cm
HYDROGEL Wound Dressing 6x11 cm
HYDROGEL Wound Dressing 6x6 cm
HYDROGEL Wound Dressing 7,5cm ∅
HYDROGEL Wound Dressing Upper Face
HYDROGEL Wound Dressing Lower Face
HYDROGEL Wound Dressing Neck
HYDROGEL Wound Dressing Lower Head

The Name and The Address of The Manufacturer

T-Biyoteknoloji Laboratuvar Estetik Medikal Kozmetik San. Tic. Ltd. Şti.
Tahtalı Mah. Değirmen Yolu (460) Sk. No:10 Nilüfer / Bursa /Turkey
Phone: +90 224 246 8522
E-mail: info@tlab.com.tr

Intended Use of the Product

HYRDOGEL Wound Dressing is used for 1st and 2nd degree burns, bed sores, decubitus ulcer wounds, incision wounds, sun burns, all sports injuries where the epidermis is damaged, and superficial wounds where the epidermis and dermis are damaged.

Device Description

HYDROGEL Wound Dressing is a three-dimensional network of cross-linked hydrophilic polymers that are insoluble in water and interact with aqueous solutions by swelling. HYDROGEL Wound Dressing is formulated to provide moisture to a dry wound, maintain a moist wound environment that enhances wound healing and helps prevent wound desiccation, and promotes autolytic debridement of a dry wound by providing moisture to devitalized tissue.

HYROGEL Wound Dressing;

  • Air permeable, but it does not allow bacteria to pass through, thus minimizing the risk of infection.
  • Absorbs exudate fluid, removes wound discharge, clots and dead tissues.
  • Does not stick to the wound, HYRDOGEL Wound Dressing replacement is painless and without traumatizing the wound.
  • Fully transparent, it is possible to observe healing without removing the wound.
  • Prevents the formation of excessively large scars, provides smooth skin formation.
  • Not toxic or allergic.

Indication for Use

HYRDOGEL Wound Dressing is used in the treatment of

  • Burn wounds
  • Trophic ulcer wounds
  • Bed wounds
  • All skin injuries where moisture is suitable
  • Radiation burns.

Contraindications

HYDROGEL Wound Dressings are contraindicated for use on wounds with heavy exudate.

Possible Adverse Events

Rarely, with wound dressing use, irritation (redness), or maceration (whitening) of the surrounding skin, or hyper granulation (excessive tissue formation in the wound) may develop.

Wound Dressing Application

  1. Cleanse wound and surrounding skin according to facility policy.
    Note: Follow facility guidelines for infection control.
  2. Grasp package tabs and pull apart. Remove the dressing from the release plastic wrap. Either side may be placed on the wound.
  3. Dressing should overlap the wound by 1cm.
  4. Transparent film, island dressings, roll gauze, tapes, gauze and ABD pads can be used as secondary dressings.

Removing the Dressing

  1. Change the dressing as needed. Hydrogel Wound Filler may be left in place for up to 24 hours. Frequency of changing will depend on factors such as the type of wound and volume of drainage.
  2. Carefully remove the secondary dressing and dispose of according to local procedures and guidelines.
  3. Cleanse or gently flush the wound with sterile saline or wound cleanser to remove necrotic debris.
  4. At the time of dressing change, if the dressing is adhered to the wound surface, saturate with wound cleanser or sterile normal saline, allow the dressing to soften, and gently remove.
  5. Avoid forceful removal of the dressing to minimize disruption of the wound.

Storage, Shelf Life and Handling Information

  • HYDROGEL Wound Dressing is a sterile device; do not use the device if the package is opened or damaged.
  • Store at temperatures <30º C.
  • Store in a cool, dry place.
  • Do not expose to direct sunlight.
  • For shelf life, refer to the expiration date printed on labelling.

Precautions, Warnings, Measures to be Taken and Limitations

  • For external use only.
  • Treatment of any wound should be part of a well-defined plan and under the supervision of a health care professional.
  • Bleeding should be controlled before application of wound fillers or cover dressings.
  • Observe the wound for signs of infection. Consult a health care professional if any of the following are noted: fever, increased pain, redness, bleeding, swelling, unusual odor, increased drainage or cloudy or foul drainage.
  • If the wound does not begin to show signs of healing or if any other unexpected symptoms occur, consult a health care professional.
  • Single use only, once opened this product should not be reused due to risk of contamination and infection.

Symbols and Explanations (Product Label & IFU)

European Medical Devices Directive 93/42/EEC of 14 June 1993
Notified Body: Notice (2195)

Indicates manufacturer declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation.

Manufacturer

Indicates the medical device manufacturer, as defined in EU Directive 93/42/EEC.

Catalogue Number

Indicates the manufacturer's catalog number so that the medical device can be identified NOTE: Synonyms for "catalogue number" are "reference number" and "reorder number"

Batch Code

Indicates the manufacturer's batch code so that the batch or lot can be identified

Use by date

Indicates the date after which the medical device is not to be used.

Sterile R
Sterilized Using Irradiation

Indicates a medical device that has been sterilized using irradiation.

Do Not Re-sterilize

Indicates a medical device that is not to be re-sterilized.

Do Not Use if Package is Damaged
Indicates a medical device that should not be used if the package has been damaged or opened.
Keep Away from Sunlight
Indicates a medical device that needs protection from light sources.
Keep Dry

Indicates a medical device that needs to be protected from moisture.

Temperature Limit

Indicates the temperature limits to which the medical device can be safely exposed.

Do Not Reuse

Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.

Consult Instructions for Use

Indicates the need for the user to consult the instructions for use.

Electronic Instruction Manual

Indicates on product packaging that relevant information for use of the product is available in electronic form in addition to, printed paper form.

Dikkat
Caution

Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.

IFU-AG4000.R01  |   Release Date: 25/12/2020   |   Revision Date: 22/04/2020