Product description

Hartmann Omnistrip Wound Closure Plasters 12x101 mm

Hartmann Omnistrip is a sterile adhesive tape that replaces surgical sutures for closing small wounds and surgical incisions. It is intended for use by medical personnel and laypeople.

Composition

Omnistrip is made of flesh-colored non-woven fabric coated with self-adhesive polyamide material.

Intended use

Omnistrip suture replacement adhesives are intended for the primary closure of small wounds healing by primary adhesion (cuts and lacerations), surgical incisions and for supporting the healing and stabilization of surgically sutured wounds.
The product can be used on humans on damaged and undamaged skin by medical personnel and people without medical training.

Contraindications

Omnistrip is not intended for the closure of wounds that are healing through granulation. It is also not intended for infected, difficult-to-heal, or bleeding wounds.

Special precautions

In the absence of available data indicating any harmful effects and due to the partially limited experience with the use of this product in sensitive populations such as infants, children, pregnant or breastfeeding women, the product should be used with caution, as directed by a physician.

Side effects

Adverse reactions may occur in patients with an allergy or hypersensitivity to any of the component materials.
How to use (see pictograms 1-4 in the leaflet)
Before applying, make sure your skin is dry and clean.
1. Remove the protective paper from the center of the adhesive replacing the surgical thread.
2. Hold the edges of the Omnistrip with the outer protective paper, place it on the wound perpendicular to the incision, and press firmly. During this procedure, ensure that the suture adhesives are not under tension.
3. Remove the outer protective papers one by one.
4. Re-apply the adhesive tapes replacing the surgical threads.
When removing Omnistrip, ensure each end is pulled towards the center of the wound and then gently lifted.
It is recommended to carefully remove adhesives replacing surgical threads, especially in the case of older or sensitive skin.

Special instructions

The adhesives can be applied individually. Applying the adhesives crosswise is recommended for joints and areas of the body where the edges of the incision are exposed to stress and stretching. The device can be left in place for up to 7 days, depending on clinical evaluation. It can be immediately replaced with a new one up to three times.
Reusing a single-use medical device is dangerous. Reprocessing devices for reuse can seriously compromise their integrity and affect their performance. Information is available upon request. Before opening the package, carefully inspect it for damage. Do not use the product if the package shows visible signs of damage, such as cracks, grooves, punctures, or an uneven, torn, or incomplete seal.

Product disposal

To minimize the risk of potential infection or environmental contamination, Omnistrip disposable components should be disposed of in accordance with procedures established by applicable local laws, regulations, and infection control standards. The product should be disposed of with hospital waste.

Incident reporting

For patients/users/third parties in the European Union or in countries with the same regulatory system (Regulation (EU) 2017/745 on medical devices): If a serious incident occurs during or as a result of the use of this device, please report it to the manufacturer and/or its authorised representative and to the relevant national authorities.

Responsible entity:

PAUL HARTMANN Polska Sp. z o. o.

CE 0123

This is a medical device. Use it according to the instructions for use or label.

Important information about the medical device:

• Medical device - has the CE marking.
• It has an EU declaration of conformity
• Includes user manual in Polish
• Includes label in Polish

Storage and transport of medical devices are in accordance with the conditions specified by the manufacturer.

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