Product features:

UrgoK1 Compression System 10 cm, ankle circumference 18 - 25 cm, 1 piece

Characteristics:
UrgoK1, for all patients with venous lower leg ulcers or lower leg edema, offers a new standard in compression therapy. Thanks to innovative 3D weaving technology, the multi-patented UrgoK1 combines the properties of a short-stretch and a long-stretch bandage in a single compression bandage, thus achieving 24-hour effectiveness with maximum wearing comfort. UrgoK1 is a multi-component compression system in a bandage made of polyamide, elastane, and polyester yarns, which are bonded together using 3D weaving technology. The exclusive PresSure system technology, based on pressure indicators, makes it easy to apply the bandage with the correct stretch and overlap according to the chosen size of the UrgoK1 system. The included fastening system allows the bandage to be secured in place after application.

This product is a medical device. Please read the instructions in the package leaflet carefully and familiarize yourself thoroughly with the functions and use of the product before use.

Indications:

• Treatment of venous lower leg ulcers and/or edema of the lower extremities in adults when strong compression pressure is recommended.

Contraindications:

• Moderate or severe arterial disease, especially with a current ankle-brachial pressure index (ABI) < 0.8.
• Patients with phlegmatia coerulea dolens or septic phlebitis.
• Edema in congestive heart failure.
• Epifascial arterial bypass.
• Known hypersensitivity to any of the ingredients.

The advantages of UrgoK1 at a glance:
Continuous compression:

• Special material treatment prevents slipping.
• Effective at rest and in motion, providing the therapeutically necessary pressure.
• Wear time of up to 7 days with repositionable fastening system for wound assessment.

Effectiveness:

• Fast, easy and safe application.
• Just one bandage and a simple wrapping technique.
• Quick setup in under 2 minutes.
• Reliable and safe printer reach thanks to print indicators.

High wearing comfort:

• Only a thin, discreet, breathable bandage, thus offering more options, for example, when choosing shoes.
• Greater freedom of movement improves the quality of life.
• Improves patient comfort and contributes to patient adherence.

Precautions:

• This medical device must only be used by persons trained in the application of compression bandages. Read the instructions for use carefully.
• Single-use medical device.
• Do not sterilize.
• Do not use in direct contact with a wound.
• In the case of arterial bypass surgery, heart failure, peripheral neuropathy (for example, in the case of diabetes), infected dermatitis in the ulcer environment, or acute cellulitis (erysipelas), the compression system may only be used after referral to a specialist and under close medical supervision.
• In cases of an ABI = 1.3%%, where there is suspicion of medial sclerosis or a history of revascularization, a comprehensive vascular assessment is recommended before starting compression therapy.
• In the case of an infected lower leg ulcer, the infection should be treated in combination with compression therapy.
• Follow the application instructions to achieve the recommended therapeutic pressure. The PresSure system was specifically designed to facilitate the application of the bandages.
• If additional material is used to fix the bandages beyond the supplied fastening system, this must be done with care to avoid a reaction to this foreign material.
• This compression system should be worn continuously day and night, as directed by a doctor, until the next appointment.
• If discomfort, pain or skin reactions occur when using the product, the patient should consult their doctor.
• Any serious incident related to the product must be reported to the manufacturer and the relevant national authority.

Reporting of side effects:
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, Germany, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

Distribution in Germany:
Urgo Medical GmbH
Justus-von-Liebig-Straße 16
66280 Sulzbach
Germany

This patient information leaflet was last revised in October 2022.

Source: www.urgo.de
As of August 2023