Product features:

UrgoK2 Lite Compression System 10 cm, ankle circumference 25 - 32 cm, 6 pieces

Characteristics:
UrgoK2 Lite (or UrgoK2 Lite Latex Free) is a two-component compression system for providing moderate pressure, consisting of a short-stretch and a long-stretch bandage. The exclusive PresSure system technology, based on pressure indicators, facilitates application with correct stretch and overlap according to the selected set.

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.

The advantages of UrgoK2 Lite and UrgoK2 Lite Latex Free at a glance:

• Comfortable to wear during the day and at night for improved patient adherence.
• Easy wearing of shoes.
• Improved ankle mobility.
• Easy, quick and precise application thanks to the PresSure system: Therapeutic pressure is achieved from the very first application.
• Reduced compression pressure at the ankle (approx. 20 mmHg).
• The compression system can be worn for up to seven days.

Indications:

• Treatment of venous or mixed arteriovenous lower leg ulcers, as well as venous edema and lymphedema in adults requiring moderate compression.

Contraindications:

• Severe arterial disease, especially with a current ankle-brachial pressure index (ABI) < 0.6.
• Patients with phlegmatia coerulea dolens or septic phlebitis.
• Edema in congestive heart failure.
• Epifascial arterial bypass.
• Known hypersensitivity to one of the ingredients—especially latex—for URGO K2 Lite.

Precautions:

• This medical device must be applied by a person trained in the application of compression bandages. Read the instructions for use carefully.
• For single use only: Do not wash, as this may impair the performance of the medical device.
• Do not sterilize.
• Do not use in direct contact with a wound.
• In the case of an arterial bypass, heart failure, peripheral neuropathy (for example in the case of diabetes), infected dermatitis in the ulcer area 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 of 1.3, suspected 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.
• The effectiveness of URGO K2 Lite (or URGO K2 Lite Latex Free) has been tested and validated for the combined use of KTech Lite and KPress (or KPress Latex Free).
• Follow the application instructions to achieve the recommended therapeutic pressure. The PresSure system was specifically designed to assist with bandage application.
• This compression system should be worn continuously day and night until the next appointment, at the discretion of the healthcare provider.
• If discomfort, pain or skin reactions occur while wearing the product, the patient should seek medical advice.
• 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 leaflet was last revised in March 2023.

Source: www.urgo.de
As of August 2023