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Intended Purpose

Disposable medical protective coverall clothing is intended to be worn by health care personnel during medical procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, secretions of the patients and particulate matter.

Disposable medical protective coverall clothing may also be worn by patients and other persons to reduce the risk of spread of infections, particularly in epidemic or pandemic situations.

Specification

The disposable medical protective coverall clothing is developed, manufactured and tested in accordance with Type 4-B of EN 14126. Performance against penetration by infective agents is realized by

1. Resistance to penetration by contaminated liquids under hydrostatic pressure;

2. Resistance to penetration by infective agents due to mechanical contact with Substances containing contaminated liquids;

3. Resistance to penetration by contaminated liquid aerosols;

4. Resistance to penetration by contaminated solid particles.

Contraindications

The disposable medical protective coverall clothing is not intended for invasive surgical procedures.

Do not use the disposable medical protective coverall clothing when pathogen resistance is needed or severe infectious diseases are suspected.

Cautions and Warnings

1. This clothing is not a surgical isolation gown. Do not use the disposable medical protective coverall clothing when there is a medium to high risk of contamination and larger critical zones of the gown are required.

2. Wearing the disposable medical protective coverall clothing does not provide complete, guaranteed protection against all contamination risks. It is also essential that you put on and remove the gown correctly to ensure safety. Any person who assists in the removal of the clothing is also exposed to the risk of contamination.

3. Inspect gown before the use to ensure that it is in good operating condition. Ensure there are no holes and no damage has occurred. The gown should be disposed of immediately upon observation of damage or missing parts.

4. Change the gown timely. Replace the gown immediately if it is damaged or soiled or contaminated with blood or body fluids.

5. Dispose of used product in accordance with applicable regulations.

6. This is single-use device. A reprocessing and re-use of the device is not allowed. An infection or transmission of diseases could occur, if the device were to be re-used.