Safety Information
WARNING
Repeated or long-term use of silver may cause argyria (skin and mucous membranes become stained and turn gray).
CONTRAINDICATIONS
➢ Do not use Procellera if you are sensitive or allergic to silver, zinc, and/or polyester.
➢ Do not use Procellera during Magnetic Resonance Imaging (MRI) exam.
➢ Do not use Procellera for an actively bleeding wound.
PRECAUTIONS
➢ Procellera™ should be used under the supervision of a qualified health care professional.
➢ The safety of use longer than 28 days has not been studied.
➢ For external use only.
➢ Single use only.
➢ Do not use if the immediate product packaging is open and/or damaged prior to use.
➢ Procellera may be used on infected wounds under the supervision of a physician.
➢ Avoid contact with electrodes or conductive gels during electronic measurements; e.g., EEG or ECG.
➢ Do not use Procellera during energy-based procedures or delivery systems (such as electricity, radiofrequencies, ultrasound, radiation, etc.) where the dressing may interfere with delivery.
➢ Do not use Procellera with topical agents such as antimicrobial ointments, enzymatic debriders, antibiotic creams, silver or zinc containing creams, oxidizing agents, petroleum based products, etc.
➢Secondary dressings should be used as stated in their Instructions for Use.
➢The patient should stop using the dressing and consult a physician if allergy, irritation, increased pain or any irregular skin discoloration occur.
SITE CARE
Inspect the wound site periodically. Stop using the dressing and consult a physician if you have an allergic reaction or if redness, irritation, swelling, infection or pain develops.
Procellera may be left in place for up to 7 days. Earlier or more frequent changes might be required, as indicated by your physician.