Use Instructions

Extravasation of the photosensitizer may cause burns and other severe

reactions in the tissue, especially if the affected area is exposed to light.

Please refer to the prescribing information of the drug for instructions.

ML6710i is a combination equipment utilizing a photochemical reaction between laser light and a

photosensitive drug. Patient exposure to laser light elsewhere than the tissue planned to be treated

should be avoided to minimize unnecessary drug activation. Please pay attention to laser safety

precautions described in these Instructions For Use to avoid laser hazards. Please refer to prescribing

information of the drug for possible contraindications and side effects from using the drug.

Follow the recommended light dose instructed in the prescribing information

when setting the treatment parameters for the ML6710i.

Patient shall be instructed to avoid exposure to direct sunlight or bright

indoor light according to the prescribing information of the drug.

ML6710i shall not be used when the intended use or the indication for use of ML6710i

do not coincide with the intended use or the indication for use of the photosensitizer.

The device is not meant to be in contact with human tissue

and unnecessary contact should be avoided.

Changes or modifications not expressly approved by the manufacturer

could void the user’s authority to operate the equipment.

Federal law restricts this device to sale by or on the order of a physician.

WARNING

C A U T IO N

WARNING

ML6710i Instructions For Use

8 Information for safety