FujiFilm EB-530US - Important Safety Information; Intended Use of Ultrasonic Endoscope; General Safety Guidelines; Critical Safety Warnings and Cautions

Important Safety Information
For the USA Market - CAUTION:
Federal law restricts this device to sale by or on the order of a physician.
1. Intended Use
This product is a medical Ultrasonic Endoscope to be used under the control of doctors
in medical facilities for the observation, diagnosis and medical treatment of tracheae
and bronchi, as well as the inspection of tracheae, bronchi and adjacent organs, using
ultrasonic imaging. Never use this product for any other purpose. This product is not
intended for use on children and infants.
2. Safety
Read and understand this manual carefully before use. Use the Ultrasonic Endoscope
by following the provided instructions. Items important for the safe use of the
Ultrasonic Endoscope are summarized in Chapter 1 “Safety.”
Safety precautions associated with individual operations or procedures are provided
separately, indicated “ WARNING” or “ CAUTION.”
3. Warning
Items that must be observed for safety when performing endoscopy or electrosurgery
are identied by “ WARNING” or “ CAUTION.” Perform procedures correctly by
reading and understanding the warning information carefully.
WARNING
Read and understand this manual carefully before
operating the equipment.
Improper use or operation of the equipment may
injure patients, physicians, or people in the vicinity.
Improper operations that will damage the equipment only are identified by
“CAUTION.”
4. About Clinical Procedures
This manual assumes that the product will be used by medical specialists who have
received proper training in ultrasonic endoscopic procedures. It does not provide
information about clinical procedures. Regarding clinical procedures, use proper clini-
cal judgment.
5. When Using this Product for the First Time
This product has not been sterilized. When using it for the rst time, use the level of
disinfection or sterilization suitable to the application, in accordance with Chapter 7
“Cleaning,” Chapter 8 “Chemical Disinfection,” and Chapter 9 “Gas Sterilization.”
Important Safety Information
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