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State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release
Safety Information
CAUTION: Before using the OPTIS™ Integrated Next for the first time, be sure
to read and understand all of the information in this chapter. Carefully read all
instructions prior to use. Observe all warnings and precautions noted
throughout these instructions; otherwise, complications may occur.
Although the OPTIS Integrated Next conforms to laser emission standards and
both international and European safety and electromagnetic compatibility
standards, the system is intended for use only by medical personnel who are
knowledgeable in OCT and physiology procedures. Only a knowledgeable
operator can determine if OPTIS Integrated Next use is appropriate. An
awareness of system limitations is essential to making that determination and
ensuring safe operation for both operator and patient.
This section provides information on:
Patient Safety
The OPTIS Integrated Next is intended for use only by medical personnel who
are familiar with its operation and skilled in the clinical procedures to be used.
To avoid any potential hazard to patients, follow the precautions outlined in this
section.
CAUTION: Use only the compatible Dragonfly™ Imaging Catheter with the
OPTIS Integrated Next. Use of other types of catheters may result in unsafe
conditions for the patient and damage the OPTIS Integrated Next.
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OPTIS™ Integrated Next Operation and Maintenance Manual – 600173796 Rev. A
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Patient safety
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Operator safety
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Moving the system
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Avoiding electrical hazards
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Electromagnetic interference
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Built-in safety functions
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