300-002547-00 rev7 v
serious complications (for example, collapsed lung, respiratory failure, heart attack
and/or cardiac arrhythmia).
Prescription Device Statement
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Safety Precautions and Warnings
Safe operation of the Monarch Platform requires careful attention to the serious hazards
associated with use of the device and ways to avoid or minimize the hazards, and
familiarity with emergency procedures. Untrained or careless operation of the Monarch
Platform can damage the system, its components or other property; cause poor
performance; or lead to serious bodily injury and possibly death.
Auris Health, Inc. strongly recommends that personnel be trained by Auris on the
Monarch Platform prior to use for research or clinical purposes. Only physicians having
adequate training and experience with endoscopic techniques should perform
endoscopic procedures.
Users must follow all instructions for use supplied with the system, its components,
instruments and accessories, including any instructions for use (IFUs) provided with
instruments or accessories. The IFU provided are the primary sources for detailed safety
information.
Under the conditions described in the declaration of immunity section, the system may
fault in an immobilized state. Follow the directions indicated to return to normal
operation.
System Error Messages
Under the error conditions described in Appendix B, all robotic functions are disabled.
Follow the directions indicated to return to normal operation.
Notations
This manual uses the special notations below to bring your attention to important
information.
WARNING: Describes actions or conditions that could result in injury or death.
CAUTION: Describes actions or conditions that could result in damage to the
equipment or minor harm to the user or patient.
NOTE: Provides more information about a subject.
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