Intended Users; Safety Information - Integra CUSA Clarity Operator's Manual

Contraindications
Contraindication

Intended Users

Safety Information

1-2
This ultrasonic surgical aspirator device is not indicated for and should not
be used for the fragmentation, emulsification, and aspiration of uterine
fibroids.
You should use the CUSA Clarity system only in a surgical environment
by qualified medical professionals trained in the use of this equipment.
This system must be set up/disassembled by operating room (OR) staff
(for example, surgical nurse, neuro technician). The OR staff is also likely
to operate the device controls. The handpiece and footswitch are
controlled by the surgeon.
WARNING
It is the responsibility of the Healthcare Facility to ensure that intended
users of the CUSA Clarity system are appropriately trained in the use of
this equipment.
The safe and effective use of ultrasonic surgery depends to a large
degree on factors solely under the control of the operator. Only medical
professionals that are properly trained in the use of ultrasonic equipment
should operate the CUSA Clarity system. It is important that medical
professionals read, understand, and follow the operating instructions
supplied with this equipment.
Before starting any surgical procedure, medical professionals should be
familiar with the medical literature, complications, and hazards of using
ultrasonic surgery in that procedure.
CUSA
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Clarity Ultrasonic Surgical Aspirator System Operator's Manual