FMX Generator Directions for Use
3
English
Introduction
Domain Surgical’s FMX Ferromagnetic Surgical System is an intelligent
surgical platform that provides precise control of surgical thermal energy,
without passing any electrical current through the patient. The FMX system
consists of a generator, power module, and single-use surgical instruments.
Indications for Use
The FMX Ferromagnetic Surgical System is indicated for cutting and
coagulation of soft tissue. For specific indications of individual FMX
surgical instruments, see their respective Directions for Use.
Contraindications
For specific contraindications of individual FMX surgical
instruments, see their respective Directions for Use.
Important Information
Prior to use of the FMX system, ensure that all package inserts, including
warnings, precautions, and instructions are read and understood.
Cautions
• Federal (US) law restricts this device to sale by or on the order of a physician.
• This manual and the equipment described within are
for use only by qualified medical personnel trained
in the surgical procedures to be performed.
• Prior to initial use of the FMX system, ensure that all package inserts,
including warnings, precautions and instructions are read and understood.
Precautions
• The FMX system and components should only be used by qualified
medical personnel trained in the surgical procedures to be performed.
• Take care when handling the surgical instruments
to prevent possible damage to the tip.
• Do not use abrasive materials or metal instruments to clean
the surgical tip. This can damage the tip and cause the device
to fail to function as intended. Gauze moistened with water or
saline is recommended for removing heavy coagulum.
• Use the lowest power level and the shortest activation time
necessary to achieve the desired surgical effect.
• Prior to use, carefully inspect the FMX surgical instruments
for any defects. DO NOT USE if the packaging, cable
insulation or the connector appear damaged.
Introduction .................................................................................3
Indications for Use .......................................................................3
Contraindications ........................................................................3
Important Information .................................................................3
Cautions ......................................................................................3
Precautions ..................................................................................3
Warnings .....................................................................................4
Front Panel Layout.......................................................................4
Rear Panel Layout ........................................................................4
Generator Installation ..................................................................5
Generator Preparation .................................................................5
Generator Start-Up Instructions...................................................5
Foot Pedal Installation .................................................................5
Power Module and Surgical Instrument Installation ....................5
Preparing Generator for Use .......................................................6
Operating Instructions .................................................................6
Cleaning Instructions ...................................................................7
Generator Power-Down Instructions ...........................................7
Symbols .......................................................................................7
Specifications ..............................................................................7
Troubleshooting ..........................................................................9
Warranty ......................................................................................10
Summary of Contents for FMX
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