CareFusion V.Mueller Mode D'emploi page 2

US Federal Law restricts this device to sale by or on the order
of a physician only.
Catalog Numbers
All products covered by these instructions are listed in the
appendix.
Indications for Use
The Bipolar Forceps are designed to grasp, dissect and coagulate
selected tissue. They must be connected to the bipolar output of
an electrosurgical generator using a suitable bipolar cable and
must only be used with parameters for bipolar coagulation.
How Supplied
Devices are packaged as non-sterile. Cleaning and sterilization
of devices must occur prior to use.
Limitations on Reprocessing
Repeated processing has minimal effect on these devices. End
of life is normally determined by wear and damage due to use.
Contraindications
Bipolar forceps have not been shown to be effective for tubal
sterilization or tubal coagulation for sterilization procedures and
should not be used for these procedures.
Adverse events reported while using bipolar electrosurgical
devices include:
• Inadvertent activation with resultant tissue damage at the
wrong site and/or equipment damage.
• Fires involving surgical drapes and other combustible
materials have been reported.
• Alternate current pathways resulting in burns where the patient
or physician or assistant is in contact with exposed metal.
• Explosions caused by electrosurgical sparking in a
flammable gas environment (i.e. explosive anesthetic gases).
• Organ perforation. Sudden massive hemorrhage.
Warnings
Devices shall be used in accordance with these Instructions for
Use. Read all sections of this IFU prior to use. Improper use of
these devices may cause serious injury. In addition, improper
care and maintenance of the devices may render the devices
non-sterile prior to patient use and may cause serious injury to
the health care provider or the patient.
Do not exceed a maximum output of 500 Vp (or 300 Vp
respectively, depending on model; refer to catalog) of your
generator.
Cautions
If there are any variations between these Instructions for Use
and either your facility's policies and/or your cleaning/sterilizing
equipment manufacturer's instructions, those variations should
be brought to the attention of the appropriate responsible
hospital personnel for resolution before proceeding with
cleaning and sterilizing your devices.
Use of a device for a task other than what it is intended for will
usually result in a damaged or broken device.
Prior to use, inspect devices to ensure proper function and
condition. Do not use devices if they do not satisfactorily
perform their intended function or if they have physical damage.
Special safety precautions should be observed when using
electrosurgical instruments.
Never use the instruments in the presence of flammable or
explosive substances.
The instrument may not be laid down on the patient.
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