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Warnings and Cautions (continued)
When using laparoscopic instrumentation with metal cannulas, the potential
exists for abdominal wall burns to occur in the event of direct electrode tip
contact to the cannula.
Inspect cords for breaks, cracks, and/or nicks. If any are present, do not use.
Failure to observe this precaution may result in injury or electrical shock to the
patient or operating personnel.
Damaged external insulation on instruments AND incorrect setup of the
EndoShield 2 may result in a risk of unintended patient burn. Do not use
product having damaged insulation.
When an alarm is presented by the EndoShield 2, discontinue use of
electrosurgery immediately. Find the cause of the alarm and correct it before
continuing use.
Damaged internal insulation of the instrument, or loss of shield continuity, may
activate the EndoShield 2 alarms. For maximum patient safety, discontinue use
of the instrument if this occurs.
A single AEM instrument must be the sole conductor of energy to tissue. Do
not conduct energy by touching an AEM instrument to a second instrument
contacting tissue. The second device will not be protected from capacitive
coupling and insulation failure.
Caution:
Read the instructions, warnings, and cautions provided with the EndoShield
2 accessories before using. Their specifi c instructions are not included in this
manual.
AEM Monitoring will not function without the use of a dual-area patient return
electrode and an electrosurgical generator equipped with contact quality
monitoring patient safety technology.
No attempt should be made to reprocess this device.
Electromagnetic Compatibility (EMC) Hazards
For EMC specifi cation tables, refer to the
Technical Specifi cations
section.
Caution:
Use of accessories, transducers, and cables other than those specifi ed, with
the exception of transducers and cables sold by the manufacturer of the
Equipment or System as replacement parts for internal components, may
result in increased Emissions, or decreased Immunity of the Equipment
or System.