AEM EndoShield
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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, 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 AEM
EndoShield Burn Protection System may result in a risk of unintended patient
burn. Do not use product having damaged insulation.
When an alert is presented by AEM EndoShield, discontinue use of the
electrosurgical current immediately. Find the cause of the alert and correct it
before continuing use.
Damaged internal insulation of the instrument, or loss of shield continuity, may
cause AEM EndoShield 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 AEM
EndoShield Burn Protection System accessories before using. Their specii 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.
This product is supplied sterile and is not intended for use more than one time.
No attempt should be made to reprocess this device.
Electromagnetic Compatibility (EMC) Hazards
For EMC specii cation tables, refer to the
Technical Specifi cations
section.
Caution:
Use of accessories, transducers, and cables other than those specii 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.
