Foreword
iv
EM3 AEM Monitor User’s Guide
Active Accessories and AEM Monitor
WARNING
These devices have been specifically designed for use in electrosurgery. Do not use for other
procedures.
Do not wrap accessory cords around metal objects. Wrapping cords around metal objects may induce
currents that could lead to shocks, fires, or injury.
The electrode tip may remain hot enough to cause burns after the electrosurgical current is
deactivated.
When not in use, place accessories in a clean, dry, nonconductive and highly visible area not touching
the patient. Inadvertent contact with the patient may result in burns.
Inadvertent activation or movement of the activated electrode tip outside the field of vision may result
in injury to the patient. Use these instruments only under conditions that ensure adequate
visualization.
Localized burns to the patient or physician may come from electrical currents carried through
conductive objects (such as cannulas or scopes). Electrical current may be generated in conductive
objects by direct contact with the active accessory cable being in close proximity to the conductive
object.
Ensure that the insulation of conventional, nonshielded disposable and reusable laparoscopic
instrumentation is intact. Compromised insulation of nonshielded instruments may lead to shocks or
burns to the patient or surgical personnel.
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.
Refer to the cannula manufacturer’s instructions before inserting the electrode into the cannula. To
avoid damaging the electrode or injuring the patient, insert and withdraw them carefully.
Inspect cords for breaks, cracks, nicks or other damage before every use. Verify that end of life
indicators are not present. If any of these 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 Monitor may result in a
risk of unintended patient burn. Do not use product having damaged insulation.
When an alert is presented by the AEM Monitor, 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 Monitor
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.
Good operating room practice suggests that connections of accessories to electrosurgical generators
be made only while the generator is off
or in standby mode.
Use the AEM Monitor only if the Power On Self Test (POST) has been properly completed (see
Section 3 for details). Otherwise, AEM functions may not be operative.
CAUTION
Read the instructions, warnings, and cautions provided with the AEM Monitoring System accessories before
using. Their specific instructions are not included in this manual.
AEM Monitoring will not function without the use of a dual pad return electrode and an electrosurgical
generator equipped with contact quality monitoring patient safety technology.
Limit power setting to 80 watts or lower as specified in the power settings tables (see Section 3). Higher
settings may result in spurious insulation failure alarms and/or insulation breakdown. Refer to instrument
instructions for use for other limits.