3: Operating the Device Safety Considerations
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Safety Considerations
The following general warnings and cautions apply to the use of the Efficia DFM100. Additional
warnings and cautions specific to a particular feature are provided in the appropriate sections.
WARNINGS: The Efficia DFM100 is not intended to be deployed in settings or situations that promote use by
untrained personnel. Operation by untrained personnel can result in injury or death.
Use of the Efficia DFM100 is restricted to a single patient at a time.
Algorithms in the Efficia DFM100 use the currently set Paced Status during rhythm analysis.
Confirm that the patient’s paced status is correct.
When transporting a patient or carrying the Efficia DFM100, it is important to position it with the
display facing away from the body or other surfaces. If not, the Therapy and Smart Select knobs may
be bumped and inadvertently moved from their desired position.
Never operate the Efficia DFM100 in standing water. Do not immerse or pour fluids on any portion
of the Efficia DFM100. If the device does get wet, dry it with a towel.
Do not use the Efficia DFM100 in the presence of a flammable anesthetic mixture or oxygen
concentrations greater than 25% (or partial pressures greater than 27.5 kPa/206.27 mmHg). This
can cause an explosion hazard.
Avoid connecting the patient to several devices at once. Leakage current limits may be exceeded. Do
not use a second defibrillator on the patient while pacing with the Efficia DFM100.
Operating the Efficia DFM100 or its accessories in conditions outside the environmental
specifications can result in device or accessory malfunction. The Efficia DFM100 should be allowed
to stabilize within the operating temperature range for 30 minutes prior to operation.
The Efficia DFM100 should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, the Efficia DFM100 should be observed to verify normal operation in the
configured use.
Use only 3-wire AC power cords with 3-pronged grounded plugs.
Do not touch the communication ports and a patient simultaneously.
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