Regulatory and Safety Information
CAUTION:
EQUIPMENT FAILURE - Polarizing electrodes (stainless steel or silver constructed)
may cause the electrodes to retain a residual charge after defibrillation. A residual
charge blocks acquisition of the ECG signal.
Whenever patient defibrillation is a possibility, use non-polarizing electrodes
(silver-silver chloride construction) for ECG monitoring.
WARNING:
PERSONAL INJURY - Contact with patients during defibrillation can cause serious
injury or death.
Do not contact patients during defibrillation. Patient signal inputs labeled with
the CF symbols with paddles are protected against damage resulting from
defibrillation voltages. To ensure proper defibrillator protection, use only GE
Healthcare recommended cables and leadwires. Proper placement of defibrillator
paddles in relation to the electrodes is required to ensure successful defibrillation.
CAUTION:
EXPLOSION HAZARD - Do NOT use in the presence of flammable anesthetics
vapors or liquids.
WARNING:
INTERPRETATION HAZARD - Results of the automated QT analysis are not
considered a diagnosis.
A qualified physician or cardiologist must review and confirm the measurements
and waveforms recorded by the system. It should be used only as an adjunct to
the clinical history, symptoms, and results of other tests.
WARNING:
INTERPRETATION HAZARD - Computerized interpretation is only significant when
used in conjunction with clinical findings.
A qualified physician must overread all computer-generated tracings.
WARNING:
IMPROPER USE - This is a prescriptive device.
This equipment is intended for use by or under the direct supervision of a licensed
healthcare practitioner.
NOTICE:
BATTERY EXPLOSION HAZARD - Batteries may explode in fires.
Do not dispose of the battery by fire or burning. Follow local environmental
guidelines concerning disposal and recycling.
342  MAC
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