2042480-001 C Dash 2500 Patient Monitor 9-5
ECG: Indications and Contraindications
WARNING
This device uses a computerized 3-electrode ECG analysis
program which can be used as a tool in ECG tracing
interpretation. This computerized interpretation is only
significant when used in conjunction with clinical findings. All
computer generated tracings should be overread by a
qualified physician.
CAUTIONS
Inaccurate heart rates caused by missing QRS complexes, or
counting non-QRS events, may result if ECG amplitude is low.
Pacemaker spikes occurring less than 40 ms prior to the peak
of a QRS complex will cause that QRS not to be counted in the
heart rate.
Use only electrodes, lead wires, and cables recommended by
GE Medical Systems Information Technologies. Failure to use
recommended accessories may result in inaccurate readings,
damage to equipment, or loss of defibrillator protection.
The summation of leakage currents when several items of
equipment are interconnected, may pose a possible hazard.
Route cables away from patient's throat to avoid possible
strangulation.
ECG electrodes are tested to and meet the biocompatibility
requirements of ISO 10993.
FDA POSTMARKET SAFETY ALERT – the United States FDA
Center for Devices and Radiological Health issued a safety
bulletin October 14, 1998. This bulletin states "that minute
ventilation rate-adaptive implantable pacemakers can
occasionally interact with certain cardiac monitoring and
diagnostic equipment, causing the pacemakers to pace at
their maximum programmed rate." The FDA further
recommends precautions to take into consideration for
patients with these types of pacemakers. These precautions
include disabling the rate responsive mode and enabling an
alternate pace mode. For more information contact:
Office of Surveillance and Biometrics, CDRH, FDA
1350 Piccard Drive, Mail Stop HFZ-510
Rockville, MD 20850
USA
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