Because of noise, artifact and the many different physiological manifestations of the ECG signal, it is inevitable
that some beats are not detected or correctly classified by the system. The user is advised not to rely completely
on automatic alarm systems for the monitoring of critical patients.
Warnings for Patients with Pacemakers
Rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias.
Do not rely entirely upon rate meter alarms. Keep pacemaker patients under close surveillance.
When using the 3/5 lead ECG cable, pacemaker spikes are normally recognized and rejected by the software.
Signals are recognized as pacemaker spikes when they have a slew rate over 1.4 V/s, as measured according to
the ANSI/AAMI EC 13 and IEC 60601-2-27 standards.
When using the AM12M 12-lead ECG Acquisition Module, pacemaker spikes in the range of 0.3 to 1.3 mS, +/-
2 to +/-700 mV are recognized and rejected according to the ANSI/AAMI EC13 and IEC 60601-2-
27:2011standards.
The pacemaker rejection software can be deactivated by the user. This should not be done for patients with a
pacemaker or suspected to have a pacemaker implanted because this can lead to a heart rate indication and
failure to alarm for cardiac arrest.
Other than the influence on beat detection as stated above, there is no known safety hazard if other equipment,
such as pacemakers or other stimulators, is used simultaneously with the system.
Respiration Warnings
When using an ECG electrode to calculate respiration rate via the thorax impedance method, movement artifacts
may create inaccurate results. Respiration rates derived from CO2 parameter is not subject to such movement
artifacts.
SpO2 Warnings
Use only approved pulse oximetry sensors specifically intended for use with the patient monitor. Unapproved
components can result in degraded performance and/or device malfunction.
Use pulse oximetry sensors specified for the correct patient mode and for the correct application position.
Pulse oximetry sensors must be checked a minimum of every 4 hours and moved to a new site as necessary.
Reposition the sensor at least once every 24 hours to allow the patient’s skin to breathe.
Tissue damage or inaccurate measurements may be caused by incorrect SpO2 sensor application or use, such as
To Next Page