Safety Manual

Regulatory Information
When using stainless steel or silver electrodes, a defibrillator discharge current may
cause the electrodes to retain a residual charge causing a polarization or DC offset
voltage. This electrode polarization blocks acquisition of the ECG signal. To avoid this
condition, if there is a situation where a defibrillation procedure is necessary, use
non-polarizing electrodes such as silver/silver-chloride types, which do not form a DC
offset voltage when subjected to a DC current.
If you use polarizing electrodes, GE Healthcare recommends disconnecting the
leadwires from the patient before delivering the shock.
Electrode defibrillation recovery is the ability of the electrode to allow the ECG trace
to return after defibrillation. GE Healthcare recommends using non-polarizing
disposable electrodes with defibrillation recovery rating as specified in AAMI
EC12.5.2.2.4. AAMI EC12 requires that the polarization potential of an electrode pair
does not exceed 100 mV 5 seconds after a defibrillation discharge.
Refer to the supplies and accessories guide for this system for a list of approved
electrodes.
Modulating Effects in Digital Systems
This section describes the modulating effects that may occur in digital systems of the
product.
This device uses digital sampling techniques that may produce some variation in
amplitudes of Q, R, and/or S waves from one heart beat to the next, which may be
particularly noticeable in pediatric recordings. If you observe this phenomenon,
be aware that the origin of amplitude variations is not entirely physiological. For
measuring voltages of Q, R, and S waves, GE Healthcare advises using the QRS
complexes with the largest deflection of the particular waves.
Biocompatibility
The parts of the system described in this manual that come into contact with the
patient during the intended use, including all accessories, fulfill the biocompatibility
requirements of the applicable standards. If you have questions in this matter contact
your GE Healthcare representative.
Legal Notice
GE Healthcare software contains several fields that can be populated before
performing an ECG. Some of these fields are required, others are optional and
left to the user to assess whether they are needed to perform the exam. The field
Race is one of these optional fields. Race has been acknowledged by the medical
profession as useful to analyze some pathologies. You should be aware that, in some
jurisdictions, the processing of data revealing an individual’s racial origin is subject
to legal requirements, such as obtaining the patient’s prior consent. If you elect to
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