Biocompatibility; Responsibility Of The Manufacturer; General Information; Recording Ecgs During Defibrillation - GE MAC 600 Operator's Manual

Biocompatibility

The parts of the product described in this manual, including all accessories that are intended to
come in contact with the patient during the intended use, fulfill the biocompatibility requirements of
the applicable standards. Please contact GE Healthcare or its representatives with any questions.

Responsibility of the Manufacturer

GE Healthcare is responsible for the effects of safety, reliability and performance only if:
Assembly operations, extensions, readjustments, modifications, or repairs are carried out by
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persons authorized by GE Healthcare.
The electrical installation of the relevant room complies with the requirements of the appropriate
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regulations.
The equipment is used in accordance with the instructions for use.
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General Information

Recording ECGs during Defibrillation

This equipment is protected against the effects of cardiac defibrillator discharge to ensure
recovery, as required by test standards.
The patient signal input of the acquisition module is defibrillation-proof. Therefore, it is not
necessary to remove the ECG electrodes prior to defibrillation.
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 will block acquisition of the ECG signal. To avoid this condition, use non-polarizing
electrodes (which will not form a DC offset voltage when subjected to a DC current) such as
silver/silver-chloride types, if there is a situation where there is a likelihood that a defibrillation
procedure will be necessary.
If polarizing electrodes are used, we recommend disconnecting the leadwires from the patient
before delivering the shock.
2047426-001K MAC™ 600
Introduction
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