Responsibility Of The Manufacturer; General Information; Recording Ecgs During Defibrillation - GE MAC 800 Operator's Manual

Resting ecg analysis system
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Responsibility of the Manufacturer

General Information

Recording ECGs During Defibrillation

2031504-182F
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 collect this type of data, it is your responsibility to ensure that
you comply with all applicable legal requirements.
GE is responsible for the effects of safety, reliability, and performance
only if:
Assembly operations, extensions, readjustments, modifications, or
repairs are carried out by persons authorized by GE.
The electrical installation of the relevant room complies with the
requirements of the appropriate regulations.
The equipment is used in accordance with the instructions for use.
It is not necessary to remove the ECG electrodes prior to defibrillation;
the patient signal is defibrilation-proof.
Use silver-silver chloride electrodes. A defibrillator discharge may cause
stainless steel or silver electrodes to retain a residual charge, which
could cause a polarization that will block the acquisition of the ECG
signal for several minutes.
We recommend using non-polarizing disposable electrodes with
defibrillation recovery ratings as specified in AAMI EC 12.3.2.2.4
(SilverTRACE family of electrodes). AAMI EC12 requires that the
polarization potential of an electrode pair does not exceed 100 mV
5 seconds after a defibrillation discharge.
If other electrodes are used, disconnect the patient cable from the system
before delivering the defibrillation shock.
NOTE
If excessive DC voltages are present at the electrode, then a message
will appear indicating a Lead Off condition.
ADS (cubic spline correction) can cause a signal delay of approximately 2
seconds; therefore they should be disabled if the patient has to be
defibrillated while the ECG is being recorded.
MAC™ 800 Resting ECG Analysis System
Introduction
1-11

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