GE MAC 2000 Operator's Manual

Also see for MAC 2000: Operator's manual Service manual Reference guide

1.5.4 Certification InformationMedical EquipmentWith respect to electric shock, fire, and mechanical hazards only in accordance with UL60601–1, and CAN/CSA C22.2 NO. 601.1.This system bears CE mark 0459 indicating it conforms with the provisions of CouncilDirective 93/42/EEC concerning medical devices, and it fulfills the essential require-ments of Annex I of this directive.The system is in radio-interference protection class Bin accordance with EC 55011. Thecountry of manufactures is indicated on the equipment labeling.The product complies with the requirements of standard EN 60601–1–2 “Electromag-netic Compatibility — Medical Electrical Equipment”.The medical device has a lifetime of 7 years with respective to the Council Directive93/42/EEC essential requirement #4.1.5.5 Recording ECGs During DefibrillationThis 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 theelectrodes to retain a residual charge causing a polarization or DC offset voltage. This electrodepolarization blocks acquisition of the ECG signal. To avoid this condition, if there is a situation wherea defibrillation procedure might be necessary, use non-polarizing electrodes (which do not form a DCoffset voltage when subjected to a DC current) such as silver/silver-chloride types.If you use polarizing electrodes, GE Healthcare recommends disconnecting the leadwires from thepatient before delivering the shock.Electrode defibrillation recovery is the ability of the electrode to allow the ECG trace to return afterdefibrillation. GE Healthcare recommends using non-polarizing disposable electrodes with defibrillationrecovery ratings as specified in AAMI EC12 5.2.2.4. AAMI EC12 requires that the polarization potential ofan electrode pair does not exceed 100 mV 5 seconds after a defibrillation discharge.Refer to the supplies and accessories reference guide for this system for a list of approved electrodes.1.5.6 Accuracy of Input Signal Reproduction• Overall System Error meets AAMI EC11 3.2.7.1 requirements. Overall System Error is between orwithin ±5% or ±40 μV, whichever is greater.• Frequency Response meets AAMI EC11 3.2.7.2 requirements, using testing methods A and D.Frequency response is between or within ±10% between 0.67 and 40 Hz and between +0 and -10%for 20 ms, 1.5 mV triangular input.1.5.7 Modulating Effects in Digital SystemsThis 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 pediatricOperator Manual 1.5 Regulatory and Safety Information2053535-002 Revision T MAC 2000 ECG Analysis System 16/198