GE Healthcare

MAC ECG Analysis Systems

MACi Resting ECG System Guides Rev C

System Guide

8 Pages

MAC™ i Resting ECG System-Safety and Warnings Guide © 2009, 2011, General Electric Company. All Rights Reserved  The MAC™i Resting ECG System Safety and Warnings Guide provides guide details, safety information and symbols definitions.  Guides information The MACi Resting ECG System Guides contain the instructions necessary for operating the MACi system in accordance with its function and intended use. The information in these guides only applies to MACi system software version 1.10. It does not apply to earlier software versions. Due to continuing product innovation, specifications in these guides are subject to change without notice. MAC™ and 12SL™ are trademarks owned by GE Medical Systems Information Technologies, a General Electric Company going to market as GE Healthcare. All other marks are owned by their respective owners.  INTENDED AUDIENCE The MACi Resting ECG System Guides are intended for persons who use, maintain, or troubleshoot this equipment.  REVISION HISTORY The document part number and revision letter are at the bottom of each page. The revision letter identifies the documents’s update level. Revision History 2047427-001 Revision  Date  Comment  A  28 July 2009  Initial Release of document.  B  20 July 2011  Release of version 1.10 per SPR HCSDM00083102.  C  18 October 2011  Added a new Electromagnetic Compatibility section to this document.  PRODUCT REFERENCE The product described in these guides is the MACi resting ECG system. It may be referred to as “the system” throughout these documents.  The system is classified, according to IEC 60601-1, as: Class II internally powered equipment.  Degree of protection against electrical shock.  Type CF defibrillation-proof applied part.  Indicates keys and printed text on the keypad, text to be entered or hardware items such as keys or switches on the equipment.  Degree of protection against harmful ingress of water.  Ordinary equipment (enclosed equipment without protection against ingress of water, IPX0).  Indicates terms that identify menu items or options in the system display window.  Degree of safety of application in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide.  Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.  Methods of sterilization or disinfection recommended by the manufacturer.  Not applicable.  Mode of operation.  Continuous operation.  These conventions are used in the MACi system guides:  Italicized text  CLASSIFICATION  Type of protection against electrical shock.  CONVENTIONS Bold text  patibility (EMC) Standard EN60601-1-2 for Radiated Immunity (field strengths above 3 volts per meter) may cause waveform distortions. Portable and mobile RF communications equipment can affect medical electrical equipment. Users should consider RF sources, such as radio or TV stations and hand-held or mobile two-way radios, when installing a medical device or system. Adding accessories or components, or modifying the medical device or system may degrade the EMI performance. Consult with qualified personnel regarding changes to the system configuration. Medical electrical equipment requires precautions regarding EMC and needs to be installed and used according to the EMC information provided in the product service manual. The use of accessories, transducers and cables other than those specified or sold by the manufacturer may result in increased emissions or decreased immunity of the system. The system should not be used nearby or stacked with other equipment. If stacking or using near other equipment cannot be avoided, observe to verify normal operation. Review the AAMI Committee Technical Information Report (TIR) 18, “Guidance on Electromagnetic Compatibility of Medical Devices for Clinical/Biomedical Engineers” for details on evaluating and managing an EMI environment in the hospital. Take the following actions to reduce the risk of medical device EMI and achieve EMC: • Assess the EMC environment of the facility and identify radio transmitters and/or areas where critical medical devices are used such as the emergency room and intensive care units. • Increase the distance between sources of EMI and susceptible devices. • Remove the devices that are highly susceptible to EMI. • Lower the power transmitted from electrical and electronic equipment (EMI sources) under hospital control (i.e. paging systems). • Label devices susceptible to EMI. • Educate facility staff (nurses and doctors) to identify, and recognize, potential EMI-related problems.  CE marking information The MACi system bears the CE mark “CE-0459” notified body GMED, indicating its conformity with the provisions of the Council Directive 93/42/ EEC, concerning medical devices and fulfills the essential requirements of Annex I of this directive. The system delivers 1 channel recording and has an option of 3 channel recording in ECG mode and only 1 channel recording in Rhythm mode. The country of manufacture can be found on the equipment labeling. The safety and effectiveness of this system have been verified against previously distributed devices. All standards applicable to presently marketed devices may not be appropriate for prior devices (for example, electromagnetic compatibility standards). This system will not impair the safe and effective use of previously distributed devices. NOTE: Electromagnetic compatibility information can be found in the “MACi Resting ECG System Service Manual”.  Product use and classification RECOMMENDATIONS  INTENDED USE 1. MACi is intended to be an ECG acquisition, analysis and recording system designed and manufactured by GE Healthcare. 2. MACi is intended for use under the direct supervision of a licensed healthcare practitioner. 3. Trained operators in small and medium hospitals will use MACi to record ECG signals from surface electrodes. 4. MACi is intended to acquire, record and measure electrocardiogram information from adult and pediatric populations. 5. The basic system delivers 12 leads ECG in print. 6. MACi is not intended for use as a vital signs physiological monitor. 7. MACi is not intended for use during patient transport. 8. MACi is not intended for intra cardiac application.  Warning Electrodes  Polarizing electrodes (stainless steel or silver constructed) may cause the electrodes to retain a residual charge after defibrillation. A residual charge will block acquisition of the ECG signal. Whenever patient defibrillation is a possibility, use non polarizing (silver/ silver chloride construction) electrodes for ECG monitoring.  Magnetic and electrical interference  Magnetic and electric fields can interfere with proper electrical performances of the system. Make sure that all external interference devices operated near the system comply with the relevant EMC requirements. X-ray equipment or MRI devices may interfere with system performance because they may emit higher levels of electromagnetic radiation.  Explosion hazard  Do NOT use in the presence of flammable anesthetics vapors or liquids.  Operator  Medical technical equipment such as this electrocardiograph system must only be used by persons who have received adequate training in the use of such equipment and are capable of applying it properly. The MACi system is for use under the direct supervision of a licensed healthcare practitioner who has received proper medical and product training.  Shock hazard  Improper use of this system presents a shock hazard. Failure to observe the following warnings may endanger the lives of the patient, the user, and bystanders. Disconnect from the power source before disconnecting the cable from the system to reduce the risk of inadvertently introducing metal parts in the sockets of the power cord. Care should be taken to make sure electrode cables are not connected to AC power outlet.  Site requirements  Do not route cables in a way that they may present a stumbling hazard. For safety reasons, connectors for patient cables and lead wires are designed to prevent disconnection if pulled on. For devices installed above the patient, adequate precautions must be taken to prevent them from dropping on the patient.  Accessories  To ensure patient safety, use only parts and accessories (supplies) manufactured or recommended by GE. Parts and accessories must meet the requirements of the applicable IEC 60601 series safety standards and essential performance standards.  Interpretation hazard  Computerized interpretation is only significant when used in conjunction with clinical findings. A qualified physician must overread all computer-generated tracings.  The basic portable MACi system delivers 1 channel recording and has an option of 3 channel recording in ECG mode and only 1 channel recording in Rhythm mode.  BIOCOMPATIBILITY The parts of the product described in these guides, including all accessories, that 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.  Safety information DEFINITIONS The terms danger, warning, and caution are used in these guides to point out hazards and to designate a degree or level of seriousness. Familiarize yourself with their definitions and significance. A hazard is defined as a source of potential injury to a person. DANGER indicates an imminent hazard which, if not avoided, will result in death or serious injury. WARNING indicates a potential hazard or unsafe practice which, if not avoided, could result in death or serious injury. CAUTION indicates a potential hazard or unsafe practice which, if not avoided, could result in personal injury or product/property damage. NOTE provides application tips or other useful information to ensure that you get the most from your equipment. The safety information given in this manual is classified as follows. Warning  Description  Accidental spills  To avoid electric shock or system malfunction, liquids must not enter the system. If liquids enter the system, switch off the device and inform Service.  Cables  To avoid possible strangulation, route all cables away from patient's throat.  Connection to mains  This is Class II equipment. The mains plug must be connected to an appropriate power supply.  Defibrillator  Do not come into contact with patients during defibrillation. Serious injury or death could result. Patient signal inputs labeled with the CF or BF symbols with paddles are protected against damage resulting from defibrillation voltages. To ensure proper defibrillator protection, use only the recommended cables and lead wires. Proper placement of defibrillator paddles in relation to the electrodes is required to ensure successful defibrillation.  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 persons authorized by GE Healthcare. • 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.  Description  Operating the system near radio frequency (RF) electromagnetic interference (EMI) above the conditions defined in the electromagnetic com-  MACi Resting ECG System Guides 0459  2047427-001  Page 1 of 8 Revision C
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