AAMI EC11 pdf free download

AAMI EC11 pdf free download.Diagnostic electrocardiographic devices.
2 Normative references 2.1 Applicable documents The following documents are applicable to the extent specified herein. 2.1.1 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Safe current limits for electromedical apparatus. ANSI/AAMI ES1-1985. Arlington (Vir.): AAMI, 1985. American National Standard. ISBN 0-910275-50-5. 2.1.2 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Cardiac defibrillator devices. ANSI/AAMI DF2-1989. Arlington (Vir.): AAMI, 1989. American National Standard. ISBN 0-910275-91-2. 2.2 Reference standards Reference may be made to the following standards for safety and performance criteria established for other electrocardiographic devices and for components of electrocardiographic recording systems. 2.2.1 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Cardiac monitors, heart rate meters and alarms. ANSI/AAMI EC13-1983. Arlington (Vir.): AAMI, 1983. American National Standard. ISBN 0-910275-42-4. 2.2.2 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Disposable ECG electrodes. ANSI/AAMI EC12-1991. Arlington (Vir.): AAMI, 1991. American National Standard. ISBN 0-910275-61-0. 2.2.3 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Standard for ECG connectors. ANSI/AAMI ECGC-1983. Arlington (Vir.): AAMI, 1983. American National Standard. ISBN 0-910275-21-1.3 Requirements 3.1 Labeling requirements In addition to federal regulations applicable to the labeling of all medical devices, the requirements of this section shall apply to all devices within the scope of this standard. 3.1.1 Device markings 3.1.1.1 Product identification and characteristics Diagnostic ECG devices shall be clearly and permanently marked with the following information: a) the manufacturer’s name, trademark, trade name, or other recognizable identification;b) the catalogue, style, model, or other type designation; c) the serial number; d) the range of supply (mains) voltage and the maximum operating current or power; e) the nominal supply (mains) frequency; f) the number of phases, unless the device is intended for single-phase use only; g) the current-carrying capacity of each convenience receptacle and/or identification of the instrument(s) which can be connected to it if the device provides mains power for other devices. 3.1.1.2 Panel controls and switches All controls, switches, and connectors shall be clearly and concisely labeled to identify their function. 3.1.1.3 Electrical safety Where markings are affixed to the electrocardiograph warning maintenance personnel of the potential shock hazard from accidental contact with parts, or identifying electrocardiographs with current ratings that may overload branch circuits supplying the electrocardiograph, these markings shall be placed in locations suitable for the intended use and shall be clearly visible. NOTE—Markings that are inside the enclosure of the equipment shall be considered clearly visible if they can be viewed when the connections to the supply are being made or inspected. Markings that are inside the enclosure of cord-connected equipment are considered to be clearly visible if the markings would be seen before a hazard is encountered. 3.1.1.4 Fuse holders If fuse holders accessible to the operator are provided, they shall be clearly marked with the applicable fuse rating, in amperes, and with the fuse type.3.1.1.5 Patient-electrode connection nomenclature and colors Colors, if used, shall be associated with either individually colored patient lead conductors and/or if plug bodies are used, with the bodies at the electrode ends. Cable legends of a permanent type (e.g., engraved) shall also be used for individual patient-electrode connection identification. The standard color code for patient lead conductors, as well as electrode placement, shall conform to the specifications of table 1. NOTE—See A.3.1.1 for information concerning the differences between the color code specified in this requirement and that recommended by the International Electrotechnical Commission (IEC). 3.1.2 Operator’s manual An operator’s manual, containing adequate instructions for the proper installation and the safe and effective operation of the device and identifying acceptable repair facilities, shall be provided with each unit (or in the case of multiple orders, as specified in the purchase contract). At least the following information shall be supplied.AAMI EC11 pdf download.