Products that are not manufactured by Samsung Medison are indicated with the trademarks of their respective owners.
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The content of this service manual is subject to change without prior notice. Screen images in this service manual are examples and may differ from the actual screen or system.
Some functions or options, probes, and the like may not be used in certain countries.Īll reference material on standards, regulations, and related revisions are valid at the time of the publication of this service manual. Product orders are based on individually agreed specifications and may not include all functions specified in this service manual. The manufacturer is not responsible for any damage to this product caused by user carelessness and/or neglect. Unqualified persons are prohibited from using the product. This product must only be used by persons who have sufficient knowledge of and/or a qualification in clinical pathology. The manufacturer is not responsible for any problems that may be caused by such attempts. This product is an ultrasound diagnosis device and cannot be used from the user’s PC. Also, check the reference information for the measured area of the body before using the application’s measurement results in any diagnosis. This service manual does not include diagnosis results or opinions. Please familiarize yourself with the safety precautions in “Chapter 2. Keep this service manual near the product and refer to it when using the product. Precautions for Use Be sure to read this Service Manual thoroughly to familiarize yourself with the operation of the product and the relevant safety information before attempting to use the product. The GMP symbol indicates the Good Manufacturing Practice in accordance with the Korean quality management regulations. This mark certifies that the product conforms to applicable EEC standards. This mark certifies that the product conforms to applicable EEC standards and has been certified by the European certification agency. and Canadian markets, to the applicable U.S. Nemko-CCL mark with the indicators “C” and “US” means that the product is certified for both the U.S.
– Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance – Biological Evaluation of Medical Devices – Part 1: evaluation and testing – Standard Means for Reporting the Acoustic Output of Medical Diagnostic Ultrasonic Equipment Statements Safety Requirements Classification – Type of protection against electric shocks: Class I – Degree of protection against electric shocks (when the patient is in physical contact): Type BF or type CF mounting – Degree of protection against the ingress of harmful liquids: General equipment – Degree of safety of use in the presence of flammable anesthetic agent mixed with air, oxygen, or nitrous oxide: Not suitable for use near flammable anesthetic agent mixed with air, oxygen, or nitrous oxide – Mode of operation: Continuous operation Safety standards the device conforms to – Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance – Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility – Requirements and Tests – Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability – Medical Electrical Equipment - Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment – Medical Electrical Equipment - Part 1: General Requirements for Safety – Medical Electrical Equipment - Part 1-1: General Requirements for Safety – Collateral Standards: General Requirements for Medical Electrical Systems – Medical Electrical Equipment - Part 1-2: General Requirements for Safety – Collateral Standards: Electromagnetic Compatibility – Requirements and Tests – Medical Electrical Equipment - Part 1-4: General Requirements for Safety – Collateral Standards: Programmable Electrical Medical Systems – Medical Electrical Equipment - Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment – Medical Devices – Application of Risk Management to Medical Devices – Medical Electrical Equipment - Part 1: General Requirements for Safety – Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
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