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Surgical Mobile Suction Unit REXMED RSU-586

Model No.
RSU-586
Made in
Taiwan
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    Surgical Mobile Suction Unit RSU-586

    Key Features

    MOD. RSU-586, AC 110/230V, Current: 2.4/1.2A, Power consumption: 250W, Plug type: , Surgical Mobile Suction Unit with handle, ABS tray, storage box and 4 castors with 4 lockable castors, HS CODE: 901890, UNCCS CODE: 481361, UNSPSC CODE: 42142400, 42142404, 42295123, UMDNS CODE: 10217, GMDN CODE: 36777, Main construction: Cast aluminium and ABS, Plastic bottle: 2pcs x 3,000c.c. graduated at 250c.c. autoclavable at 130°C plastic bottle with silicone rubber seal, Max. suction: -10~-720 mm/Hg, Select valve: No, Vacuum control: Needle valve, Vacuum indicator: 0~-760 mm/Hg graduated at -10 mm/Hg Bourdon tube type gauge, Vacuum flow: 0~80 liter/min, Max. HP: 250W 1/3HP, Safety device: Water stop device, floating control, disposable bacterial filter >99.999% (0.3 micron) and no fuse breaker, Extra function: No, Foot control: Yes, micro switch type (ON for press, OFF for release), Noise: 60 dB, Pump: Oil-less twin piston pump with overload protection and auto reset, Cooling fan: Yes, W/S: suction tube (6x11) 180cm x 1pc, suction catheter x 1pc, filter (big) x 2pcs, foot switch x 1pc

    Product Certification

    The letters "CE" are the abbreviation of French phrase "Conformit� Europ�ene" which literally means "European Conformity". The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents.
    ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
    The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved.
    GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and E for drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time. GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business. GMP is also sometimes referred to as "cGMP". The "c" stands for "current," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent contamination, mixups, and errors, which may have been "top-of-the-line" 20 years ago, may be less than adequate by today's standards.
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