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Mobile Stand LED Surgical Lamp REXMED ROL-601S

Model No.
ROL-601S
Made in
Taiwan
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    LED Surgical Lamp REXMED ROL-601S

    Key Features

    MOD. ROL-601S, AC 100~240V, Current: 3A, Power consumption: 36W, Plug type: , Mobile Stand LED Surgical Lamp, HS CODE: 940540, UNCCS CODE: 468304, UNSPSC CODE: 39101602, UMDNS CODE: 12282, GMDN CODE: 37332, Main construction: Cast aluminium and powder coated steel, Snake hose: No, Lamp head: Single dome LED surgical lamp 62cm, Reflector: 6cm aluminium reflector x 36pcs, Lamp head cover: 4,760 lenses / transparent lenses polycarbonate reflector, Bulb specifications: LED 1W x 36pcs x 1, Bulb life time: 50,000 hrs ±10%, Colour temperature: 4,300K, CRI Ra: 94 ±3, R9: 93 ±3, Working distance: 60~180cm, Depth of light (L1+L2): 120cm, Intensity (1meter): 0~165,000 Lux/1m, Focus (1meter): 15~25cm by sterilizable handle, Light field: d10=18.5cm, d50=15.5cm, d50/d10=84%, MIS / Endo light intensity: 0~29,000 Lux/1m, IEC with one mask: 51.00%, IEC with two masks: 42.00%, IEC with one tube: 88.80%, IEC with one mask and one tube: 42.00%, IEC with two masks and one tube: 38.00%, Swivel radius: Movement, Lamp head elevation: 105cm 15°up/75°down, Lamp head rotation: 360°, Base: 4 castors with 2 lockable castors, Control: ON/OFF switch, MIS / Endo light switch, intensity 0~100% dimmer control on copula, Surgeon head temperature: < 0.5°C, Radiation energy: < 2.6mW/m².Lux, W/S: sterilizable handle x 1pc

    Product Certification

    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.
    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.
    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.
    CE Marking (EU Standards) The safety mark is a mandatory conformity mark on designated products placed on the single market in the European Union (EU). This mark is possible to be affixed to only the products that conform to the safety regulation, that the directives from the ministerial conference of the European Communities show.
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