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Lifting Columns | 6 Important information LINAK ® products, within the scope of this manual, are not classified as medical electrical equipment or sys- tems, nor do they fall within the scope of the EU Medical Device Directive/Regulation or other similar na- tional regulations. The products are components to be built into a piece of medical electrical equipment by a manufacturer. To support the assessment and certification task of the complete medical electrical equipment or system worldwide, LINAK provides certification, on a component level, according to the IEC 60601-1, (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) as recognised components by NRTL (Nationally Recognized Testing Laboratories). Description of the various signs used in this manual: Warnings Failure to comply with these instructions may result in accidents involving serious personal injury. Recommendations Failing to follow these instructions can result in product damage. Please read the following safety information carefully: Ensure that all staff who are to connect, mount, or use the actuator system are in possession of the necessary information and that they have access to these assembly instructions. Persons who do not have the necessary experience or knowledge of LINAK products should not use these. Moreover, persons with reduced physical or mental abilities must not use the products, unless they are under surveillance or they have been thoroughly instructed in the use of the equipment by a person who is responsible for the safety of these persons. Moreover, children must be under surveillance to ensure that they do not play with the product. Please be aware that LINAK has taken precautions to ensure the safety of the actuator system. The manufacturer/OEM is responsible for the overall approval of the complete application. LINAK recommends to use the actuators in push applications rather than pull applications. LINAK actuators are not to be used for repeated dynamic push-to-pull movements. For general pull applications or repeated dynamic push-to-pull movements in the application, please contact LINAK A/S if in doubt. LINAK actuators and electronics generally fall outside the IEC 60601-1 definition of applied parts and are not marked as such. However, assessing the risk whether actuators and electronics can unintentionally come into contact with the patient, determines that they are subject to the requirements for applied parts. All the relevant requirements and tests of the standard are carried out as part of the IEC CB* Scheme/NRTL** assessment. * CB: Certification Body **NRTL: Nationally Recognised Testing Laboratory
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Lifting Columns | 7 General warnings Failure to comply with these instructions may result in accidents involving serious personal injury: The medical device manufacturer is responsible for the incorporation of a suitable safety arrangement, if the actuator or lifting column is used for pull in an application where personal injury can occur, which will prevent personal injury from occurring in case of actuator failure. Note that during construction of applications, in which the actuator is to be fitted, there must be no possibility of personal injury, for example the squeezing of fingers or arms. The plastic parts in the system cannot tolerate cutting oil. Assure free space for movement of the application in both directions to avoid a blockade. The application and actuators are only to be operated by instructed personnel. In applications with spline function, the blockage by an obstacle when the application is moving inwards, the removal of the obstacle will cause the load to drop until the spindle hits the nut. Do not turn the outer tube. Do not use chemicals. Inspect the actuator system regularly for damage and wear. Do not expose LINAK actuator system components to high intensity ultraviolet radiation disinfection lamps. This may damage the enclosure, supporting parts and cables. LINAK actuators and electronics are not designed for use within the following fields: • In the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide • Planes and other aircrafts • Explosive environments • Nuclear power generation If faults are observed, the products must be replaced.
