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
To Next Page
Loading...