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Controls | 6 DECLARATION OF INCORPORATION OF PARTLY COMPLETED MACHINERY LINAK A/S Smedevænget 8 DK - 6430 Nordborg LINAK A/S hereby declares that LINAK DESKLINE ® products, characterised by the following models and types: Control Boxes Linear Actuators Lifting Columns Desk Panels Wireless Controls Accessories CBD6S DB5, DB6, DB14, LA23, LA31 DL1A, DL2, DL4S, DL5, DL6, DL8, DL9, DL10, DL11, DL12, DL14, DL15, DL16, DL17, DL18, DL19, DL20, DL21, BASE1, LC1 DPA, DPB, DPH, DPF, DPG, DPT, DP, DP1CS, DPI BP10 BA001, BLE2LIN, CHUSB, DESK Sensor, DF2, Kick & Click, SLS, SMPS, USB2LIN, WiFi2LIN, DC Connector, RFRL LINAK A/S hereby declares that LINAK HOMELINE ® products, characterised by the following models and types: Control Boxes Linear Actuators Dual Actuators Controls Accessories CBD6DC LA10, LA18, LA40 HOMELINE TD4, TD5 BP10, HC10, HC20, HC40 BA002, CP, BLE2DC, BLE2LIN, LED Light Rail, MD1, SMPS, WiFi2LIN LINAK A/S hereby declares that LINAK MEDLINE ® & CARELINE ® products, characterised by the following models and types: Control Boxes Linear Actuators Lifting Columns Controls Accessories CA10, CA20, CA30, CA40, CA63, CAL40, CB6, CB6S, CB6P2, CB8, CB9, CBJ2, CBJ Care , CBJ Home, CO41, CO53, CO61, CO65, CO71, COL50, OPS, PJ2, PJB4 LA20, LA23, LA24, LA27, LA28, LA29, LA30, LA31, LA34, LA40, LA44 BL1, LC1, LC3 ABL, ACC, ACK, ACO, ACOM, ACL, DP, DPH, FS, FS3, FPP, HB30, HB70, HB80, HB100, HB190, HB200, HB400, HD80, HL70, HL400 BA16, BA18, BA19, BA22, BAJ, BAJL, BAL40, BAL50, CH01, CHJ2 , CHL40, CHL50, DJB, LIN2OB, MJB2, MJB5 Plus, Massage Motor, PJB4, QLCI2, SLS, SMPS10, UBL, UBL2, UBL4 Motion, USB-A Power Adapter LINAK A/S hereby declares that LINAK TECHLINE ® products, characterised by the following models and types: Linear Actuators Lifting Columns Accessories LA12, LA14, LA23, LA25, LA30, LA33, LA35, LA36, LA37, LA76, LA77 LC3 IC FMB comply with the following parts of the Machinery Directive 2006/42/EC, ANNEX I, Essential health and safety requirements relating to the design and construction of machinery: 1.5.1 Electricity supply The relevant technical documentation is compiled in accordance with part B of Annex VII and this documentation or part hereof will be transmitted by post or electronically to a reasoned request by the national authorities. This partly completed machinery must not be put into service until the final machinery into which it is to be incorporated has been declared in conformity with the provisions of the Machinery Directive 2006/42/EC where appropriate. Nordborg, 2024-07-10 LINAK A/S John Kling, B.Sc.E.E., Certification and Regulatory Affairs Authorised to compile the relevant technical documentation Original declaration DDECELCALARARATITOIONNOOF FININCOCORPROPORARATITOIONNOOF FPAPARTRLTYLYCOCOMMPLPELTEETDEDMMAACHCHININEREYRY Copyright © LINAK • 2024-07 • LIT-09-02-001 D
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Controls | 7 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
