Instruction Manual for Lenus Care Bed
Page 93
9.7 CLASSIFICATION
• This bed fulfils all the requirements of the Medical Device Regulation (EU) 2017/745
(MDR).
• This bed is classified as a Class I active medical product with type BF application
parts.
• UMDNS code: 10-347; Bed (electrically adjustable)
• CDN code: Y181210: SUPPORTS OR TECHNICAL AIDS FOR DISABLED
PERSONS: ORTHOPAEDIC BEDS, 2 ARTICULATIONS, ELECTRIC
• For use in the following application environments in accordance with IEC 60601-2-
52:
Long-term care in a medical facility in which medical supervision is required
and monitoring is provided if required.
A medical electrical device used in medical procedures can be provided to
help maintain or improve the condition of the PATIENTS. (E.g. retirement and
nursing homes, rehabilitation facilities and geriatric institutions)
Care in the home. A medical electrical device is used
to alleviate or compensate for injuries, disabilities or
illnesses.
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