Vital Elite LTC Bed, Instruction Manual

Page: 7 / 34

Instruction manual
VitalFlex Elite LTC Bed
Last update:03.16.2021 Page 6 of 34
The nursing bed may only be used indoors.
The product must be collected separately. Disposal with normal household
waste is not permitted.
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1.2 Explanation of the designated groups of persons
Operator
The operator of a medical device is any natural or legal person who is responsible for the operation
of the health facility in which the medical device is operated or used by its employees. Contrary to
sentence 1, the operator of a medical device which is owned by a member of the medical profession
or the medical industry and which is brought into a health facility by this member for use is the
relevant member of the medical profession or the medical industry. A person is also considered to be
an operator if he keeps medical devices ready for use outside of health facilities in his company or
facility or in public space.
Requirements to be met by the operator
• The VitalFlex Elite LTC healthcare bed is a medical device and may only be operated and
used in accordance with its intended purpose as the generally recognized rules of
technology.
• Only instructed persons to use this medical device who have the necessary training or
knowledge and experience and who have been instructed in the medical device to be used.
• Instruct the user in the proper handling of this medical device and document the instruction in
an appropriate form.
•
A combination with other medical devices (including accessories) or with other objects may
only be operated and used if they are suitable for use in this combination, considering the
intended purpose and the safety of patients, users, employees or third parties.