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Instruction Manual for Lenus Care Bed
Page 7
2 General information
The Lenus care bed, hereafter referred to as the bed or the care bed, is
manufactured in various models. This instruction manual has been issued for
several bed models. It is possible that certain functions or special features
are described which your bed does not have.
Instructions for the operator:
•
This care bed fulfils all the requirements of the Medical Device Regulation (EU)
2017/745 (MDR). It is classified as a Class I active medical device in accordance
with § 13 of the German Medical Devices Act (Medizinproduktegesetz: MPG).
•
Please observe your obligations as the operator in accordance with the Medical
Devices Operator Ordinance (Medizinprodukte-Betreiberverordnung, German
abbreviation: MPBetreibV), to ensure that this medical product is always operated
safely and with no risk of danger to patients, users, or third parties.
•
Any item of technical equipment, electrical or otherwise, can prove hazardous if used
improperly.
•
Read through this instruction manual from start to finish to prevent any injury or
damage resulting from incorrect operation.
•
Use this bed only as intended by the manufacturer, in accordance with the
instructions in this manual.
•
You are obliged to instruct users in the proper use of this bed in accordance with
MPBetreibV (Operators of Medical Products Ordinance) § 5 (see chapter 4).
•
Ensure that users know where this instruction manual is kept, in accordance with the
Medical Devices Operator Ordinance (MPBetreibV) § 9!
Instructions for the user:
•
Before using a bed, the user must check that the bed is fully functional and in perfect
working order, and must observe the instructions in the manual, in accordance with
the Medical Devices Operator Ordinance (MPBetreibV) § 2. This also applies for
accessories.
•
Read through this instruction manual from start to finish to prevent any injury or
damage resulting from incorrect operation.
•
This instruction manual contains safety information which must be followed! All users
working on and with the Lenus bed model must be familiar with the contents of this
instruction manual and follow the safety information provided before operating the
bed for the first time.
Before using the bed for the first time:
•
Remove all transport securing devices and packaging film.
•
Assemble the bed from the knocked down assembly units in accordance with the
assembly instructions.
•
Clean and disinfect the bed before using it for the first time.