6 Product description
6.1 Product Description
6.2 Intended use
6.3 Use for the intended purpose
This bed fulfils all the requirements of the Medical Device REGULATION (EU) 2017/745
(MDR) and is considered a Class I medical device in accordance with the classification rules.
•
This bed is designed for positioning and transporting patients, as an aid to diagnosing,
monitoring, treating, and alleviating illnesses or compensating for injuries or disabilities.
For detailed instructions for use, see chapter Use/routine » 65.
•
This bed is suitable for the following patients:
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Children, teenagers and small adults with a height of 125 cm to 155 cm.
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Patients as described above also with "atypical anatomy" (= for example body
mass index "BMI" of less than 17 or particularly small limbs) or disabilities.
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The bed itself is not life sustaining or life supporting.
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The bed has no medical indication.
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This bed may only be used by qualified personnel within closed rooms in hospitals and
comparable medical facilities.
•
This bed is also particularly suitable for use in units for children and young people
thanks to its special safety features which comply with the latest standard EN 50637 on
medical beds for children and young people.
•
Qualified personnel must be skilled in handling the beds and be thoroughly conversant
with the instruction manual.
•
If the owner of the hospital bed changes, the instruction manual must be handed over
with the bed.
•
The bed with its stable, smooth-running castors is designed for being moved within the
room as well as frequently in corridors and across thresholds with a height of up to 2
cm.
•
The safe working load is 175 kg (patient + accessories).
19 Instruction Manual
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